BRC Global Standard For Consumer Products PCH Issue 4

 

BRC Global Standard for Consumer Products PCH Issue 4

1

Senior management commitment

1.1

Senior management commitment and continual improvement

Statement State ment of int ent 

 FUNDAMENTAL 

The site’s senior management shall demonstrate they are fully committed to the implementation of the requirements of the Global Standard for Consumer Products and to processes which facilitate continual improvement of product safety and quality management.

Interpretation The statement of intent for this clause is a fundamental requirement. Without commitment from the site’’s senior management, which has the authority to allocate budget and resources and set site policies, site it is not possible to properly implement the Standard. A department manager or quality manager may think it is a good idea to adopt the Standard and try to address matters on their o own wn initiative, but many of the requirements need support from different parts of the site and demand commitment at the highest level. The requirement encompasses a need to effect continual improvement as consumer quality and safety expectations rise and legal requirements become more complex. Site standards from 20 years ago would not be acceptable today.

Example At the opening meeting, none of the site’s senior management is present. The quality manager informs the auditor that the site’s senior site’s senior management is dealing with an important client and has authorised the quality manager to deputise. The auditor also notices that none of the site’s senior managers were  present at the opening meeting last year. year. The auditor asks the quality manager to ensure that the site’s senior manager is available, but this is not possible. Senior management does not understand the importance of its commitment. If I f the senior management was unavailable due to exceptional circumstances, then the audit visit should have been postponed. The auditor will decide whether to continue with the audit after consultation with the certification body, if necessary, and depending on the conditions of business between the certification body and the site. 

Clause Cla use 1.1.1: 1.1.1: fo undation The site shall have an implemented policy which demonstrates the site’s intention to meet its obligation to produce safe and legal products to the specified quality and its responsibility to its customers. This shall be:

   

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authorised by the person with overall responsibility for the site communicated to all staff.

Interpretation The site’ site’s senior management is required to establish a policy that is understood by all of the employees. This policy needs to address the product safety, legality and quality q uality as well as any customer or customer-specific requirements. At the fundamental level the policy may or may not be in a readily documented format although it needs to be something the site’ site ’s senior management can endorse. This could be achieved through a training programme.

Example During the audit of a site making toilet-rim blocks, the auditor questions one of the line operatives to determine their understanding of the site’s policy. The employee replies that they are not aware of any

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such policy and a further review re view of the employee’s training record shows that they were not trained in understanding the policy during their induction. This would result in a non-conformity as the employee is unaware of the site’ s policy.

Clause 1.1.1: higher The site shall have a documented do cumented policy which states the site’s intention to meet its obligation to  produce safe and legal products to the specified quality and its responsibility to its customers. This shall be:

   

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authorised and signed by the person with overall responsibility for the site communicated to all staff.

Interpretation The site’ site’s senior management is required to document a policy that is understood by all of the employees. This policy needs to address the product safety, legality and quality q uality as well as any customer or customer-specific requirements. At the higher level the policy must be in readily r eadily accessible, documented format authorised by the site’ site ’s senior management. In addition, this should be included in a training programme to ensure that there is a full understanding of the requirement.

Example During the audit of a site making wet-wipe tissues, the auditor questions one of the line operatives to determine their understanding of the site’s policy. The employee replies that they are not aware not  aware of any such policy and the policy is not displayed anywhere on site. A further review of the employee’s training record shows that they were not trained in understanding the policy during their induction. This would result in a non-conformity as the employee is unaware of the site’ s policy.

Clause 1.1.2 The site’s senior management shall ensure that clear objectives are defined to maintain safety and legality and improve the quality of products manufactured, in accordance with the site’s product safety safe ty and quality policy and commitment to implementing the requirements of this Standard. These objectives shall be clearly communicated to relevant staff and monitored, and results reported at least annually to site senior management.

Interpretation The site’s site’s senior management needs to set objectives concerning legality, safety and quality so that the workforce can understand what is required from them. Setting such objectives also enables the allocation of suitable budgets and resources. Auditors will be looking lo oking for evidence that this has been done and communicated to the appropriate staff. Objectives may include, for example:

  reducing customer complaints   fewer non-conforming products    better customer satisfaction scores   fewer lots rejected by customers   improving on time in full delivery   the introduction of Lean principles such as Six Sigma (6∑)  (6∑)     increased production efficiencies (uptime or downtime).

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There are many other objectives that could be included here. In each case, the objective should be measurable and documented. It is then possible to review success or failure. The T he objective is to show a coherent relationship between the objectives and the policy which will subsequently be reviewed at the management review. This will then help to deliver continuous improvement.

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Examples A detergent company has set objectives for the level of customer complaints each year and can demonstrate that it has diligently monitored the complaint levels for the past five years. There T here is no evidence that actions have been taken to address the failure to meet objectives. This would result in a non-conformity. Effort is being made to collect data but it is not being used effectively.

The quality manager of a toy manufacturer shows the auditor a document stating that there are documented key performance indicators (KPIs) set for the level of customer rejects. When the auditor visits the site, none of the operators is aware of this document and there is no evidence that the rejects are being monitored. The auditor is told this is do ne by ‘George’ who is away on holiday.  holiday.    A non-conformity would be raised, raised, as there is no evidence that the KPIs are monitore monitored. d.

A wet-tissue manufacturer has set an objective to reduce the amount of solution rework to less than 1% of production within two years and has set KPIs for various departments in order to achieve this. The auditor is shown monitoring charts from the various departments and the results res ults of the KPIs to support the objective. In addition, there are a number of projects in place to reduce errors at various stages in the manufacturing process. The projects are assigned to designated persons who have the backing of senior management. The auditor would consider this acceptable .

Clause Cla use 1.1.3: 1.1.3: fo undation The site shall have a programme of management meetings which enable product safety, legality or quality issues to be brought to the attention of senior management for resolution. Records of the minutes from these meetings shall be maintained.

Interpretation The site’ site’s senior management needs to determine that the systems and procedures pro cedures are effective in delivering the results required in relation to product safety, legality and quality. The T he meetings are also to determine progress against the set objectives, setting new ones and determining who is responsible within certain timescales. The meetings are required to be undertaken at regular intervals, possibly monthly or quarterly. The evidence that such meetings occur would be minutes of the meetings and diarised future meetings.

Example The auditor is shown handwritten minutes from a meeting with senior management present. The minutes detail the progress being made with the KPIs from the objectives obj ectives set at the beginning of the year. The last agenda item is the date of the next meeting at the beginning begi nning of the next quarter. The auditor would accept the evidence.  

Clause 1.1.3: higher Management review meetings attended by the site’s senior management shall be undertaken at appropriate planned intervals, at least annually, to review the site’s performance perform ance against the Standard and the objectives set out in clause 1.1.2. The review process shall include the evaluation of:

   previous management review action plans and timeframes   results of internal, second-party and/or third-party audits (relevant to the scope of this Standard)   customer complaints and results of any customer feedback    product safety and quality incidents, corrective corrective actions, out-of-specification results and nonconforming materials   management review of the systems for product risk assessment, assess ment, changes in legal requirements and  process performance

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resource requirements.

Records of the meetings shall be documented and used to revise the objectives. The decisions and actions agreed within the review process shall be effectively communicated to appropriate staff and actions implemented within agreed timescales.

Interpretation The management review process is an important part of the system. It usually takes place annually, although other shorter time periods are acceptable. The review should be a specific meeting with a defined agenda. Topics discussed during other events, such as a brief mention of safety matters in a weekly management meeting, do not constitute a review.  Note that this clause gives a list of aspects to be covered. covered. All the bulleted points should be addressed. It is acceptable to consider additional points relevant to the review, but not to omit any of the points listed in the Standard. Second- and third-party audits are audits done by, or on behalf of, customers, or audits carried out by independent bodies (such as a BRC audit).

Example A company has not discussed resource requirements at a meeting because the senior manager does not think that financial and staff information should be disclosed to the technical team.  It is a requirement to discuss discuss resource needs. There There is nothing in the Standard to say that that detailed  financial information has to be revealed revealed and the manager ccould ould have withheld sensitive infor information mation while still addressing the topic.  A non-conformity would result. result.

Clause 1.1.4 The site’s senior management shall provide sufficient human and financial resources required to  produce and improve products safely and and in compliance with the requirements of this Standard.

Example The auditor notes that the quality manager has not attended the last risk ris k assessment meeting, the internal audit programme is behind schedule, and the pH meter normally used to measure the incoming raw material is out for repair (hence no tests are being undertaken). The quality manager explains to the auditor that she is really busy and does not have time to do the audits. Not only this, but money is tight and there is no budget for a new pH meter. The auditor will raise non-conformities against this clause concerning the goods-in process and the internal audit process as they are not in line with the requirements. 

Clause 1.1.5 Where the site is certificated to the Standard, it shall ensure that announced recertification audits occur on or before the audit due date indicated on the certificate.

Interpretation A number of situations may arise when a late audit is acceptable. For example:

       

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the area around the factory is closed due to government restrictions the site is not operational as it is flooded or there has been a fire the auditor cannot travel due to severe weather there is a war in the region and the auditor is advised not to travel.

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It is the responsibility of the site to adhere to the audit date and it would not be acceptable if the quality manager was ill or the management team had other appointments.

Example The site is overdue for the audit by one week and the management has no explanation for the lateness. The auditor will raise a non-conformity no n-conformity during the subsequent visit. 

Clause 1.1.6 The site shall have a genuine hard copy or electronic version of the current Standard available with a  position statement and be aware of any changes to the Standard or protocol that are published published on the BRC website.

Interpretation The site could subscribe to BRC Participate which would address the requirement to be aware of BRC  publications and make the Standard available available in an electronic format. The site could could also download a copy free of charge from the BRC Bookshop.

Example The auditor asks to see the site’s copy of the t he Standard and is shown a printed copy. The Th e auditor then asks to see where the Standard came from and is directed to the BRC Participate website, to which the quality manager has access. The auditor would accept the evidence.  

Clause 1.1.7 Where required by legislation, the site shall be registered with or approved by the appropriate government agency and evidence of this shall be available.

Interpretation This clause does not apply to all products. It refers to the requirement for some sites to be registered concerning the safe production of their products. Auditors will expect to see evidence of up -to-date registration for the correct range of products. A number of products require r equire the licensing of the site and/or the product itself, while other products are subject to voluntary codes. Cosmetics

Each cosmetic product must be notified to the European Commission using the Cosmetic Product P roduct  Notification Portal (CPNP) prior to placing the product product on the market. The Food and Drug Administration (FDA) does not license cosmetics firms. However, state or local authorities may require licensing or have other requirements you need to know about. The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by manufacturers, packers and distributors of cosmetic products that are commercially distributed in the United States.  Medical devices

If you place certain medical devices on the EU market, you or your authorised representative (agent) must be registered with the competent authority (national health regulator) in the EU state sta te where you have an office or place of business. In the UK, the Medicines and Healthcare Products Agency (MHRA) is the competent authority for the registration of medical devices. MHRA will only register manufacturers or authorised representatives that have a place of business in the UK.

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Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA. This process is known as establishment e stablishment registration.

Clause Cla use 1.1.8: 1.1.8: fo undation A system shall be in place to close out non-conformities non-co nformities raised with consideration of the root cause.

Interpretation Within the management team there needs to be an understanding of the techniques used to determine root cause when a non-conformity is raised during a third-party third-par ty audit. Normally there are 28 days (90 days for a first audit) to close out the issue raised (corrective action) and in addition the site must determine the long-term corrective action in order to prevent recurrence.

Clause 1.1.8: higher The site’s senior management shall ensure that the root causes of non -conformities identified at the  previous audit against the Standard have been been effectively addressed to prevent recurrence. recurrence. A system shall be in place to close out non-conformities non-co nformities raised at internal, second-party and third-party audits, with consideration of the root cause.

Interpretation Within the management team there needs to be an understanding of the techniques used to determine root cause when a non-conformity is raised during a third party part y audit. Nominally there are 28 days (90 days for a first audit) to close out the issue i ssue raised (corrective action) and in addition the site must implement the long-term corrective action in order to prevent recurrence. The site’ site ’s senior management team is also required to review the effectiveness of the action taken.

Example  Applies at both foundation and higher levels levels 

During the audit the auditor raises a non-conformity because a production record is incomplete. Twenty days later the auditor is sent details of the closure clos ure of the non-conformities raised during the last audit. This includes a copy of the internal audit of the production p roduction records which shows that all records were completed following a toolbox talk (an informal group discussion that focuses on a specific issue). In addition, the site also sends information regarding the toolbox t alk and a ‘five whys’ whys’  document showing the root cause of the issue, which was that the paperwork was used by several of the  personnel, some of whom took the paperwork paperwork to the processing area in order to record the data. This meant that on occasions the paperwork was not available to the other team members and they sometimes forgot to add the data after the event. The toolbox talk was not just a retraining exercise but the demonstration of a new way to capture the data for all staff using a personal digital assistant (PDA). The auditor would accept the evidence provided .

1.2

Organisational structure, responsibilities and management authority

Statement State ment of int ent The site shall have a clear organisational structure and lines of communication co mmunication to enable effective management of product safety, legality and quality.

Interpretation If an organisation is well-structured with clear roles, reporting lines and responsibilities , it is much simpler to communicate with staff and manage the site. This requirement applies to a ny type of site,

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whether small or large, and whether making simple low-risk products or o r more complex items. In all cases the same principle applies, even though the actual structures needed may be more complex in some cases.

Clause 1.2.1 The site shall have an up-to-date organisation chart for key staff demonstrating the management structure of the company. The responsibilities for the management of activities which ensure product safety, legality and quality shall be clearly allocated and understood by the managers responsible. There shall be clear evidence of who deputises in the absence of the responsible person.

Interpretation There is a requirement for an organisation chart. The Standard specifies a chart, so text describing the organisation will not be sufficient. Additionally, the site must clearly state who deputises for whom. This also implies that the deputy should understand the requirements of the job j ob they are deputising for. There may be more than one person deputising for another. Production, and any associated as sociated problems, will continue when people are off sick or on holiday. It is unacceptable to produce unsafe products  because someone was absent, and action on withdrawals or recalls will not usually wait for someone to return to work. Even on a small site, written procedures that make arrangements to cover absence are required to remove any doubt as to who is responsible for what –  what –  for  for example, by appointing deputies. It is particularly important that the site provides cover for the individual with nominated responsibility for safety and quality. This is another indication of management commitment.

Clause 1.2.2 The site’s senior management shall ensure that all employees are aware of their responsibilities. Where documented work instructions exist for activities undertaken, the relevant employees shall have access to these and be able to demonstrate that work is carried out in accordance with the instructions. A senior member of staff should be identified with responsibility and authority to stop production, pr oduction, if required.

Interpretation This clause requires that there are instructions for general work duties, which are communicated in addition to information concerning particular product productions or individual items of equipment. Many general procedures –  procedures –  such  such as those for methods of work, housekeeping and site systems s ystems –   –  can  can contribute to the assurance of safe products and could, therefore, be detailed. These general requirements may sometimes be part of a job description or contained in a general s ite manual. Detailed instructions on how to carry out specific tasks may be recorded in work instructions. These documents contain the practical details of how to carry out tasks in a form easily understood by the employee. They can be pictorial, diagrammatic, in text format or a combination of all three.

Examples A company cleaner is provided with detailed instructions about cleaning duties. The site has a cleaning  procedure covering general requirements requirements but the cleaner’s work instructions include:

         

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details of the area to be cleaned schedule to be followed how to clean –  clean –  what  what materials to use how to dispose of waste materials how to fill in a log book to show sho w that work has been completed.

The instructions are provided in simple text and in a language that the cleaner understands. The auditor would consider this to be satisfactory.

Production-line workers in a cosmetics factory have work instructions in the form of flow charts and diagrams, provided at each station. These clearly show how to mix ingredients together, to gether, and include:

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how to check the formulation being made the order of adding chemicals how to transfer chemicals to the vat and control quantity mixing time mixing temperature and how to record it what to do when batch mixing is complete, and how to sign off how to record the batch production.

The instructions provided are referenced, approved and dated. The individual formulations are also recorded and approved and have to be checked by a supervisor before production begins. The auditor would check that all aspects of the batch-mixing batch- mixing production are properly included and can be understood by the employees.

Production-line workers in a television factory have work instructions in the form of flow charts and diagrams, provided at each station. These clearly show how to assemble the components, and include:

             

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how to check the circuits the order of assembly how to ensure that there is no possibility of static solder bath temperatures Hi Pot1 test parameters what to do in the event of Hi Pot failure how to record the batch production.

The instructions provided are referenced, approved and dated. The individual specifications are also recorded and approved and have to be checked by a supervisor before production begins.

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 Hi Pot stands for high potential. potenti al. A Hi Pot test is used to test the insulation of a product far beyond the voltages it would normally encounter.

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2

Product risk management

Statement State ment of in tent  FUNDAMENTAL 

The site shall have a management process in place to ensure that a risk assessment as sessment is completed on each product group to ensure safety, legality and quality in the regions of intended sale, where known.

Interpretation This fundamental clause is about the management of the scheme and ensuring that information is available to support full risk assessments. It stresses that the management must be comprehensive and systematic, so the availability of a few isolated risk reports on a small proportion of products would not  be deemed sufficient. The concept of risk should should be integral to the whole operation. This is a fundamental clause because an understanding of risk and management of the procedures and processes using a risk-based approach is essential to the implementation of the Standard. Auditors will look for systematic product and process risk assessments, and decisions made on the basis of risk. The whole clause has been deemed fundamental, rather than individual subclauses, because each part is important to the operation of a site in conformity with the Standard. In order to decide whether a product is likely to cause injury it is helpful to review past injury data. Finding information and data about injuries that have occurred can be difficult. Sites may have their own information resulting from customer complaints (or lack of complaints), and information may be available from the authorities. Details provided with product recalls may also highlight injuries that are known to have occurred. The USA has a website which gives detailed injury reports: www.cpsc.gov/LIBRARY/neiss.html The European injury database also gives some information on types of injury: https://webgate.ec.europa.eu/idb

2.1

Legislation and safety requirements

Clause 2.1.1 The site shall have a system to demonstrate knowledge of all applicable legislation, product standards and product safety issues in the place of production and regions of intended sale of each product. This may be within the company or by use of external expertise.

Interpretation The site may have access to applicable websites such as:        

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http://eur-lex.europa.eu/ http://www.legislation.gov.uk/ https://www.usa.gov/ http://www.lawinfochina.com/legal

An affiliation with test houses, trade associations and consultants will also support the information requirements.

Examples Set out below are some examples of legislation for different products from fro m around the globe. Legislation changes on a regular basis, and although great care has been taken to ensure this is correct at the time of issue, the legislation will need to be reviewed r eviewed to ensure it is up to date. Also, you should refer to the general legislation and/or product-specific legislation as well as codes of practice. pr actice.

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United Kingdom and Europe

In the UK the Sale Sale of Goods Act 1979 requires that all products must be ‘fit for purpose’, of satisfactory quality and fit their description. This means that your products must fulfil the purpose the customer has been led to expect and the reasons that led them to buy it. Consumers are protected by the Consumer Rights Act 2015. In the EU, the General Product Safety Directive (GPSD) 2001/95/EC refers to products that do not have specific regulation. The Waste Electrical and Electronic Equipment Directive (WEEE Directive) is the European Community directive 2012/19/EU on waste electrical and electronic equipment (WEEE). This, together with the RoHS Directive 2002/95/EC, became European law in February 2003. In Europe the consolidated version of the Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the registration, evaluation, authorisation and restriction of chemicals (REACH) sets out, among other things, that AZO dyes (which may release one or more of the 22 aromatic amines in detectable concentrations, above 30 ppm in the finished articles or in the dyed components) may not  be used in textile and leather leather articles that may come into direct and prolonged conta contact ct with the human skin or oral cavity. Since Annex XVII of REACH came into force in 2009, the AZO Directive 2002/61/EC has been replaced by the REACH regulation. AZO dyes are now on the REACH restriction list. Washing powders and detergents are regulated by EC Regulation EC No 648/2004 on detergents. The regulation establishes common rules to enable detergents and surfactants to be sold and used across the EU, while providing a high degree of protection to the environment and human health. The T he 2012 amendment introduced new limits to reduce the damage phosphates from detergents may have on ecosystems ecosyst ems and water quality, which is a phenomenon known as ‘eutrophication’.  ‘eutrophication’.   For cosmetics in Europe, the following legislation applies:

  EU Cosmetics Directive 76/768/EEC    New Cosmetic Products Regulation (EC)1223/2009. (EC)1223/2009.

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CE marking applies to a range of products, from fro m electrical equipment to toys and from civil explosives to medical devices. CE marking is covered by the following legislation:

     

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2001/95/EC: (New) General Products Safety Directive 93/68/EEC: ‘CE Marking’ Directive  Directive   93/465/EEC: Conformity Assessment Procedures & CE Marking Rules.

Even if your product is manufactured outside the EEA, you must ensure that it bears CE marking if it comes under the scope of a directive requiring CE marking. Not all products sold in the EU need to  bear CE marking. The following categories of product require CE marking if you wish to sell them within the EU or member states of the EEA:

  toys   electrical products   construction products    pressure vessels   telecommunications equipment   medical devices   machinery, equipment and safety components    personal protective equipment   satellite station equipment   gas appliances

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   pressure equipment   appliances (other than gas)   non-automatic weighing instruments and equipment   measuring instruments   recreational craft   lift machinery   equipment and protective systems for explosive atmospheres   in vitro diagnostic medical devices   marine equipment   safety components and subsystems for incorporation into cableway installations   cableway equipment (ski tows etc.).

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China

In China the Restriction of Hazardous Substances (RoHS), officially known as the Administrative Measure on the Control of Pollution Caused by Electronic Information Products, is a Chinese government regulation to control certain materials, including lead. There are currently six substances considered environmentally hazardous by the China RoHS directive:

  lead   mercury   cadmium   hexavalent chromium    polybrominated biphenyls

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   polybrominated diphenyl ethers.

The China RoHS does not allow any technology exemptions, unlike the EU RoHS 2 Directive. The pr oduct oduct quality law of the People’s Republic of China consists of two articles:

 

Article 1 This law is enacted for the purposes of strengthening the supervision and administration of product quality, improving product quality, determining the liability of product quality,  protecting the legal rights and interest of consumers, and and safeguarding the social economic order. Article 2   Those who undertake the production and sale of products within the territory of the People’s Republic of China must abide by this law.  law.  

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United States of America

In the US consumers are protected by the Federal Trade Commission (FTC), ( FTC), which maintains and  pursues law enforcement through federal and and state legislatures, including US and international government agencies. The Consumer Product Safety Commission (CPSC) imposes new testing and documentation requirements and sets new acceptable levels for several substances. Those affected include manufacturers of apparel, shoes, personal care products, accessories and jewellery, home furnishings, bedding, toys, electronics and video games, books, school supplies, educational materials and science kits. Toys and children’s products sold in the US are covered by HR 4040, the Act known as the Consumer Product Safety Improvement Act of 2008. The sections that apply are as follows:

               

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Children’’s products containing lead; lead paint rule Children Mandatory third pa party rty testing for certain children children’’s products Tracking labels for children children’’s products Standards and consumer registration of durable nu nursery rsery products Labeling requ requirement irement for adve advertising rtising toys and games Mandatory toy safety standards Study of preventable injuries an and d deaths in minority children related to consumer products products Prohibition on sale of certain products conta containing ining specified phthalates

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Specific import-export provisions include:

         

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221 Export of recalled and non-conforming non-conforming products 222 Import safety management management and interagency cooperation 223 Substantial product h hazard azard list and destruction of noncompliant imported products 224 Financial responsibility 225 Study and report on effectiveness of authorities relating to safety of im imported ported consumer  products

In the US the Lacey Act Amendments of 2008 prohibit the sale of certain animal-derived animal -derived products, such as feathers, and wooden products. It requires that no Lacey Act ‘prohibited species’ is sold and that the retailer shows ‘due care’. This means that a person facing a particular set of circumstances must undertake certain steps that a reasonable person would take to do their best to ensure that they do not violate the law. They should also check botanical resources (such as the GRIN taxonomy) to confirm:

   

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the validity of any scientific names the geographic distribution.

Additional non-Lacey regulations apply for products imported to the US. Composite wooden products are also required to meet CARB-ATCM 91320/S.1660-formaldehyde emission from composite wood products. For cosmetics in the US, the following legislation applies:

   

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Safe Cosmetics Act of 2011 (H.R. 2359) California Safe Cosmetics Act (SB 484).

For cosmetics in Canada:

   

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Canadian Environmental Assessment Regulations Canadian New Substances Notification (NSN) Regulations.

Clause 2.1.2 If the site relies on information concerning product safety, quality and legality provided by their customer or a third party, it shall have a process in place to validate the credibility of the provider of the information and retain evidence of this validation.

Interpretation On large sites there may be a team which has the sole responsibility r esponsibility of following product safety information. Small sites, on the other hand, may have no such specialist team and may just view safety as something that ‘gets in the way’ way’ of production. In many cases, sites rely on information supplied by their customers or independent consultants. This may take the form of a customer quality or safety manual, or may be more specific to an order order –   –  such  such as, ‘We need a test report showing compliance with … standard before we will accept this order’ or der’.. Such information is helpful and forms a good basis, but the following should also be considered:

 

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Customer information should be systematically stored and acted upon. It builds into a knowledge system about product requirements. Customer manuals must be the current versions and checked frequently for updates. Customers are not always right. They may ask for the wrong tests or miss something so mething important. Don’’t assume they are right and check from another source Don so urce whenever possible. Back up any information from more than one source, such as trade association certification body newsletters, legislative portals and websites.

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When sites wish to sell their products in diverse geographical markets, often working in languages that they don’ don’t understand, this becomes more difficult. Whatever the system, it is vital to update it frequently as new issues emerge, and changes in legislation and standard updates regularly occur. The site can review the government sites (examples below) in order to ensure that the information infor mation is correct:

   

Electronic Code of Federal Regulations (E-Cfr) legislation.gov.uk

 

europa.eu/eu-law/index_en.htm

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Example A small giftware company has little expertise on product safety so it has signed s igned up for safety updates from two independent test houses and also to receive notification of all product recalls in its sector. The administrator is tasked with routinely checking this information. The administrator has been on a short training course to help them understand the issues and has a contact at the test house to consult for more information. The administrator is also responsible for logging any client requests concerning safety. The auditor should find this satisfactory. A system appropriate to the level of the operation is in place and as information is from various sources, cross-checking is also evident.

Clause 2.1.3 The company’s company’s senior management shall have a system in place pl ace to ensure that the site is kept informed of and reviews:

       

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changes in legislation scientific and technical developments industry codes of practice new risks to raw materials, components, packaging and finished product.

Any changes shall be implemented in a timely and controlled manner or as defined by legal requirements.

Interpretation The best system of information gathering is of no use if the information is not acted upon. This clause ensures that any changes are adopted in a timely manner. Most changes allow a reasonable time for implementation before they are enforced, and they may require:

         

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additional cost redesign of product sourcing of new materials training of staff new packaging or labelling.

Procedures should be in place to ensure changes are adequately considered within an appropriate timescale.

Clause 2.1.4 Copies of applicable legislation, standards, codes of practice and similar documents shall be available to relevant staff.

Interpretation The legislation may be accessible through the internet as long as the relevant personnel can have access to the documents. Codes of practice may come directly from the customer and these should be implemented into the systems and procedures. Any changes should be reflected r eflected through the system.

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2.2

Product risk assessment

Clause 2.2.1 The company shall ensure that a product hazard and risk assessment is undertaken for each product or  product group. The assessment shall be documented documented and include:

 

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a description of the product assessed (for example, approved samples or mock-ups, sample drawings, computer graphics, photographs, specification) the intended use of the product and foreseeable abuse conditions the hazards, the risk level for each hazard and whether the risk is i s acceptable the date performed, name of the person responsible and the evidence from which the assessment was derived.

If the assessment indicates that a product may present an unacceptable risk to consumers, that product shall not be produced by the site. If the product requires modification, a new risk assessment shall be completed on the modified design.

Interpretation This clause ensures that proposed designs and materials allow for the production pr oduction of safe and legal  products. A risk assessment of the product design and materials is essential to ensure a safe and legal legal  product. This assessment should address matters such as:

 

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the materials used in the make-up –  make-up –  to  to ensure that they have the correct mechanical properties such as strength and durability the chemical composition of materials –  materials  –  to  to ensure that toxic or dangerous substances are not used the assembly of the parts –  parts  –   to to ensure that the materials work together (for example, the correct type t ype of adhesive) the mechanical assembly –  assembly –  for  for example, screwing or gluing the technical features of the design –  design –  such  such as the shape of moulds or the fit of components.

It is likely that the assessment will be carried out over different stages, starting with the concept drawings and continuing until the first pre-production samples are produced. pr oduced. Assessment of the product design should then continue based on feedback obtained from all sources. Once a site is in routine production, it may not be necessary to carry out a complete assessment for every variant. However, changes should not be made without an assessment of the new parts or materials, and the likely effect on the product. Sites may be concerned about sharing confidential information, formulations and design details with the auditor. Auditors must All be able to are view sufficient information infor mation ensure thatauditor. the siteNo hasproprietary made a or complete risk assessment. audits confidential between the to site and the design/formulation information is released on the audit report and the site can decide wheth er to allow its report to be viewed by third parties. It may be that the product design is supplied to a site and that the site has no input into the risk assessment of the product. In these situations, a site sometimes thinks that the risk assessment process is not relevant, and that all it needs to do is produce items to the specification it has been given. This misconception has caused a number of unsafe products to reach the marketplace. When the product design is supplied to the site it is essential that the site:

     

has a formal written specification is provided with a validated copy of the risk assessment, if this exists is able to carry out an assessment or commission an assessment if one does not exist. If an assessment is commissioned the site must validate the capability of the external party to conduct

 

the risk assessment has formally agreed to abide by the content

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has a system in place for communicating key information to the workforce and back to the specifier, if necessary has a procedure for taking the design risk assessment asse ssment and producing a process risk assessment, establishing any key control points in the process.

It is not acceptable for a site to produce an unsafe or illegal product p roduct because it was supplied with a faulty design brief.

Example A candle maker has a design of candle which it has made and sold successfully and safely for many years in a range of colours. It decides to add a dark red colour to the range and assumes it will be satisfactory because of its record. The company receives several complaints about candles flaring up, and is informed of one fire incident. On investigation, it is found that the red pigment affects the burning characteristics of the wax, giving rise to high, smoky flames and a nd unstable burning. A check of the pigment characteris characteristics tics or a test burn following a risk assessment of the change to the original product may have avoided these  problems.

A hair dye manufacturer has developed a system which it has made and sold successfully and safely for many years in a range of colours. It decides to add a dark red colour to the range and assumes it will be satisfactory because of its record. The company receives several complaints about skin irritation, and is informed of one serious skin complaint. On investigation, it is found that the red pigment affects the characteristics of the product, giving rise to higher sensitivity in some users. A skin trial of the p pigment igment characteristics following a risk assessment of the change to the original product may have avoided these pro problems. blems.

Clause 2.2.2 The risk assessment shall be produced by suitably trained and competent internal or external resources. Evidence of this shall be available unless the risk assessment is provided by the customer. Staff with responsibility for decision-making shall be trained to ensure they understand risk assessment  procedures or outcomes necessary for their activity. activity.

Interpretation In order to conduct a satisfactory risk assessment, the manager in charge (risk assessment team leader) must be competent and the rest of the team should understand the principles that are used. Methods of risk assessment could include:

     

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Design Failure Mode Effect Analysis Fishbone or Ishikawa diagram Hazard Analysis Critical Control Point (HACCP).

It is very unusual for one person to be able to carry out the entire assessment; it is i s likely that a team of  people will be required. For example, example, an engineer who can evaluate evaluate the strength of a moulding may not  be able to evaluate the toxicity of the materials used to make the product. A suitable team should be assembled to cover all aspects and there should be a designated responsible r esponsible  person of sufficient authority to approve the outcomes. outcomes. The team must have the commitment of senior management. This does not mean that a whole range of staff has to be employed for the purpose. While this may be appropriate for very large, complex operations, it is more likely that the duties will form for m just a part of someone’s job, or external resources will be used. There are numerous third parties tha t hatt provide risk assessment services,for but they be correctly theproducing site’s products and processes. final responsibility the riskmust assessment will rest rbriefed est withabout the site the items and, at the The very least, a staff member at the site should coordinate and be responsible for the assessment.

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For a product risk assessment, the team is likely li kely to include some of (but is not limited to) the following:

                 

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designers chemists materials scientists human factors specialists, such as ergonomics experts or child psychologists engineers quality assurance staff line operatives hygiene staff legal staff.

Clause 2.2.3 The site shall determine and maintain up-to-date information about the legislation and mandatory standards applicable to each product and to the materials from which it is made, relevant in the regions of intended sale.

Clause 2.2.4 The risk assessment shall be reviewed at least annually, and following any significant complaints co mplaints or incidents, to ensure that the assessment remains up to date, and a nd reflects any changes in specification, manufacturing process and legislation.

Interpretation A regular review is necessary because new safety information may have been published, there may have been recalls of similar products or the legislation may have hav e changed. In general, consumers’ expectations of safety increase over time. A good example is passenger cars, which originally did not have seat belts and, until recently, did not have air bags. Electrical equipment was purchased in the past without a ‘plug top’ whereas today all electrical items come with a plug top fitted, thus reducing r educing the incidence of electrocution due to poorly fitted plug tops. Reviews can be carried out more frequently if required. Where products are made for less than a year and the risk assessment is no longer relevant to production, there is no need to conduct a full review but any complaints or incidents relating to products no longer in production should still be part of a review  process. The review should be carried out by those responsible for risk assessments and a summary reported to senior management as part of the overall system review.

Examples A company has a good system and most of the documentation is in order. The T he auditor finds that the risk assessment has not been reviewed following a change of supplier for a component. Following further investigation, although the component has had no detrimental effect on the product, the auditor is likely to raise a minor non-conformity. The company needs to take care that the system is operated correctly but there are no real concerns that there is a breakdown of the system or that  product safety is compromised. compromised.

A company has some risk assessments documented but they are not signed s igned or dated. It is not completely clear whether assessments have been reviewed in the past 12 months. This would warrant a major non-conformity non -conformity as the Standard is systematically not being adhered to. It is not a critical non-conformity as some aspects of the Standard are in place and the auditor does not consider that the lapse will result in an unsafe or illegal product.

A factory has a team responsible for carrying out a risk assessment asse ssment of product design. There are representatives from the design, production, quality assurance and management teams and all team members have had training in risk assessment. Each product idea is passed to the team at each stage of development and a full report produced and signed by the team leader. Any additional external

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resources or information are included in the documented risk assessment assess ment pack along with the team findings. Procedures have been followed correctly and an auditor would be satisfied by this approach.

Clause 2.2.5 Where there is a legal requirement to do so or when it is necessary to confirm its safety or legality, legali ty, a representative product should be submitted for testing to a suitably qualified and, where applicable, an accredited laboratory (internal or external). The results of the test should form part of the risk assessment.

Interpretation This clause addresses the specific cases when testing of a product pro duct that is representative of overall  production must be carried out because of legislation. It will often be the case that the allowed test organisations are also specified. s pecified. This would be true, for example, of a toy, a cosmetic product or children’s clothing, or indeed any product requiring CE marking.

Example The two most important laws pertaining to cosmetics marketed in the United States are the Federal Food, Drug, and Cosmetic Act (FD & C Act) and the Fair Packaging P ackaging and Labeling Act (FPLA). The FDA regulates cosmetics under the authority of these laws. The FDA advises manufacturers to use whatever testing is necessary to ensure the safety of their products and ingredients. i ngredients. The companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products.

Clause 2.2.6 Where legally required, the identity, competence, qualifications and/or licence of o f the person producing the safety review or risk assessment shall be documented and verified.

Interpretation A competent person is someone who has sufficient training, experience, knowledge and other qualities that allow them to assist the site properly. The level of competence required will depend on the complexity of the situation and the particular help needed.

Examples In US law, competence concerns the mental capacity of an individual to participate p articipate in legal  proceedings or transactions, and the mental mental condition a person must have to be responsible for his or her decisions or acts. Competence is an attribute that is decision-specific. In Europe the Cosmetics Products Regulation (EC) 1223/2009 requires there to be a ‘responsible  person’. This is the person or business within the EU who places a cosmetic cosmetic product on the the market.  market. It may be any one of the following persons:

         

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the manufacturer (if based within the EU) a representative of the manufacturer appointed under a written mandate the importer of the product into the EU a representative appointed under written mandate by the importer into the EU a distributor who modifies a product already on the market or by applying its own name or trade mark to the goods (i.e. own branding).

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2.3

Product labelling and claims

Clause 2.3.1 The site shall verify that information shown on primary p rimary (consumer) package labels and outer cartons is correct and meets the regulatory and safety requirements of the region of intended sale.

Interpretation Because consumers usually receive products in some type of packaging, the specification of the  packaging can be as important important as the product itself. For many products there are regulatory requirements about the amount of packaging that can be used, its composition, and labelling or marking requirements. The site should assess and document its packaging in i n this respect. Mislabelling is a common problem. Labels should be stored appropriately and separated to prevent confusion. This is particularly important when different language versions of a similar label are being used. Care should also be taken to use labels in order ord er of production so as to prevent old, out out-of-date -of-date stock remaining and being inadvertently used. Likewise, Li kewise, products and labelling need to be carefully monitored during changeover periods to ensure that the correct labels are applied. Sites should ensure that the responsibility for all language versions of label copy is clearly defined. It is expected that this information would be part of the technical file.

Examples Cosmetics

The two most important laws pertaining to cosmetics marketed in the US are the Federal Food, Drug, and Cosmetic Act (FD & C Act) and the Fair Packaging and Labeling Act (FPLA). The FDA regulates cosmetics under the authority of these laws.  Household products

A site produces bleach. It sells the item in a bottle with a child-proof opening but it considers that there is still a small risk of someone ingesting the bleach. It has labelled the bottle with instructions on what to do if someone does swallow the bleach and  provided an emergency helpline. helpline. The bottle also has raised labelling in Braille so visually impaired  people know its contents. This would be acceptable to the auditor.  Nappy sacks

A site producing nappy sacks will need to take into account the risk of suffocation to babies where a sack has not been properly disposed of. Appropriate packaging must be labelled with clear warnings.

Clause 2.3.2 The site shall have a process in place to ensure that any claims made about a product shall be fully validated to ensure that products meet the stated claim.

Interpretation The most claims made most frequently for a product are about size, weight, volume or quantity. Sites need documented procedures to check that any claims made are accurate. The tolerable negative error is related to the nominal quantity. It varies between 9% on pre-packages nominally of 50 g or 50 ml or less to 1.5% on packages nominally of 1 kg or l or more. In the US, the Fair Packaging and Labeling Act (FPLA or Act), enacted in 1967, directs the Federal Trade Commission and the FDA to issue regulations regulation s requiring that all ‘consumer commodities’ be

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labelled to disclose net contents, identity of commodity, and name and place of business of the  product’s manufacturer, packer, or distributor. The Act Act authorises additional regulations where necessary to prevent consumer deception (or to facilitate value comparisons) with respect to descriptions of ingredients, slack fill of packages, use of ‘cents‘cents -off’ or lower -price -price labelling, or characterisation of package sizes. The Office of Weights and Measures of the National Institute of Standards and Technology, US Department of Commerce, is authorised to promote to the greatest  practicable extent uniformity in State State and Federal regulation of the labelling of consumer consumer commodities. Sometimes sites make particular claims about products –  products –  for example, ‘washable‘washable -ink pens’, ‘suitable for children 3 to 6 years’, ‘sun protection factor 10’, etc. Whenever W henever a claim is made, there should be evidence to substantiate that it is correct and justified. This evidence must be documented and reviewed at intervals, and the methods determined.

Examples A suntan lotion company has rated a product as factor 10. It has done this t his on the basis of copying a competitor’s formulation and has no evidence to show that the factor is correct.   The auditor would find this to be a non-conformity and, depending on the technical information about the formulation, could decide that the product was unsafe.

A company claims that its washing machine is the ‘quietest on the market’. Although this was true several years ago, the company has not kept up to date with research. Several models are now no w available that are quieter; the claim is no longer valid and should be removed.  An auditor may be aware of the situation and challenge the claim. claim.

Clause 2.3.3 Where applicable, the site shall ensure that product-in-use evaluation (internal or external), reliability trials and shelf-life tests are validated. It shall be verified that the production of a safe and legal product is maintained, taking account of the category of consumers at risk.

Interpretation For products that claim a certain level of performance there needs to be evidence that they actually meet such claims. Products such as cosmetics usually have a ‘best before end or ‘use after opening’ date on them and stability trails must be conducted to ensure that the t he product is usable within these time periods. For fabricated products, tests are usually necessary to establish that a product is fit for purpose and likely to endure for a suitable (or guaranteed) use period –  period  –  for  for example, light bulbs are tested to establish their minimum life. It is expected that a site would provide documentary evidence to substantiate any statement regarding shelf life or minimum durability, taking into account environmental conditions or usage that the  product would need to withstand during during the stated period.

Example A company producing shampoo labels the bottles with the net weight. The weight is described using the European average weight system. The company is obliged to check a defined number of products pr oducts and to record that the average weights are within the defined acceptable tolerances. The auditor is likely to ask to see an example of the records and, if they are not available, a nonnon conformity would be raised.

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2.4

Packaging materials

Clause 2.4.1 Packaging shall be assessed for fitness for purpose and found suitable with regard to:

   protecting the product from damage damage   maintaining product integrity    protecting the consumer from injury

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   preventing contamination.

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Interpretation Because consumers usually receive products in some type of packaging, the specification of the  packaging can be as important important as the product itself. For many products there are regulatory requirements about the amount of packaging that can be used, its composition, and labelling or marking requirements. The site should assess and document its packaging in this respect. Additionally, the packaging must be suitable for its purpose in protecting the product from damage or contamination and itself being safe when handled by consumers. The packing process must not increase the risk of producing an unsafe product. In this respect there is legislation le gislation regarding the levels of heavy metals. This is enacted in the UK by The Packaging P ackaging (Essential Requirements) Regulations 2015 and in Europe the Council Directive on Packaging and Packaging Waste (94/62/EC). The aggregate heavy metal limits apply appl y to cadmium, mercury, lead and hexavalent chromium in  packaging or packaging components. They require that the total by weight of such metals should not exceed 100 ppm (subject to some exemptions). Auditors will look for evidence of rejected packaging materials and will examine how the rejected material is treated. Such material should be subject to the process for non -conforming products and suitably recorded, segregated, disposed of and reworked as necessary.

Example A company includes sachets of silica gel in its packing in order to keep products dry. The silica gel is contaminated with an irritant chemical that causes injury to customers. The company is made aware of this through a product safety information sheet and takes action to use a different material. It has documented the actions and removed the contaminated packets from stock items. The auditor is satisfied that the company took appropriate action on packaging once the information became available.

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3

Product safety and quality management

3.1

Product safety and quality management system

Statement State ment of int ent The site’s processes and procedures to meet the requirements of this Standard shall allow consistent application, facilitate training, and support due diligence in the production of a safe and legal product to agreed quality.

Clause 3.1.1 The site shall have an established quality management system (QMS) in place which is a ppropriate to the size of business and risk associated with the products. The QMS shall be fully implemented, collated in a navigable and readily accessible way, and translated into appropriate languages if necessary.

Interpretation Documentation may be produced and stored in several different ways, including electronic copies, databases, intranet systems, photographs and diagrams. Records must be permanent (or at least have a defined lifetime) and therefore adequate storage or back-up systems will be necessary. This Standard does not specifically demand a quality manual, although there are many instances where documentation is required and many sites will find it easiest to collate this into some kind of manual. If a manual is used it must be readily accessible to those t hose who need it.

3.2

Documentation control

Statement State ment of int ent The site shall operate an effective document control system to ensure that only the correct approved versions of documents, including recording forms, are available and in use.

Interpretation When a document is changed, a record needs to be made of the change and the reason for it. This can  be achieved by keeping keeping a copy of the previous version with the reason for change change written on it, or by keeping a ‘history of amendments’ log.  log.  

In documents must be available where when they are out needed, andrequirements, controlled so thatorder theretoisbe nouseful, confusion between different versions of theand same document, -of-date alterations made by writing unauthorised notes on the margins of specifications, and other similar issues. The method the site uses to control documents should be documented as a procedure or work instruction, so that any member of staff producing documents understands the system and operates in the same way.

Examples An auditor notices a print worker adding thinner to an ink and consulting a piece of paper that appears to give mixing proportions. The piece of paper has no identification or date. When consulted, the print worker says that they had been given the instructions by the person who ran the machine previously, and that this was always used to make sure the press ran smoothly.  A document that is important to to the correct functioning of the pr process ocess should be controlled and authorised. A non-conformity would be raised.

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An auditor notices that throughout the factory all documents appear suspiciously clean and new. Because they are in such good condition, the auditor is unconvinced that people are actually using the documents. However, when the staff are consulted, the auditor finds that they use the t he documents and are well informed, and that the quality assurance manager produced new copies of everything the day  before the audit to create a good good impression. This is acceptable and would not result in a non-conformity, non -conformity, although the extra work was unnecessary. The auditor expects to see a working site and not a showcase. As long as the system is operating well, a little wear and tear is to be expected.

Clause 3.2.1: foundation The site shall be able to demonstrate that key documents which form part of o f the product safety and quality system are identified with a version number and issue date. This shall include a list of controlled documents indicating the last version number.

Clause 3.2.1: higher The site shall have a document control procedure to ensure that all key documents which form part of the product safety and quality system are effectively managed. This shall include:

       

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a list of all controlled documents indicating the latest version number the method for the identification and authorisation of controlled documents a record of the reason for any changes or amendments to documents the system for replacement of existing documents when these are updated.

Documents which are in electronic form shall be suitably protected to prevent pr event loss or malicious intervention.

Interpretation  Applies at both foundation and higher levels 

Documents need to be identified by, for example, an identification number, issue date, version number, author and approval authority. Documents should show page numbers and the total number of pages (for example, page 4 of 7). A method for rescinding previous versions, in part p art or in whole, should also  be in place.  Note that the system for document control extends extends to the issuing of external documents, such as copies of standards (including the Global Standard), customer specifications and legal information. Examples of documents that need to be controlled include:

   product specifications    procedures, such as those for supplier approval, or for selecting reference samples samples   work instructions   forms   records   other similar documents.

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3.3

Record completion and maintenance

Statement State ment of int ent The site shall maintain original, accurate, timely and legible records to demonstrate the effective control of product safety, legality and quality.

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Interpretation Senior management is responsible for the procedures relating to overall control of records. It must ensure that the data is properly collected, used, stored, reviewed and maintained.

Example Loss of records often occurs as a result of wider changes in a company. A textile company is about to move to new premises and the managing director decides to have a clear-out. Many old record r ecord boxes are sent for disposal by the site services manager, without considering their the ir content. The company installs a new computer system in its new premises. Unfortunately, Unfort unately, some of the record files use old software no longer compatible with the new system. Important records are lost by both actions. This would result in a non-conformity. It highlights the importance of management commitment to, and understanding of, the requirements of the Standard.

Clause 3.3.1 Records shall be maintained in good condition and retrievable. Any alterations to records shall be authorised and justification for alteration shall be recorded. Where records are in electronic form these shall be suitably backed up to prevent loss.

Interpretation Records are documents that contain evidence about past effects. They provide information to act upon and data to help with continuous improvement. There should be a clear understanding of why records are to be kept and what purpose the information will serve. In order to be useful, they must be legible and genuine. It is also essential that they are signed, dated and authorised auth orised so that the person making the record can be identified and consulted as necessary. Records relating to the safety, legality or quality of the products must be kept securely s ecurely and in good condition so that they can be consulted if necessary. There is no n o point recording every detail if, when needed, the records are found to have been lost, destroyed or damaged. Records are documented information about measurements or events. Examples include:

     

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a signed checklist to show each time pest control stations have hav e been checked a control chart of tests done to check the strength of a seam the product release form from a goods-in department showing when each product was signed for release documented evidence of employee training.

There will always be occasions when mistakes are made and records need to be amended. Such amendments must be clear and identified identified –   –  for  for example, by simply crossing out a result, recording the correct one and initialling the change. If appropriate, a brief reason for the change can also be i ncluded. The use of pencil (which can be erased) and correction fluid (which obscures the original) is not acceptable for records. Records that store results electronically, whether by manual or automatic  processes, should have suitable security systems to prevent unauthorised changes. Auditors will ask for a demonstration of this. Records must be true observations of the event at the time and should not be completed after, or even  before, the event. Data can be backed up in many different ways such as by having a cloud server ser ver or using a daily, weekly or monthly back-up to a disc or tape from a mainframe server; usually these are kept off site.

Examples An operator on a line producing fabric conditioner has a record sheet on which to enter the results r esults of half-hourly pH checks. auditor notesthough that theonly operator has pre-initialled pre -initialled column used to authorise results for the The whole day, even two readings have beenthe taken.

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This is a non-conformity and also may encourage the auditor to investigate whe ther similar methods are used by others.

An auditor is shown a data logger attached to a viscosity gauge in the same factory. The auditor asks the operator about an unusual result. The operator says that it must have been a ‘rogue’ result, and deletes it.  A non-conformity would be raised raised as the record was changed with no evidence or aut authorisation. horisation.

A factory has a record of all knives, to whom they have been distributed, and when. The records also include evidence that all broken parts of a knife are returned before a new one is issued. The record is signed by the distributor and receiver of the knives. This is a satisfactory record and acceptable to the auditor.

Clause 3.3.2 Records shall be retained for a defined minimum period with consideration given to:

     

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legal requirements the shelf life of the product customer requirements.

Interpretation The length of time for which a record needs to be kept (known as the retention period) depends on a number of criteria:

 

Legal requirements in the country/regions of sale Some countries have minimum periods, especially related to product liability laws.   Customer requirements Some customers demand a minimum period. For example, baby diapers/nappies are stamped with manufacturing date and, in some countries, an expiry date.   Product lifetime This is a reasonable approach but may be difficult to determine deter mine in practice. An estimation of the lifespan of a product should be part of a risk assessment.   Time for any effects to have been realised   For some products, this is simple. For example, example, once a piece of kitchen paper has been used, there is not likely to be any further effect, but for some  products, particularly chemical products with with potential or even unknown long-term effects, this can be very difficult. For example, some of the chemicals previously used in hair dyes are no longer acceptable. In such situations, it is recommended that industry best practice is consulted, or records are kept for as long as possible.

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3.4

Internal audit

Statement State ment of int ent The company shall be able to demonstrate that it verifies the effectiveness of the t he product safety and quality requirements implemented from the Global Standard for Consumer Products.

Interpretation It is important to check periodically that any system is functioning and working as expected. This is why internal audits are necessary and crucial in providing evidence that the site is committed to its safety and quality goals. The BRC has published a separate guideline, Internal Auditing, which may be useful for those requiring more information.

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Clause Cla use 3.4.1: 3.4.1: fo undation The internal audit shall consist of a scheduled programme of recorded inspections by trained staff to ensure that the factory environment and processing equipment is maintained in a suitable condition for  production of safe and legal product against against GMP guidelines.

Interpretation The internal audit schedule should be prepared in advance so that different areas or activities are scheduled throughout the year. A single internal audit of all areas on a single day is not suf sufficient ficient to cover the full requirements of an internal audit programme as it will not provide the depth of assessment or level of confidence required. Guidance on the internal audit process, as well as an example of an internal audit plan, is provided in the BRC’s best-practice best-practice guideline, Internal Audit (Issue 2). The plan includes areas that need auditing along with a proposed schedule for completion. The example also highlights that the frequency of internal audits may vary; activities in key areas such as hygiene, good manufacturing practice, foreign  body risks and critical control points (CCPs) need to be audited audited more frequently than those in some other areas. How often an area is audited may be influenced by risk, known issues within the company, co mpany, best  practice or customer requirements. However, However, all activities should be covered at least once a year. year. The clause requires that documented inspections are undertaken to investigate any contamination risk from the equipment or building structure, and takes account of areas such as overhead beams, ceiling fittings, void areas, equipment contact surfaces and areas where dirt might accumulate and could easily  be missed from routine cleaning cycles. The Standard does not specify a frequency for such inspections; this would depend on the site structure as well as the types of product being produced. The auditor is likely to ask for a justification of the frequency chosen if they have doubts as to the effectiveness of the inspections. A record of inspections should be kept. Actions that are said to have been completed should be verified to prove that they have been done and that they successfully address the non-conformity. non -conformity. It is essential that audits and follow-up actions are recorded clearly and completely. If matters are not recorded, r ecorded, it is not possible for an auditor to verify that the work has been done, nor for the site to refer to iss issues ues at a later date.

Clause 3.4.1: higher There shall be a scheduled programme of internal audits throughout the year with a scope which covers the implementation of the process risk assessment, GMP and documented procedures to achieve this standard. The scope and frequency of the audits shall be established in relation to the risks ris ks associated with the activity and previous audit performance.

Interpretation The Standard requires that internal audits are scheduled and the scopes defined. This ensures that aspects of the Standard do not get missed or glossed over and that, over a 12 12-month -month period, all departments and processes are covered.

Examples A new quality manager is appointed in an electric toothbrush factory and enthusiastically sets up an ambitious and frequent internal audit programme. Several months into the job, the quality manager realises the programme is unrealistic and cuts back because some of the audits are not necessary. Unfortunately the change is not documented, nor is a new schedule devised. When the auditor reviews the audits they discover that some aspects have been audited many times but others have not been covered at all. This results in two non-conformities: one because b ecause the documented audit procedure has not been  followed, and two because aspects aspects of the Standard have not been audited.

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Blades on a cutting machine have to be checked and cleaned or replaced weekly. An internal audit is scheduled at six-monthly intervals to confirm that the records have been correctly completed. It shows, through interview, that the operative has been following the procedure. At the same time, the operative’s training records are examined examined to demonstrate their competence. The auditor records that the operative had the correct version of the procedure, followed it and was adequately trained. The auditor also notes that the records of machine maintenance had been completed correctly since the last audit. This is satisfactory.

Clause 3.4.2: higher Internal audits shall be carried out by appropriately trained, competent auditors. Auditors shall be independent (i.e. not audit their own work). Interpretation Auditors are expected to have received training (internal or external) on how to audit and what the  process entails. They will also need to know how how to report findings. Many skills of internal auditing do not depend on technical knowledge of the process, but sometimes this will be required. It can be difficult to source so urce such knowledge from someone who is independent of the operation being audited. Internal auditors should never audit their own work, since it will not be  possible to remain objective, or the audit will will not be viewed as objective. If this situation arises, then the person responsible for internal auditing may need to seek external independent resources to assist with the audit.

Example A small company produces household cleaning materials and needs to carry out an internal audit of the use of dangerous chemicals. This is carried out by the company engineer who finds that assessments assess ments have been made and a procedure is in place, but still feels unable to evaluate whether the justifications for using dangerous chemicals are adequate. There are several ways to handle this situation. The internal auditor should first check whether the evaluation has been validated by another competent person. If not, no t, the auditor could contact the trade association for further information, seek help from another staff member or possibly employ an external resource for this matter. The company engineer should not just accept the findings and hope that they are correct.

A company has a documented procedure for how to calibrate a balance before use. An internal auditor can check that an employee is following the requirements even if they do not actually know how to use the balance themselves. This is satisfactory.

Clause Cla use 3.4.3: 3.4.3: fo undation The inspection programme shall be fully implemented, and the results shall be reported to a suitable  person. Records of any non-conformities and corrective actions actions shall be available within agreed timescales and completion verified.

Clause 3.4.3: higher The internal audit programme shall be fully implemented and tracked. Internal audit reports shall s hall identify conformity as well as non-conformity and the results shall be reported to the personnel responsible for the activity audited. Corrective actions and timescales for their implementation shall be agreed and completion of the actions verified.

Interpretation The audit programme may be scheduled according to department, procedures or by sections of the standard. Either way, the system needs to be divided into manageable elements, then the trained independent auditors can be assigned to each element at appropriate intervals and the frequency

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determined according to risk. The system needs to be kept up to date according to the schedule. The results of the internal audit must demonstrate the positive points –  points  –  for  for example, those areas that work well –  well  –  although  although any actions required need to be agreed. The timescale for implementation should ensure that corrections are actually done and it should be clear who is responsible. It sets an expectation that can be reviewed against the actual result achieved. A record of audits should be kept. Actions that are said to have been completed should be verified to check that they have been done and that they successfully address the non-conformity. It is essential that audits and follow-up actions are recorded clearly and completely. If matters are not recorded, it is not possible for an auditor to verify that the work has been done, nor for the site to refer to iss issues ues at a later date.

Examples A company has an audit schedule which it keeps to. Audit reports are available, but they only list the non-conformities found. This results in a non-conformity and highlights the need for better training or procedures for audit reporting.  It is not possible to judge from the reports reports whether all aspe aspects cts have been considered during the audits, since positive aspects are not included in the report.

Following an internal audit, the site supervisor of a cosmetics factory has agreed a greed to improve cleaning in the packing area. They revise the cleaning schedule for walls and windows and document a new  procedure within a month. The internal internal audit subsequently contains an update note that that the action has  been delayed by a week week due to illness. The action was implemented a week week later but was found to be satisfactory. This would be acceptable. Although the deadline was missed, it was carried through in a reasonable  period and the reason for the delay was clear.

3.5

Supplier approval and performance monitoring

3.5.1

Management of suppliers of raw materials, components and packaging

Statement State ment of int ent The site shall have an effective supplier approval and monitoring system to ensure that any potential risks from raw materials, components or packaging to the safety, legality and quality of the final  product are understood and managed. managed.

Interpretation This clause sets out the requirement for sites to control their purchasing of anything that affects product safety, legality and quality. This includes not only raw materials but also components, subcontracted work, packaging materials, instruments, machinery and possibly processing aids if they can result in unsafe products being produced. It is essential that potential suppliers are evaluated.

Clause 3.5.1.1: foundation The site shall have a defined and implemented process for supplier approval, including a list of approved suppliers of raw materials, components and packaging impacting product safety, legality or quality. The approval of these suppliers shall be based on at least one or a combination of the following:

 

supplier questionnaire

     

certificate of analysis supplier audits supplier certification with a scope covering the products supplied

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historical evidence of good supply.

Interpretation It is essential that sites work with reliable suppliers s uppliers and that they know the basis on o n which they have chosen their suppliers. It is increasingly necessary in some product sectors to be assured that suppliers not only supply to specification but also maintain adequate traceability systems. The precise methods of supplier approval are not prescribed and may vary depending on the items to be  purchased the level of associated risk, procedure as well as as is therequired. supplier’s experience ofout working with the site. Whicheverand method is used, a documented This should set the procedures pr ocedures to  be followed, whether a risk assessment has been conducted, conducted, the records to be kept, the criteria for approval and how exceptions are to be handled.

Clause 3.5.1.1 3.5.1.1:: h igh er The site shall have a documented procedure for supplier approval, including a list of approved suppliers for products, materials and services impacting product safety, legality or quality. The approval of these suppliers shall be based on at least one or a combination of the following:

       

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supplier questionnaire certificate of analysis supplier audits supplier certification with a scope covering the products supplied.

Interpretation Every new supplier of goods (or services) that could affect the safety and quality of the final product needs to be formally evaluated to ensure that it is able to reliably deliver the specified products. Sites can either have a formal documented supplier-approval system and checklist, or adopt a case-by-case approach. Either is satisfactory provided the key issues are addressed and suppliers are reviewed at intervals to ensure that they continue to meet the criteria used for their initial approval and that their  products meet requirements. This performance review should include an assessment of how complaints are handled, their the ir customer service in case of problems, and the actual supply record.

Clause 3.5.1.2 3.5.1.2:: h igh er Documented procedures shall be established which include clear criteria for ongoing assessment of the standards of performance required. Ongoing assessment may employ one or more of the following or other acceptable methods:

       

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in-house checks certificate of conformity supplier audits traceability checks.

Records of this monitoring shall be retained with consideration given to legal requirements, product shelf life and customer requirements.

Example A company is purchasing paint with which to decorate baby cots. It has approved the supplier based on on the fact that the supplier has current ISO 9000 certification. The auditor would not accept this without further research. Unless the factory is carrying out its own testing on each batch of paint supplied, the approval process is unlikely to be sufficient. It would be more usual to insist that batches of paint are delivered with certificates of analysis.

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Clause 3.5.1.3 3.5.1.3:: h igh er Documented procedures shall define how exceptions are handled; for example, the use of products where audit or monitoring has not been undertaken. Based on a batch or delivery basis, the procedure may involve the assessment of certificates of analysis.

Interpretation Only approved suppliers should be used, but as an exception a site may find that t hat it either requires materials at short notice, or is not in a position po sition to wait for materials; for example, when an approved supplier has unexpected problems with delivery. If such a situation might occur, the site must have a  procedure in place to determine determine how to handle it and in what circumstances circumstances an unapproved supplier can  be used. Any instances when an unapproved unapproved supplier is used must be documented.

Example A cosmetics company sources its perfumes from two approved suppliers but finds that t hat both are having trouble supplying a particular fragrance. Rather than stop production it sources from a third company, following its procedure for unapproved suppliers. This requires req uires the supplying company to fill in a self self-assessment evaluation, for the batch of material to be tested before use and a small s mall trial run to be carried out.  An auditor would find this approach approach satisfactory.

3.5.2 materialsControl and acceptance of incoming raw materials, components and packaging Statement State ment of int ent  FUNDAMENTAL 

The company shall have an effective process to ensure that incoming raw materials, components and  packaging materials are suitable for use and do not adversely affect the safety, legality or quality of the finished product.

Interpretation Sites carry out internal product inspections at various points in production; pr oduction; this includes an inspection  programme for incoming components, subcontracted subcontracted work or home work. The requirements of the Standard mean that inspections are carried out on a defined and rational basis and that, in and any whether subsequent it can bewas seensufficient whether to thehighlight inspection parameter in question the investigation, sampling programme thechecked levels othe f defects subsequently detected. Further details of the requirements and technical details of inspection and sampling procedures are available in the international standard ISO 2859 Sampling Procedures for Inspections by Attributes. Other similar, commonly used standards include Mil Standard 105, ANSI Z1.4 and BS 6001.

Example A company is producing skin lotion; it has carried out an assessment and established that if the water quality is not controlled, there is a risk of product pr oduct contamination. A further assessment shows that both the incoming quality of the water and the cleanliness of interior pipes are important and that monitoring is required.  An auditor would look for the actions that have been put in p place lace as a result of this evaluation.

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Clause 3.5.2.1: foundation Raw materials, components and packaging shall be checked on arrival to ensure they conform to agreed specifications and any agreed acceptance criteria, e.g. certificates of analysis.

Interpretation It is vital that the correct raw materials and components are used for products. If the wrong materials are used, it is very unlikely that products can be corrected at a later stage s tage of production. This clause is therefore a fundamental requirement for all sites. Incoming materials and components can be controlled in a number of ways, depending on the situation. They may require testing, checking of certificates of analysis or conformity, visual inspection or other checks. It is usual that accepted product can be identified in some way to help traceability, and to prove that it has been through an acceptance procedure. Items and materials that are stored pending acceptance should be segregated so there is no possibility of their being confused with accepted products. Similarly, any rejected goods must be labelled and segregated.

Clause 3.5.2.1 3.5.2.1:: h igh er Raw materials, components and packaging shall have documented approval procedures to ensure they conform to agreed specifications and requirements, and documented positive batch release. Incoming goods, including materials returned to site from subcontractors (and home workers), shall be subject to a documented positive batch release procedure.

Interpretation It is vital that the correct raw materials and components are used for products. pr oducts. If the wrong materials are used, it is very unlikely that products can be corrected at a later stage s tage of production. This clause is therefore a fundamental requirement for all sites. Incoming materials and components can be controlled in a number of ways, depending on the situation. They may require testing, checking of certificates of analysis or conformity, visual inspection or other checks, which should be described in a documented procedure. The procedure should also specify the means of release of acceptable raw materials and components and any labelling or recording requirements. It is usual that accepted product can be identified in some way to help traceability, and to prove that it has been through an acceptance procedure. Items and materials which are stored pending acceptance should be segregated so there is no possibility of their being confused with accepted products. Similarly, any rejected goods must be labelled and segregated. Any materials likely to affect the safety, quality and legality of a product must have written approval  procedures. It is a requirement that a positive release system is in place place –   –  i.e.  i.e. someone has to check the delivery and approve it. The rationale on which they make that decision should be clear. They might need to check that it is accompanied by a test report or they might need to physically ph ysically inspect it for size, colour or another parameter.

Example A company has been using a chemicals supplier for a long time with no problems. pr oblems. The supplier is supposed to supply surfactants with certificates of analysis but this is no longer checked, as there have never been any problems in the past. This is not acceptable. If the approval procedure states this should be checked as goods come in, then that should be done and documented. If this is inappropriate, the procedure should be reviewed, and a

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new approach documented and validated before changes are allowed. This would result in a non conformity.

Clause 3.5.2.2: foundation The company shall have a process to ensure that raw materials, components co mponents and packaging used by home workers (when used and if authorised by the customer) are approved.

Clause 3.5.2.2 3.5.2.2:: h igh er The company shall have a documented procedure to ensure that raw materials, components and  packaging used by home workers (when used used and if authorised by the customer) are approved.

Interpretation  Applies at both foundation and higher levels 

Work produced by home workers and the material they use must be controlled in the same way as work  produced on site, because the same safety or quality problems may occur. Home workers should have documented work instructions and any equipment they use must be subjected to maintenance  procedures and calibration as necessary. necessary. Home workers shall be made aware of any issues concerning concerning  product safety that are pertinent to their their work –  work  –  for  for example, avoiding foreign-body contamination or control of knives.

Clause 3.5.2.3: foundation The company shall have in place a process to ensure the authenticity of raw materials, components and  packaging to prevent fraud.

Clause 3.5.2.3 3.5.2.3:: h igh er The company shall have in place pla ce a documented procedure to ensure the authenticity of raw materials, components, packaging and documentation to prevent fraud.

Interpretation  Applies at both higher and foundation foundation levels 

This may necessitate some form of risk assessment, assess ment, such as Vulnerability Assessment Critical Control Point (VACCP) or Threat Assessment Critical Control Point (TACCP). Further information on risk assessments is given in the publicly available specification PAS 96:2014 (free of charge) and ISO/IEC 27001:2013 (ISO 27001) for information security management systems (ISMS). See also the Global Standard for Food Safety Issue 7: Understanding Vulnerability Assessment (UK). An assessment should be undertaken of what types of products are bought from where to determine whether there is a likelihood of substitution or fraud. This should be followed by actions such as enhanced supplier approvals, shortening the supply chain, mass balance exercise or extra audits of the t he supply chain. These actions may be supported by ‘horizon scanning’ to see if similar si milar products or materials have been affected.

Example  Applies at both foundation and higher levels 

The auditor is shown a project undertaken on manuka honey used in a face cream. The data and research showed this product to be vulnerable to substitution. Previously the site had bought this  product through an agent but since discovering discovering the issue has now approved a source from a broker who who  purchases directly from the farm in New Zealand. This would be accepted by the auditor.

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3.6

Specifications and technical files

Statement State ment of int ent A system shall be in place to manage specifications and technical data for raw materials, components and packaging materials.

Interpretation This clause covers two important but different needs:

   

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to have information about the materials and components used to make the product to keep all the technical information about the product itself.

It requires such information to be accurate and accessible within a reasonable period of time to those employees who need to use it. The Standard refers to the collection of product information as the technical file. In some product sectors there is a formal legal requirement to maintain a technical file. For example, in cosmetics it is referred to as the product information file (PIF); (P IF); this clause would also apply to such files. It does not mean that all the information has to be b e physically available on one file at all times, but it has to be available for each product; it can be assembled from different sources if necessary. In some countries and for some products (for example, electrical products in the EU) there is a legal requirement to produce such a file for the authorities within a defined ti mescale and in a language they can understand. It is therefore advisable to test and ensure that a technical file can be assembled from the available information if it is stored in a variety of locations. Some industry sectors call these collections of data dat a ‘product information packages’ or ‘job bags’. It does not matter what the information is called, as long as the content is correct. The site must be aware of what comprises its technical file, even if it is not in one place. This can be achieved, for example, by keeping a list of documents considered to form the file and their location.

Clause 3.6.1 Suitably detailed and accurate specifications shall be held for all ra raw w materials, components, packaging materials and finished products to ensure compliance with relevant safety, legislative, quality and customer requirements. The specifications shall be accessible to relevant staff and the company shall seek formal agreement of specifications with relevant parties.

Interpretation The correct materials and components are essential to the safety and quality of the product. If items are not clearly specified or bought on well-defined specifications, it is likely that they may be unsuitable for the purpose. The supplier cannot be responsible for supplying the wrong grade of material if it has not been correctly specified. The use of inadequate components and raw materials has caused many  product failures and safety issues. The specification must relate to the safety and quality and not just the performance perfor mance or physical characteristics of the product. If the site is manufacturing a customer’s own own-label -label product it is essential that there is a documented agreement regarding the specification of the finished product and the materials used.

Clause 3.6.2 A specification shall be available for each finished product and shall have been verified to ensure it is fit for purpose, meets customer requirements and is compliant with relevant safety and legislative requirements in the regions of intended sale. As a minimum, the specification may include the following, although this is not an exhaustive e xhaustive list:

   product name and description

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  composition    physical and/or chemical parameters parameters   assembly diagrams    packaging   labelling   intended shelf life   warnings   instructions for use.

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Examples A qualified, board-registered toxicologist has assessed a cosmetic for safety and produced a favourable report. The American company produces the material and ships it to another state. On the way, many of the bottles explode, contaminating products and leaving sharp plastic parts in the boxes. The toxicologist’s review was concerned with chemical safety. The site did not consider the physical  problems of overfilling bottles, or the build-up of pressure due to volatile components components within the specification.  Auditors will expect to see that all aspects have been ad addressed dressed by the ris riskk assessment.

Clause 3.6.3 Companies shall maintain the data in a technical file that is accessible to relevant staff containing all relevant data (or details of where such data is located) to ensure that products pro ducts meet the requirements of the specification and legislative and customer requirements. Relevant data may include:

   bill of materials   safety data sheets on all chemicals used where relevant to the safety, legality or quality o f the  product   risk assessment(s)   description of the conformity assessment procedure   test reports   inspection reports   list of the legislation and product standards with which the products are manufactured to comply    production control procedures and charts charts   approvals by any government body (if applicable)   declarations of conformity to legal requirements (if applicable)   self-inspection reports   corrective actions.

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Interpretation The technical file should be the source of all technical information about the product. The list provided in the Standard is only given to suggest the type of information infor mation required and is not exhaustive or compulsory. The actual information will depend on the type of product being produced and specific requirements in the regions of intended intende d sale. It should be treated as a ‘living’ document, updated when necessary by adding information as it becomes available. It is not something to set up at the beginning of production and then forget about. The auditor will expect to see evidence that the technical file is  being used.

3.7

Corrective and preventive action

Statement State ment of int ent  FUNDAMENTAL 

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The site shall be able to demonstrate that it uses the information from identified failures in the product safety and quality management system to make necessary corrections and prevent recurrence.

Interpretation There are many different ways in which non-conformities are discovered, both internal and external external –   –   for example:

 

Problems may be noticed internally by inspection, or quality assurance staff or o perators working

   

at the packing lines. Evidence may come via internal audits or routine reviews. Externally, non-conformities may be found during customer or third-party third -party audits, customer complaints, or actions of enforcement agencies.

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A site needs to have an efficient means of recording and investigating actual and potential nonconformities and reporting the findings. Even if, on investigation, there is no actual non -conformity, the investigation should still be recorded and it may help if the problem recurs. The Standard requires issues to be investigated in a ‘timely’ way. It does not define ‘timely’, but auditors would expect the site to have some requirements or guidelines in place that specify the timescales appropriate to the level of risk to the consumer.

Clause 3.7.1: foundation The company shall operate an effective system for the capture, recording and timely corrective actions of non-conformities or matters reported as possible non-conformities non -conformities critical to product safety, legality or quality.

Clause 3.7.1: higher The company shall operate an effective documented process for the capture, recording and timely investigation of non-conformities or matters reported as possible non-conformities critical to product safety, legality or quality.

Interpretation It is essential that sites have good systems in place to discover, record and investigate cases where their  products or procedures fall short of requirements. Sites failing to demonstrate that that they have a robust system will not be certified because they will not be able to give the auditor confidence in their ability to reliably place safe and legal products of agreed quality onto the market.

Clause 3.7.2: 3.7.2: higher An appropriate staff member shall be identified and assigned the responsibility and accountability account ability for each corrective action. This shall be documented.

Interpretation The Standard requires that a named individual is responsible for each identified corrective action. This has been found to be one of the most reliable ways of ensuring ens uring that actions are completed, and avoids any confusion. It does not mean that one person has to do all the work to correct the non-conformity; in many cases this is likely to be a team effort. The T he responsible person must, however, be documented and held accountable for the successful completion of the corrective action. Agreement of the actions is required, along with the timescale for implementation, to ensure that corrections actually get done and that it is clear who is responsible. It sets s ets an expectation and can be reviewed against the actual result achieved.

Example The site supervisor of a cosmetics factory has agreed to improve cleaning in the packing area. They revise the cleaning schedule for walls and windows and document a new procedure within a month.

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The internal audit subsequently contains an update note that the action has been delayed by a week due to illness. The action was implemented a week late but found to be satisfactory. This would be acceptable.  Although the deadline was missed, missed, it was carried carried out in a reasonable period and the reason for delay was clear.

Clause 3.7.3: foundation The company shall ensure that corrective actions prevent recurrence of the problem and shall monitor and record their completion.

Clause 3.7.3: higher The company shall ensure that effective corrective actions are taken to prevent recurrence of the  problem and shall monitor and record their their completion within an appropriate timescale. timescale.

Interpretation  Applies at both foundation and higher levels 

The Standard requires sites to investigate non-conformities in order to understand the root cause of the  problem and to put in place a sustainable sustainable solution that will prevent recurrence. This clause also requires the completed action to be carried out within an appropriate timescale, and to be recorded.

Example A wet-wipe manufacturer has found a non-conformity during an internal audit. The liquid solution pH was found to be not to specification which meant that there was a risk that the product would be vulnerable to mould growth. The problem was investigated and it was found that the mix setting had  been altered. The setting was corrected, checked checked and the non-conformity was signed off. The company is surprised to receive a non-conformity non -conformity for this, because everything had been properly documented. However, it did not address the part that prevents recurrence (root cause). The company did not try to find out why the setting had been changed and how this could be prevented, and therefore did not try to discover the root cause of the issue.

Clause 3.7.4: 3.7.4: higher The company shall review its processes at least annually and adopt preventive measures as they  become available.

Interpretation This clause is self-explanatory and requires an annual review to ensure that appropriate measures are adopted and new ideas taken up when appropriate. Sites would be expected to review the recurrence of similar issues and take action to investigate the causes, rather than just deal with issues as they occur. A summary of this data, any obvious trends and the effectiveness e ffectiveness of corrective actions taken as a result of it, should be part of the annual management review.

3.8

Control of non-conforming materials

Statement State ment of int ent The company shall ensure that non-conforming raw materials, packaging, components and products are clearly identified, labelled, quarantined, investigated and documented.

Interpretation Auditors will look for evidence of rejected packaging materials and how the rejected material is treated. Such material should be subject to the process for non-conforming non -conforming products and suitably

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recorded, segregated, disposed and reworked as necessary. It is vital that non-conforming products or materials cannot be mixed up with ‘good’ items. All nonnon - conforming raw materials, components,  products and packaging must be identified, identified, segregated and investigated. Non-conforming materials include any items that do not meet the stated specification and are not just those that are considered to give rise to a safety or legal problem.

Clause 3.8.1 Clear procedures for the control of non-conforming materials and products, including customer returns, shall be in place understoodbefore by all arelevant, personnel. shall include identification andand quarantining decisionauthorised has been made on theThese final disposition ofeffective the non conforming product by rejection, acceptance by concession or regrading for an alternative use.

Interpretation Procedures are required so that employees know what to do when a non-conforming non-confor ming material is discovered. If the actions required are not clearly stated, there may be a tendency to ignore the  problem. In some cases, a non-conforming material may be suitable for an alternative use –  use  –  for  for example, a  plasticiser unsuitable for children’s toys may be satisfactory for adult products. In other other cases, a material that falls slightly outside the agreed tolerance may still be usable without a major problem problem –   –   for example, a plastic master batch for a bucket manufacturer that is the wrong colour. If concessions are made to allow use, there must be a written procedure for this and all concessions documented and authorised. The reason for the existence of all non-conforming materials must be be investigated, ideally to prevent recurrence. Reduction in rework should inform a site’s KPIs and should  be reviewed as part of an internal internal audit. Procedures are also required to ensure that the subsequent use, return or disposal of non-conforming materials is handled and documented correctly. The product to be reworked must be subject to the methods and inspection or testing requirements that are in place for  production. A procedure for the disposal of unsafe or non-conforming material must be available and fully implemented. If unsafe or non-conforming products are allowed to be removed from a site without proper disposal, there is a risk of their reaching the consumer or being confused with good products. It is possible to use  products as ‘seconds’, provided there is no safety or legal issue and and that it is not a breach of customer requirements. Any such products must, however, be identified separately from ‘good’ products.  products.   In cases where it is warranted, auditors would expect to see that t hat disposal had been observed and signed off by a site representative or suitable independent third party, or carried out by an approved  professional contractor.

Example A company has rejected some plastic mouldings because the shape is incorrect. The T he items are segregated and sent to be ground up. The material is to be used as ‘regrind’ and added into the mix for another product at 8% of the total. Before the material is used, it is subjected to testing to ensure that the content of toxic elements is within the allowed limits. Pre-production Pre -production samples of the product are  prepared to ensure that the physical physical performance is appropriate. The material is also checked for homogeneity. All the procedures are documented. The auditor finds this acceptable. The auditor also reviews the records and test results for the products made with this material to ensure that they conform to specification.

3.9

Traceability

Statement State ment of int ent  FUNDAMENTAL 

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The site shall be able to trace all raw materials, components co mponents and packaging from its suppliers through all stages of processing and dispatch to its primary customers, and from the customer back to the supplier.

Interpretation It is worth remembering that a good traceability system makes sound business sense se nse and prevents or limits the scope of recalls or withdrawals of product. The best traceability systems incorporate a tool such as mass balance ‘for reconciling quantities of bought b ought in raw materials, components and packaging with finished product. Tosupplier this endand the from Global auditor will require to see not just j ust traceability from the customer to the theStandards supplier to the customer but also elsewhere a component or material has been used. Additionally, Global Standards auditors are required to carry out a full vertical audit which entails reviewing each and every step of the production process following the traceability of a product.

Clause 3.9.1 The site shall have a system in place which has the ability to trace and follow all raw materials, components and packaging materials from the supplier through all stages of processing and distribution distr ibution of the finished product, and vice versa, in a timely manner.

Interpretation This is a fundamental requirement because it is vital that stock sto ck can be traced in order to take appropriate action. There are two aspects to consider:

 

tracing back to suppliers’ raw materials and components used within the site to produce prod uce the  products   tracing forward finished products to the initial customers (i.e. retailers or wholesalers who have  purchased the items). In some cases, it will be a legal legal or customer requirement that products (for example, motor cars) can be further traced, perhaps even to the final consumer.

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It is worth remembering that a good traceability system usually makes sound business sense se nse and  prevents or limits the scope of unnecessary recalls or withdrawals withdrawals of product.

Example A company sources bottles for its children’s children’ s sunscreen products from three separate suppliers and  places them all in a single storage bin. It is subsequently subsequently informed by one supplier that one of the  batches of bottles did not pass a migration test. The company company has to withdraw all the production as it cannot identify which bottles have been used with which products. The company will receive a non-conformity non- conformity because it did not have a system in place. The company will have also wasted time and money recalling good products because it cannot distinguish them from bad ones.

Clause 3.9.2 Identification of lots/batches of raw materials, including packaging, processing aids, intermediate/semi processed products, part-used materials, rework, finished products and materials materials pending investigation, shall be sufficient to ensure traceability.

Interpretation Lots or batches are easier to define in some industries than t han others. For example, a curtain manufacturer making curtains from one roll of fabric might easily define that as a batch. On the other hand, a computer manufacturer assembling thousands of different parts, all from different batches or even different suppliers, may need a more sophisticated process. If each product has a serial number nu mber that uniquely identifies it, then it may become a batch of one. When products are made by a continuous  production technique, the site may need need to adopt an empirical approach and and define the batch in such a way as to limit the damage from any issues that occur –  occur  –  for  for example, by using a date or hour code. The T he auditor may ask the site to explain the rationale behind the selection of a batch.

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Clause 3.9.3: foundation Finished product shall be identified with a unique code such as a batch code applied to the product pr oduct or  packaging where legally required or specified by the customer. Procedures must be in place to trace a finished product back to the batch of raw materials or packaging used.

Clause 3.9.3: higher Finished product shall be identified with a unique code such as a batch code applied to the product pr oduct or  packaging. Documented procedures must be in place to trace a finished product back to the batch of raw materials or packaging used.

Clause 3.9.4 Subcontracted manufacture of products or components shall have prior customer approval and shall be traceable to a level appropriate to the risk.

Interpretation ‘Outer packaging’ is defined in the glossary of the Standard as the packaging visible when the product is released from the site. It is likely to be, for example, a cardboard box or multipack rather than an individual consumer product unit. The Standard does not require individual products to be marked unless this is a legal or customer requirement.

Clause 3.9.5 The system shall be tested to ensure traceability can be determined from raw-material raw -material receipt to finished product and vice versa. This shall occur at a predetermined frequency, at least annually, and results shall be retained. The time taken to complete the exercise shall be measured and recorded.

Clause 3.9.6 The need for extended traceability through the chain should be established on the basis of risk and any legal or specific customer requirements. Where required, extended traceability shall be implemented.

Interpretation The BRC publishes a best-practice best -practice guideline, Traceability, which gives more detail for those requiring further information. It includes examples of methods to be used and case studies. Therefore, this guideline does not address each subclause of section 3.9 in detail but offers further clarification on subclauses 3.9.2 and 3.9.4.

3.10

Complaint handling

Statement State ment of int ent The company shall operate an effective system for the capture, recording and investigation of product complaints at all levels of severity.

Interpretation This clause of the Standard covers customer complaints about safety, quality qualit y or legal issues. The system for recording complaints may be much wider and may include issues such as delivery, value and customer service. In this case, it must be possible to extract the complaints relevant to the scope of the Standard. Customer complaints, especially for larger producers, are likely to be received from a wide range of sources. A defined system and staff training are likely to be required r equired to ensure that an effective capture system exists and that complaints are well managed.

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For sites needing more guidance on complaint handling, the BRC produces a best-practice guideline, Complaint Handling.

Claus e 3.10.1 All complaints shall be recorded, investigated using root analysis and the results of the investigation i nvestigation recorded where sufficient information is provided. Actions appropriate to the seriousness and frequency of the problems identified shall be carried out to reduce the likelihood of recurrence.

Interpretation This clause simply requires that appropriate actions are carried out by suitably suitab ly trained staff. It should  be noted that the frequency of problems identified is mentioned; sites would therefore be expected to review the recurrence of similar issues and take action to investigate the causes rather than just j ust deal with issues as they occur. Corrective action plans must be clearly documented, giving details of the investigation and actions taken to prevent a recurrence. In some ways complaint handling is very similar to dealing with non -conformities. The site needs to ensure that complaints are captured and recorded effectively. Depending on the nature of the business, it is likely that complaints are received from a wide range of sources and delivered to a num number ber of  people –   people  –  for  for example, individual consumers calling customer service lines, comments made to sales  people during business development meetings, meetings, letters sent to the chief executive, and product returns returns from unsatisfactory deliveries. Whatever the source, the site needs a system to capture and collate the information. Many sites will record product safety and quality complaints along with a much wider range of issues. This is quite acceptable provided that quality and safety issues can be identified and are routed to an appropriate person for investigation in a timely manner. For sites of all sizes, it is important that a customer is made aware of information relevant to their products, whether the information is positive or whether there is a problem or issue. For higher-risk higher -risk products, where such information could relate to safety or legal matters, the Standard requires that individuals are responsible for customer communication. This does not mean that a person has to be employed solely for this task, or that the same person has to be responsible for all communication, but it does mean that a system has to be in  place, people have to be aware aware of their responsibilities and any communication has to be found found to be effective. In complex supply chains, customer complaints may be delegated to third parties such as agents or importers. In such cases, the allocation of responsibilities must be clear and documented in advance. It is important that problems do not arise because of the unclear division of responsibility, or because  people think that someone else is handling the issue. It is also important that the third party knows the extent of their authority when offering remedial actions or refunds. In these circumstances, clear communication with the provider of this service is essential to ensure that information infor mation is captured appropriately and that a management system is in place. The effectiveness of this system should be checked and reviewed. There are a number of ways to do this –  this  –  for  for example, follow-up calls or visits, customer surveys, reviewing complaints, logging customer contact and feedback –  feedback –  but  but the Standard is not prescriptive.

Claus e 3.10.2 The company shall have a process in place to respond in a timely manner to consumers and customers regarding complaints.

Interpretation Complaints are an important source of information concerning business performance and customer satisfaction. It is important that this information can be recorded accurately and that it is not hidden or lost because people are worried about the implications of reporting negative comments. Complaints

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should be seen as opportunities for improvement. It is a requirement of the Standard that the complaint data is analysed and used to drive continuous improvement. A summary of this data, any obvious trends and the effectiveness of corrective actions taken as a result of it, should be part of the annual management review.

Example A company has a procedure for logging complaints and a simple form on the company’s intranet site where all employees can record information. The system is explained to an employee as part of their initialand training. Each section responsible for reviewingtothe inputthe to the system on a monthly  basis a customer servicesmanager managerishas overall responsibility overall review complaints and follow up on any necessary actions. When complaints concern safety, quality or legality, they are coded so that the quality manager also receives r eceives the complaint immediately and can review the urgency of any action to be taken. An auditor reviews the complaints on the intranet system and selects one example. They follow the trail of the complaint to ensure that all parties have carried out the required actions and that the correct corr ect information has been logged. During this investigation, the auditor takes the opportunity to question staff about the system and finds it to be well understood and used. The auditor is satisfied with the process.

Clause 3.10.3 3.10.3:: hi gher Complaint data shall be analysed for significant trends. This analysis shall be made available to relevant staff.

3.11

Management of incidents, product withdrawal and product recall

Statement State ment of int ent The company shall have a plan and system in place to manage incidents effectively and enable the withdrawal and recall of products should this be required.

Interpretation A product recall system is a fundamental component of a company’s product safety management system. EU legislation stipulates an obligation to all sectors of the supply chain to ensure effective systems are in place to minimise safety risks to consumers. This risk must be controlle d by the introduction, implementation and maintenance of effective and efficient product recall processes. The BRC has developed Product Recall, a guideline that gives an insight into what is involved in a  product recall, as well as guidance guidance and advice on creating or improving product product recall processes.

Example A company produces a depilatory cream. It has a problem with complaints of rashes and ha s decided to carry out a recall. They identify the faulty batch and recall all products from 40 customer sites. si tes. The system details the requirements for the staff and the contact details of the responsible respons ible people in the  process. In addition, the procedure enables the rapid identification of the customers and sites involved so that contact can be made and accurate information given. The certification body is notified within 3 days of the decision. This would be deemed acceptable by the auditor.

Clause 3.11.1: foundation The site shall have a system in place to monitor issues iss ues which could result in the need to withdraw or recall products including consumer complaints, product rejections and feedback from customers. There should be a process in place to notify senior management of an incident or emergency that may affect the legality, safety and quality of a product.

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Clause 3.11.1 3.11.1:: hi gher The site shall determine and provide written or other guidance to relevant staff regarding the type of event that would constitute an incident or emergency situation that impacts product safety, legality or quality, and a documented reporting procedure shall be in place which shall include informing their customers in a timely manner.

Interpretation  Applies at both foundation and higher levels levels

A product recall is from the market place where the product is in the hands of or available to the consumer, whereas in a withdrawal the product is still within the distribution network net work and under the control of the site. An incident could be as a result of an issue recognised r ecognised internally or as a result of a customer or even a consumer complaint. For example:

     

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Someone has had an allergic reaction to the new hair dye developed. The bottles received at a store are leaking from the cap. A non-production glass jar was broken in the filling area.

Equally it could be as a result of a similar si milar product being recalled or withdrawn from sale. Any of these issues needs to be fully investigated and resolved to ensure that there is not a potential for a product recall.

Claus e 3.11.2 The site shall have a documented procedure in place to effectively manage product withdrawals and recalls. Procedures shall exist to ensure that customers are notified immediately i mmediately on issues of significance to the customer or consumer in terms of product safety, quality or legality.

Examples A company recalls a mascara because of potential Bacillus cereus, Staphylococcus epidermidis and Staphylococcus warneri contamination. It also instigates a voluntary recall of certain shampoo, shampoo , body lotion, conditioner and shower gel products due to microbial contamination from bacteria. Having received five reports regarding consumers who were seriously burned after applying a flammable, continuous-spray sun care product, a manufacturer voluntarily withdrew its products from US markets because they could cause the skin to catch fire if a person perso n came into contact with an ignition source before the product was completely dry.

Claus e 3.11.3 The documented product withdrawal and recall procedures shall include as a minimum:

     

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identification of key staff constituting the incident management team and their key responsibilities an up-to-date list of key contacts, with details of agencies providing advice and support a list of persons who can initiate a recall.

Clause 3.11.4 3.11.4:: hi gher The site shall have written technical and quality agreements in place with agents and distributors and other parties in the supply chain where these are necessary to ensure effective withdrawal/recall.

Interpretation The agreement should detail the traceability requirements and contact details in order to initiate an effective recall or withdrawal.

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Claus e 3.11.5 In the event of a product recall, the certification body issuing the current certificate and the appropriate enforcement authorities shall be informed in a timely manner. The company shall be aware of and adhere to any legal reporting obligations in the regions of sale.

Interpretation This part of the Standard ensures that there are adequate procedures in place should unsafe or illegal  products be distributed beyond the site. In Europe, the the term usually means the physical return of the  product either for replacement or repair. The systems a site has in place to deal with the issue should reflect the regions in which its products are available for sale. However, Ho wever, they should all include the need to contact the certification body which issued the BRC certificate. Product withdrawal refers to actions taken for products that have not reached the consumer, such as those in retailer stores, storage depots and distribution points. The BRC has produced a best-practice guideline, Product Recall, which may help those requiring more detail. Authorities such as the Consumer Product Safety Commission (CPSC) ( CPSC) in the US and the Directorate-General for Health and Consumer Affairs (DG Santé) in the EU also als o produce information and guidance. The reason for the requirement to inform the certification body of any recalls is so that it can investigate whether there is any need for a re-audit and whether the recall casts doubt on the certification. The BRC does not require any definite action to be triggered on its behalf and the certification body may feel that actions have been carried out in accordance with defined procedures and therefore no further work is needed. It is also courteous to inform the certification body in case its i ts audit is called iinto nto question following the recall.

Example A company discovers that one of its sun cream products contains a chemical that is not allowed in the country of sale even though it is acceptable in the home market. It immediately informs the th e US and European authorities and posts recall notices. It also informs its certification body, which seeks information as to the cause of the problem and how it has been addressed. The T he company has established that bought-in perfume contained the banned substance even though it had been supplied with a certificate of conformity. The company has reviewed and improved its supplier-approval supplier-app roval  policies and instigated additional test procedures. procedures. The certification body decides that the incident has been dealt with correctly and that there is no need to revisit or suspend the certification.

Claus e 3.11.6 Products which are to be disposed of on safety grounds, as the t he result of a recall or withdrawal or as substandard trademarked materials, shall be disposed of securely. This may b e delegated to a specialist in secure waste disposal. Records of such material destruction or disposal shall be maintained.

Interpretation It is vital that, having determined that a component, product or even product packaging is illegal, unsafe, or of a quality that requires it to be destroyed, it does not make its way back on to the market. Guidance could come from BS EN 15713:2009, which provides a framework of key conditions to be adhered to by companies who destroy confidential information on behalf of their customers. Checks as to whether a licensed waste disposal company could securely dispose of product might include:

 

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video surveillance

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   background checks on all employees employees   secure facility   chain-of-custody procedures   alarm-monitored facility.

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Example In the US, lead-painted toys fall under the category of products that would need to be destroyed or  properly disposed of, according to the Consumer Consumer Product Safety Commission. They cannot be exported for resale. Disposal is therefore determined as part of recall r ecall negotiations with the CPSC, in accordance with state and federal environmental laws.

Clause 3.11.7: foundation The product recall and withdrawal procedures shall be tested at least annually.

Clause 3.11.7 3.11.7:: hi gher The product recall and withdrawal procedures shall be regularly tested, at least annually, in a way that ensures their effective operation. Results of the test shall include timings of key activities and shall be retained. The company's senior management shall ensure that results of this test shall be used to implement improvements as necessary.

Interpretation This is not to be confused with the traceability test. Certainly the test requires that traceability is effective, but it needs a much wider-ranging evaluation. Product recalls can cost millions or even  billions of pounds, so this activity is worth practising rather like a fire drill to ensure that everyone everyone (including deputies) is well versed in the activity ,which it is hoped will never happen. A product recall system is a fundamental component of a company’s product safety management system. EU legislation stipulates an obligation to all sectors of the supply chain to ensure effective systems are in place to minimise safety risks to consumers. This risk must be controlled by the introduction, implementation and maintenance of effective and efficient product recall processes. Improvements from the test may include timings or ensuring that phone numbers are updated. The T he test should ensure that the system works even when the site is at its most vulnerable; for example, just  before or during a major holiday, or at a time when when senior management is away from the site.

Clause 3.11.8 3.11.8:: hi gher The company shall develop contingency planning for business continuity in the event of major incidents such as:

     

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disruption to key services (e.g. water, energy, staff availability) events such as flood, fire and natural disaster malicious contamination or sabotage.

Interpretation This requirement is in place to ensure that business processes continue if unexpected events occur. The Standard is concerned only that guidance is in place concerning product safety and legality, although a full business continuity plan is likely to cover a much wider scope of activities.

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4

Site standards

4.1

External standards

Statement State ment of int ent Sites used for manufacturing, storage or distribution shall be of suitable size, location, construction and design to facilitate maintenance, prevent contamination and enable the production of safe and legal  products.

Interpretation This part of the Standard is one of the most straightforward. It requires that sites s ites are fit for purpose,  both externally and internally, internally, and requires that operations are conducted in an orderly fashion so as not to jeopardise the safety or quality of the product. For many products, the external conditions around a site will have no effect, but there are some situations when they can have a substantial s ubstantial impact on the  products being manufactured. In all cases, cases, it is important to ensure that the site is of adequate size and construction to produce the stated products safely.

Example A company stores cardboard boxes in an outbuilding, in an area of high rodent population. This could have an impact on the products, but the company keeps the area around the outbuilding as clear as  possible and has good pest control. There is no evidence evidence of rats entering the building. The auditor considers that this is satisfactory and that practical steps have been taken. It is not necessary or cost-effective to move the store but the site should continue to monitor the situation.

Clause Cla use 4.1.1: 4.1.1: fo undation The site to be included in the audit shall be clearly defined, and shall be located and maintained so as to allow the production of safe and legal products. The external areas and surroundings shall be maintained in good order.

Interpretation The site needs to be well defined with boundaries clearly marked –  marked  –  partly  partly so that the auditor is clear about the premises to be audited, and partly so that proper consideration can be given to the t he state and suitability of the location. As part of the audit visit, the t he auditor will look around the exterior site to establish the suitability of the location, the possibility of contamination and any other potential  problems that may be caused by a lack of clarity about the responsibility for shared or communa communall areas. Auditors understand that conditions are not always ideal and that sites and their surroundings often develop over time. They will understand that some buildings may be old or that new methods have had to be accommodated in buildings for which they were not intended. The auditor will need to be satisfied that any shortcomings in this regard do not pose a risk to the safety and quality of the product.

Clause 4.1.1: higher The site to be included in the audit shall be clearly defined, and shall be located and maintained maintaine d so as to allow the production of safe and legal products. The external areas and surroundings shall be maintained in good order. A site plan shall be retained and readily available.

Example A company produces bath and shower gel products in a purpose-built unit. u nit. The auditor observes that  part of the site is not named on the factory plan, and establishes that this area has been sublet to a separate chemical formulation research company.

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Because the area is not clearly separate from the main operation, the auditor would want to determine that there is no risk to the production site from fro m the use or disposal of chemicals from the sublet s ublet unit. The auditor would investigate how the company controlled the sublet area, any areas of overlap, common services, etc., and ask to see copies of documented procedures, as well as observing the activities on the factory floor. Since it is probable that the company would not be able to control the activity of the sublet operation sufficiently, it is likely that the auditor would issue a non-conformity.

Clause 4.1.2: higher Consideration shall be given to local activities and the site environment and measures shall be taken to  prevent contamination. Where measures have been put into place to protect the site (from potential contaminants, flooding, floo ding, etc.), they shall be regularly reviewed in response to any changes.

Interpretation This clause requires a site to consider its external environment. In most cases there will be no concerns,  but if measures have to be taken the the site must demonstrate that it checks these measures and ensures that they are still adequate.

Example A cosmetics factory producing mouthwash is in a rural setting and initially the site was not surrounded s urrounded  by anything more than a few houses houses and open fields that were used for grazing horses and sheep. In recent years some of the land has been turned over to a pig farm far m and the rest to arable farming. The auditor would raise a non-conformity as the site has not taken any action regarding the changing environment and the potential for pesticides and odours contaminating the products.

4.2

Security

Statement State ment of int ent Security shall be maintained to prevent access of unauthorised persons to production and storage areas.

Clause 4.2.1 Access to the site by employees, contractors and visitors shall s hall be controlled and a visitor-reporting system shall be in place.

Interpretation Access to sites should be controlled in order to prevent any accidental or malicious damage to the  product or materials. Care should be taken that the system for site security securit y is maintained during shift work and any shutdown  periods.

Clause 4.2.2: foundation Contractors involved in maintenance or repair shall be qualified or supervised and a member of staff shall oversee their activities.

Clause 4.2.2: higher Contractors involved in maintenance or repair shall be qualified or supervised, and a nominated staff member shall be responsible for their activities with regard to potential effects on the safety, sa fety, legality or quality of products.

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Interpretation A large percentage of all incidents and accidents are as a direct result of contractor co ntractor activity on site. Contractors should be suitably qualified and supervised, when appropriate. Whether or not continual supervision is appropriate, a nominated staff member should be designated as responsible for any contractors on site and ensure that appropriate procedures are respected.

Example The maintenance manager of a factory producing washing-up liquid has arranged for the back flushing of the newly installed water treatment plant. This process involves the introduction of a strong saline solution to the plant thus reactivating the resin bed. The maintenance manager has failed to inform the quality manager or the production manager of the activity. During the operation a line QC check is conducted and it is discovered that the washing-up liquid is the wrong density. Further investigation reveals that during the back-flushing operation the main water feed to the line had not been isolated and as a result a full batch of product is wasted. The auditor would raise a non-conformity non -conformity against such activity.

4.3

Layout, product flow and segregation

Statement State ment of int ent  FUNDAMENTAL 

The factory layout, flow of processes and movement of personnel shall be adequate to prevent the risk of product contamination and mix-ups and to comply with relevant legislation.

Interpretation The layout of a plant is fundamental to an efficient production process.

Clause 4.3.1 The layout process flow of machinery and equipment shall be arranged to minimise the risk of product contamination and damage.

Interpretation This clause is far more important in some so me industries than others. It is especially relevant when the  product is likely to become contaminated contaminated or damaged by being placed placed in contact with other stages of  production. It is particularly likely to be relevant relevant to continuous-flow sites where dead space in pipes or  potential mixing with the wrong components components may give rise to non-compliant products. Any site should be able to produce a plan of its p rocess. The auditor can, to some extent, use this as a site guide. Care should be taken to include all relevant processes. This should cover not only the main  production area but also ancillary storage storage or mixing facilities, and their relationship with the main  process.

Example A company produces sachets of liquid laundry detergents. The product has to be adjusted to the right  pH at the end of the line. Any cross-contamination cross-contamination with earlier stages of mixing will result in a  potentially contaminated product. product. The factory is arranged so that the final stage of mixing is at the end of the production line and has an automatic check immediately prior to the form fill seal process, pr ocess, removing any possibility of cross-contamination. The auditor would find this satisfactory provided the automatic check is adequately calibrated and tested at suitable intervals.

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Clause 4.3.2 Premises shall allow sufficient working space and storage capacity to enable all operations to be carried out and, if necessary, in hygienic conditions. The necessary level of hygiene shall be maintained for each product.

Interpretation It is self-evident that if a site is too cramped, the quality of the operation is likely to suffer. Auditors will wish to evaluate the work pattern and discuss how peaks in demand are dealt with. It is essential that equipment is located with sufficient space to allow easy access for operating, opera ting, cleaning and maintenance.

Clause 4.3.3: 4.3.3: higher The location of facilities and services, including toilets, cleaning and catering facilities, shall be segregated and separated from production areas and shall not jeopardise the integrity of the product.

Interpretation This applies to products where it is important not to risk the product integrity by possible microbiological or chemical contamination caused by workers or their food and personal effects.

Example An auditor observes staff eating their lunch on a table situated adjacent to a production line. There T here is the potential for staff members to spill food into the product pr oduct being assembled. This is unsatisfactory and would result in a non-conformity. All staff facilities should be located so that  product contamination is not possible. possible.

Clause 4.3.4: foundation When critical to product safety, legality, quality or customer requirements, controls shall be in place to ensure that raw materials, work in progress, rework, waste materials, packaging, components and finished products of different specifications are not inadvertently mixed and are effectively segregated.

Clause 4.3.4: higher There shall be effective segregation to minimise the risk of product pr oduct cross-contamination taking into account the flow of product, nature of materials, equipment, personnel, waste, airflow, air quality and utilities. Documented control procedures shall be in place.

Interpretation It may be necessary to segregate a product for many different reasons –  reasons  –  for  for example, to prevent microbial contamination or to ensure that products for different geographical locations do not mix.

Example A factory is producing perfumed talcum powder on the same equipment as it uses to produce baby  powder which is unperfumed. The production schedule starts the week with the baby powder powder and ends the week with the perfumed powder. The perfume is injected through a separate system directly into the flow of powder. There are no additional recipe materials. At the weekend the equipment is cleaned out and an initial charge of unperfumed powder is put through the machine; this is monitored to ensure that there is no residual perfume, and retained to be added back into the first run of the perfumed  powder. Once the quality control control supervisor is certain that there is no smell, a sample is taken to the laboratory to verify the finding. If the laboratory determines that there is residual perfume , a further sample is taken and all prior production is added back to the first perfumed batch. If a second sample fails then the line is stopped and another full clean is i s carried out.

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The auditor would deem that this was sufficient if there was also evidence that tests had been carried out to ensure that the first containers of fragrance-free powder did not contain any traceable perfume.

Clause 4.3.5 Where materials or products require special handling procedures to be in place, these shall be maintained to ensure product safety, quality and legality are not compromised.

Interpretation It is essential that products are not accidentally mixed –  mixed  –  for  for example, when a product is legal in one country but not another, or where a product contains materials unsuitable for some consumers (such as when products are separated for older and younger children). It may also be necessary to separate raw materials or components carefully so that there is no chance of their being used in the t he wrong products; for example, making sure that paints containing toxic metals are separated from those that are suitable for use on children’s products, or separating products that contain fragrances from those that t hat do not.  not.   The Standard is not prescriptive about how separation is done, only that it is considered and carried out effectively if found to be necessary.

Clause 4.3.6 The company shall determine whether allergenic or sensitising materials are used and, if so, documented policies shall exist for the handling of such materials including:

   physical or time segregation from other products

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use of identified, dedicated equipment if necessary adequate labelling of final products.

Interpretation This clause relates to the specific cases of handling allergenic or sensitising materials. In these cases, careful handling is important for several reasons, including:

       

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to avoid cross-contamination of products to make sure that the correct warning labels are placed on the products with the potential allergens to ensure ingredients are not confused to enable good traceability of such materials.

It is also necessary to ensure that the subsequent use, return or disposal of non-co non-conforming nforming materials are handled and documented correctly. The product to be reworked must be subject to the methods and inspection or testing requirements that are in place for production. The auditor will assess whether the segregation is adequate.

Example A company is producing a fragranced liquid handwash that contains a number of allergenic compounds. There is a requirement for these chemicals to be listed on the product label. The company has a system for separating out products at the end of the packing line into a discrete area. The auditor finds this to be acceptable but wishes to establish how cross-contamination is avoided in the mixing area. The company needs to demonstrate a suitable cleaning and checking programme.

Clause 4.3.7 Materials and products requiring segregation (e.g. materials intended for different geographical regions) shall have documented control procedures in place to ensure that product integrity is maintained.

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Interpretation Care needs to be taken to ensure that products are not inadvertently mixed. In I n the case of Forest Stewardship Council (FSC) paper, for example, the chain of custody needs to be maintained. Segregation may be physical or by time, although clear identification is the important control. It is also necessary to ensure that the subsequent use, return or disposal of non-co non-conforming nforming materials is handled and documented correctly. The product to be reworked must be subject to the methods and inspection or testing requirements that are in place for production. The auditor will assess whether the segregation is reliable.

4.4

Building interiors

Statement State ment of int ent The interior of the site, buildings and facilities shall s hall be suitable for the intended purpose.

Interpretation Buildings should be adequate to allow products to be made safely and of the quality required. The exact requirements will change depending on product type. A site needs to consider which factors may affect its products and whether it has taken reasonable steps to avoid or control the risks from these factors, particularly with regard to appropriate cleaning measures.

Clause 4.4.1 The site shall be maintained to minimise potential for product pr oduct contamination The quality and finish of site buildings and facilities, including any pipework and drainage, shall be suitable for the intended  purpose with due regard to the risk to product safety, safety, legality and quality, and shall be maintained maintained to an appropriate standard. This shall include, as defined by the risk assessment: assess ment:        

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a clean, tidy and organised factory adequate lighting adequate ventilation walls, floors, windows, doors and ceilings maintained in a good condition to prevent foreign body risks suitable and sufficient removal of any by-products and contaminants.

Interpretation Judging whether a site is sufficiently clean, tidy and in good repair is subjective, but auditors will be considering the condition of the site with regard to the potential for any adverse effects on production. Auditors will expect to see a working environment rather than showcase conditions, but will raise non conformities for unnecessarily dirty or untidy sites as well as for unreasonably cramped or congested locations. A generally clean and tidy site, relative to the product group, may be seen as a reflection of management commitment and worker safety.

Clause 4.4.2 Suitable and sufficient lighting shall be provided for correct operation of processes, inspection of  products, and effective cleaning.

Interpretation In a textile site, for example, the exact quality and intensity of light may be specified and important i mportant for colour- and pattern-matching. At a site making plumbing fittings, on the other hand, as long as it is wel welll lit and operatives can see clearly to work, no further requirements would be necessary. As a guide, the auditor will want to understand the importance the site places on lighting crucial to the product and, at the very least, be reassured that eyestrain is avoided.

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Particular industries will have their own detailed requirements and the clauses in this section reflect the more stringent needs for sites making products with potential cleanliness issues or within particular environmental settings.

Clause 4.4.3 The site shall be assessed for any particular requirements relevant to the products pr oducts being produced, such as temperature, humidity and electrostatic discharge. Any identified requirements shall be adopted, calibrated, documented, monitored and regularly reviewed.

Interpretation An assessment should be made to first establish whether any control is needed. Many products are made satisfactorily in the ambient conditions of the location and do not need further control. Some  products, however, are susceptible to variations in conditions conditions and need to be produced in conditions where temperature and humidity are controlled. If so, the requirements must be met and compliance with these requirements monitored. The site should have contingency plans for any failures to meet the required conditions.

Examples A site manufactures a variety of household products including some aerosol products with a high alcohol content. The alcohol-containing products are produced in a separate part of the factory. At the entrance all personnel are required to undertake a static check and if they fail they are required to wear a wristband and attach themselves to an earthing cable. The area is enclosed and has been assessed for  possible ignition sources including lighting and mechanical mechanical devices.  An auditor in the UK would also also wish to see that the site has carried out an assessment assessment in accordance with The Dangerous Substances and Explosive Atmospheres Regulations 2002 (DSEAR) requirement (employers are required to control the risks to safety from fire, explosions and substances corrosive to metals) and may want to see the alcohol licence issued from HM Customs and Excise.

A factory produces toilet tissue. If the humidity is not controlled, it is difficult to prevent mould growth and/or there is a dust problem. The site has installed humidifiers in the production areas and the area is checked daily to confirm that a humidity of 50 – 60% 60% is achieved. The humidifiers spray a fine mist that t hat helps to keep the dust down. Provided the company can show that the level of control is sufficient to prevent mould growth, this action would be considered satisfactory.

Clause 4.4.4 Where water quality presents a risk to the final product it shall comply co mply with the required specification (as defined in the region of intended product sale), suitably treated to prevent contamination and regularly monitored.

Interpretation These requirements apply to sites producing goods that need to avoid microbiological contamination. A site would be expected to demonstrate how it controls the quality of water used on site, and its knowledge of the requirements for water quality specified for the product in the country of sale. Auditors would normally expect to see evidence of water sampling and testing for chemical and/or microbiological contamination done at appropriate frequencies.

4.5

Staff facilities

Statement State ment of int ent Staff facilities shall be sufficient to accommodate the required number of personnel, and shall be designed and operated to minimise the risk of product contamination. The facilities shall be maintained in a good and clean condition.

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Interpretation This clause focuses on staff facilities, from fro m the perspective of eliminating product contamination. There may be other requirements relating to the health, safety and wellbeing of employees but these are not  part of the scope of the Standard.

Clause 4.5.1 Staff facilities such as washrooms and break areas must be provided pro vided and maintained in a clean condition and segregated from production areas to prevent product contamination. Where a site provides food service the food preparation areas must be clean and fit for purpose and adequately segregated from production areas.

Interpretation The requirement is not for any specific design or type of facility but to ensure that product contamination is minimised. This generally means that break activities, such as eating, should be in a  place physically removed from any production or packing area.

Example A customer complaint shows that a customer has received part of a sandwich inside a package they have purchased containing washing powder. An investigation reveals that an operator on the packing line had been eating lunch in the area and mistakenly placed the food into the box. The auditor would look to see that procedures are now in place that do not allow for the eating of food near production areas, and that these procedures are effectively monitored  –  otherwise  otherwise a nonconformity would result.

Clause 4.5.2 Where smoking or use of electronic cigarettes is allowed under national law, it shall s hall only be permitted in designated controlled smoking areas which shall be isolated from production and storage areas and fitted with air extraction to the exterior of the building. Adequate arrangements for dealing with smokers’ waste shall also also be provided at smoking facilities, both inside buildings and at external locations.

Interpretation Smokers’ waste, such as cigarette ends, matches, ash, snuff and chewing tobacco, can become a source of product contamination and so must be controlled. External waste should also be controlled to  prevent its being transferred inside the site.

Clause 4.5.3 Storage facilities of sufficient size to accommodate all reasonable personal items shall be provided for all personnel who work in areas where they are unable to keep possessions pos sessions with them.

Interpretation If staff are not allowed to bring their possessions possessio ns with them into production areas, because of possible  product contamination, they must be provided provided with adequate and safe storage for their items. This is so that staff do not try to carry items with them for fear of their being lost, damaged or stolen. The Standard is not prescriptive on this matter and any solutions suitable to the size and complexity of the site are acceptable.

Clause 4.5.4: foundation Based on risk assessment, the site shall determine and provide workwear as required and make  provisions for changing areas for all personnel: staff, visitors and contractors.

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Clause 4.5.4: higher The site shall use risk assessment assess ment to determine where a change to workwear in different areas is required. Any required changing facilities shall be provided for all personnel: staff, visitors and contractors. Changing areas should be sited to allow direct access to the production, packing or storage areas without exposure to any external area. Where this is not possible, the site shall use the risk assessment to help determine the activities required to mitigate any risk. This procedure shall be be documented.

Interpretation  Applies to both foundation and higher levels This is intended to prevent general as well as microbiological contamination. Once staff have changed into their workwear they should be able to enter the production site without the risk of recontaminating r econtaminating it on their journey from the changing facilities. This is equally important for others (such as maintenance staff or visitors) entering the site. In some cases, the design of the site may not allow direct access to the production area from the changing facilities. If so, the person responsible for the q uality, safety and legality of the product must carry out an assessment to gauge the risk of contamination. It may be necessary to define a specific  procedure (or route) to reach the production production area. If the assessment reveals that it is not possible to reach the production area without a risk of contamination, then the facilities will need to be redesigned.

Clause 4.5.5 Suitable and sufficient hand-cleaning facilities shall be provided at access to production areas, and at other appropriate points within these areas, based on appropriate risk.

Interpretation The risk assessment should determine whether hand cleaning is required in order to protect the product from contamination due to contact from hands. This is more relevant after eating, drinking, smoking or visiting the toilet. Where hand cleaning is essential, facilities must be provided in washrooms and other appropriate  points, such as entrances. It is also a requirement that signs or notices are placed placed near the washing  points. These act as a reminder and should also contain information about how the cleaning shall be done. It is often appropriate to include pictures or diagrams rather than a lot of o f text.

4.6

Housekeeping and hygiene

Statement of int ent Statement  FUNDAMENTAL  Housekeeping and cleaning systems shall be in place which ensure appropriate standards of hygiene are maintained at all times and the risk of product contamination is minimised.

Interpretation  No matter what types of products are being made, made, a clean, tidy site prevents unnecessary unnecessary contamination and ensures that the work is carried out in an orderly fashion.

Example A site has installed a new paint storage section in a previously disused area. The cleaning protocol is modified to include more frequent cleaning, removal of any paint spillages using a proprietary specialist cleaner, and checking drain filters to ensure there are no blockages. The auditor observes the paint store, which appears clean and well organised, and is satisfied the  procedure is operating.

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Clause 4.6.1 Equipment, production and storage areas shall be maintained in a state of cleanliness appropriate to the operations undertaken. Cleaning practices shall be completed so as to minimise risk of contamination and records kept.

Interpretation  No matter what types of products are being made, a clean, clean, tidy site prevents unnecessary contamina contamination tion and ensures that the work is carried out in an orderly fashion. The cleaning carried out shall be effective and not cause any product contamination. Both routine and exceptional cleaning (such as that needed for new equipment, after a close-down or after maintenance) should be appropriate and of adequate frequency. The use of suitable tools, which do not in themselves cause contamination, should be considered –  considered  –  for  for example, not using cloths or mops that are prone to leave threads, or employing colour-coded materials and equipment for use in in different areas. Dedicated, colour-coded equipment can be used for certain areas; for example, red for toilets.

Example The auditor asks questions regarding the housekeeping and hygiene equipment and is shown to a cupboard under the stairs. The cleaner is called and they open the cupboard door to reveal the contents. Inside there are a number of cleaning chemicals and a book in which there is a m aterial safety data sheet (MSDS) for each one. The chemicals are not perfumed and are suitable for the cleaning tasks. The equipment is colour-coded as follows:

  red for toilets   yellow for offices    blue for production.

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The auditor notices a blue mop and a red mop together with the heads of the mops touching. The auditor will raise a non-conformity non- conformity as there is a possibility of cross-contamination from the mops.

Clause 4.6.2 Suitable cleaning chemicals shall be identified, clearly labelled and controlled to prevent the risk of  product contamination. Chemicals Chemicals shall not be decanted unless into properly labelled an and d identified containers. Adequate storage facilities shall be provided and sited so as not to compromise co mpromise the safety, legality and quality of the product.

Interpretation The chemicals used should be chosen carefully so as to leave no taint or smell. Cleaning materials often contain potentially dangerous chemicals which may become hazardous if mixed with o other ther materials. All chemicals used on site should be adequately labelled and securely stored. This clause is included here because the primary use of chemicals on many sites is for cleaning, but the requirements also apply to any other chemicals used, such as pest control chemicals, weed killers and machine lubricants. It is not good practice to decant chemicals into other containers, especially if the shapes are associated with other liquids (for example, decanting a colourless solvent into a ‘soft drink’ bottle). If liquids have to be decanted, they must be clearly labelled with as much of the original or iginal information as  possible, in particular any safety or warning information information and any instructions for use.

Example A small unlabelled plastic spray bottle is on top of a printing press. The bottle contains solvent to thin the ink on the press if it becomes sticky. The auditor will raise a minor non-conformity. The bottle should be labelled with the contents, warnings and instructions for use.

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Clause 4.6.3 If cleaning services are outsourced, the service providers shall have signed a contract which identifies the scope and frequency of the work, and records shall be maintained. A defined company representative shall be responsible for ensuring that the work is carried out o ut satisfactorily.

Interpretation It is recognised that the cleaning of sites is often carried out by a third-party company. This clause ensures that the responsibility for a clean, tidy site is not abdicated by the site management and that the cleaning company used is committed to following suitable methods at a defined frequency. The clause contains a requirement for a log book to be maintained. This can be done in any format for mat (for example, signed-off signed-off work sheets or computer entries) as long lo ng as the information is recorded, ‘signed’ and dated.

Clause 4.6.4: higher Documented cleaning procedures shall be in place, validated and maintained for the building, utilities,  plant and all equipment. Where Where more than basic cleaning is required, cleaning procedures shall include the following information as a minimum:

       

responsibility for cleaning item/area to be cleaned frequency of cleaning method of cleaning

   

cleaning materials to be used cleaning records and responsibility for verification.

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Cleaning and housekeeping shall be carried out by trained personnel in accordance with documented  procedures, and records shall be maintained. maintained.

Interpretation Specified cleaning procedures are needed; the Standard outlines the minimum details to be covered. Additional information should be added as necessary in order to define the cleaning adequately. Cleaning personnel should also be trained with regard to the cleaning practices. Training is likely to take the form of practical demonstrations as well as checks to ensure that the protocols pro tocols and procedures are understood. This requirement also applies to any temporary or third -party staff that may be used.

Clause 4.6.5: higher The standard of cleaning shall be appropriate to the product being manufactured and shall be verified and documented and, where relevant, agreed with the customer. Corrective actions shall be documented. Cleaning procedures shall be revalidated following building b uilding work, maintenance, changes to equipment or new product introduction.

Interpretation In areas where cleanliness is vital, the effectiveness of the cleaning must be confirmed. There are a number of ways to achieve this and the site would need to assess the most appropriate means for its own operation. Examples of controls might include:

       

swabbing to check microbiological cleanliness confirmation of times and temperature used during steam cleaning visual and or olfactory inspection verification that the surface is free from residue

 

audit of the full cleaning procedure.

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4.7

Waste and waste disposal

Statement State ment of int ent Waste disposal shall be managed in accordance with legal requirements and to prevent accumulation, mix-up, risk of contamination and the attraction of pests.

Interpretation Thisdoes clause is a general requirement a system to be in place. It does not define type the of system  but require it to prevent the usefor of unfit or defective defe ctive materials. Auditors will the observe  production or packaging site to identify any any possible areas where waste may be misused or is poorly controlled.

Clause 4.7.1 Waste disposal shall be managed in accordance with legal requirements and to prevent accumulation, mix-up, risk of contamination and the attraction of pests.

Interpretation Waste material allowed to accumulate in a site may be a source of product contamination, become confused with satisfactory products or materials, and present a risk r isk of materials being misused.

Example A company has left a number of drums of rejected plastic stabilising solution outside o utside the factory for disposal. An employee has been on holiday for a week and does not know they have be en rejected. Thinking they can be used, the employee takes the drums to the production area, without first checking with the supervisor. The site should have procedures in place to identify this error before the material is used. Normally the drums should be clearly labelled as rejected product. If no such procedures are in place, the company will receive a non-conformity as there is the possibility of an out-of-specification out -of-specification product being  produced.

Clause 4.7.2 Where legally necessary, waste shall be removed by identified, licensed contractors, and records of disposal shall be maintained by the site.

Interpretation There are a number of reasons why waste may need to be categorised and segregated. Examples include:

       

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disposal of toxic waste disposal of highly flammable waste segregation for recycling purposes, such as plastic or paper measurement of weight or volume of some waste, such as batteries.

Some countries have legal requirements covering the waste measures indicated above, as well as others. In some cases, particularly those concerning toxic waste, disposal may be carried out only by registered and licensed operators. If so, the site must demonstrate that appropriate contractors were identified and evaluated through the site’s supplier -approval -approval scheme. The site must also demonstrate that appropriate records are maintained and include information such as:

     

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identification of material disposed quantity (volume, weight, number as appropriate) type and number of containers

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date and time of disposal signature of waste contractor (or responsible staff member if in -house).

Clause 4.7.3: higher Waste materials shall be controlled, clearly labelled and where necessary quarantined to ensure that they are not reintroduced into non-waste production flows.

Interpretation If waste material is not separated from good stock it is likely to become confused. A variety of quarantine methods, appropriate to the site, can be used and may include:

     

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separate storage areas defined and colour-coded/fenced-floor areas separate bins or containers.

If unsafe or illegal products have been identified, they must be disposed of securely to ensure that they cannot re-enter the supply chain. The site may also have specific customer requirements for products pr oducts that do not meet their specifications. In such cases, disposal must be carried out securely and the disposal/destruction validated and recorded. This work is often subcontracted to specialists. These specialists must have been evaluated under the supplier-approval procedure. re-entered the supply chain shall be rigorously investigated. Any evidence that that ‘destroyed’ product has re-entered

Example A company has sent a lot of branded disposable rubber gloves for disposal d isposal as the finish does not meet the customer requirements and the customer has requested that they are destroyed. destro yed. A batch of rubber gloves is for sale on the internet, which appears to match the description of the ‘destroyed’ samples. An investigation reveals that an employee took a carton from the premises, because they thought it was wasteful to destroy them. A site would be expected to deal with this on a number of levels, and to review.

Clause 4.7.4: 4.7.4: higher External waste collection containers and compactors shall be managed in such a manner as to minimise risk to the product if necessary.

Interpretation This clause is self-explanatory and requires that the containers are managed so as not to present a risk to the product.

4.8

Pest control

Statement State ment of int ent The whole site shall have an effective preventive pest control programme in place to minimise the risk of pests. Sufficient resources shall be available to respond rapidly to any issues iss ues that occur, in order to  prevent risk to products.

Interpretation Sites need some form of pest control to ensure that products pr oducts are not damaged or contaminated. Even when the product itself is unlikely to be damaged by pests, customers may still have pest control requirements so as to avoid the problem of infestation in the warehouses or transport. There are many publications providing further detail on pest control, including the BRC best-practice guideline, Pest Control.

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Example A site manufactures facial tissues impregnated with balm. The audit has been scheduled for the two days immediately prior to a national holiday. The factory manager has requested that all of the factory/good manufacturing practice elements are undertaken on the first day of the audit with the  paperwork/office side being audited on the second second day. During the visit the auditor asks to review the  pest control system on site and is shown a risk assessment that determines an electronic system will suffice to deter any unwanted pests. Reading the data supplied by the manufacturer, the auditor learns that the system emits a sine wave that resonates in the t he heads of small mammals, therefore discouraging them from staying on site. On the second day the auditor asks to revisit the production area. They are informed infor med that all staff have gone home and the area is empty. Still the auditor asks to see something on the shop floor and is taken down to the production area. Upon entry to the area the manager switches on the electricity to the production hall. The auditor enquires if this switch includes the mains plugs, into which the pest control system is plugged, and is informed that it is. The auditor raises a non-conformity as the pest control device will be off for the duration of the holidays.

Clause 4.8.1 The pest control programme shall be based on a documented risk assessment which should include the  product, the material included, the location location and type of premises, the possible types of pest, and the  process. The pest control provider shall be a specialist or a trained employee. The pest control programme shall include a documented inspection schedule.

Interpretation The important factor is to identify the target pest. This T his will vary from region to region; in some countries lizards and snakes are prevalent, and in others, mammals. Additionally, some products attract specific pests that will require specialist treatment. In the rare cases where a site considers that no pest control is required, it must justify its reason for the decision and review it every year.  Note that a site is responsible for managing the risk from pests even even if it subcontracts the activity. Typically, the annual control programme for rodents in the UK would be eight technician visits and one field biologist visit.

Clause 4.8.2 The company shall either have a clearly defined contract with external contractors which reflects the activities of the site, or have trained staff. During each visit activity/action reports shall be completed. These should include observations of pests or evidence of pest activity and recommendations for action by the site.

Interpretation Pest control is often subcontracted to external companies, which may need to be licensed or o r approved  by the authorities. Where contractors are used, the the signed contract must clearly define the scope and and level of activity to be provided. If is handled in-house, in- house, responsible employees must have undergone formal training and have demonstrated their competence. The activity found and any actions undertaken must be recorded so that any trends can be reviewed. Trends may be seasonal, or there may be a particular ‘hot spot’ on the site.  site.  

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A nominated manager is required so that the th e site’s management team is aware of any issues.  issues.  

Clause 4.8.3 When necessary, materials or products shall be fumigated, and records of this process shall s hall be kept. Fumigated goods may not be supplied to customers without full professional safety clearance a nd correct clearance documentation. All fumigation operations shall be controlled by staff with appropriate professional qualifications and/or training.

Interpretation The fumigation certificate, in respect of international shipping of sea freight (also re ferred to as a pest control certificate), is the proof that any wooden packing materials used in international sea freight shipping, such as pallets, crates or wood, have been fumigated or sterilised prior to the international shipment. In general, manufacturers of wooden packaging must meet the International Standards for Phytosanitary Measures 15 (ISPM15), as this is the standard most commonly used around the world. If you are despatching goods to another country within the EU there are no additional controls or standards, other than the presumption that any packaging made from wood produced in EU member states automatically complies with European Community internal plant health regulations. Exporters to Portugal are encouraged to use ISPM15-compliant wood packaging to enable its subsequent reuse outside of Portugal. This is because of emergency measures against the spread of pine wood nematode present there. The US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) regulates  regulates   the importation of wood and wood products. APHIS requires wood and wood products to undergo certain phytosanitary procedures prior to importation in order to eliminate the risk of introducing non native pests and diseases into the United States.

Clause 4.8.4 Full material safety data sheets for all chemical pest control agents used shall be b e controlled, available to relevant staff at all times and kept in a designated place.

Interpretation The report should contain details of what chemicals were used in which trap. Additionally, MSDS should be readily available to the site; for example, in the case of accidental poisoning.

4.9

Product storage, dispatch and transport

Statement State ment of int ent Facilities for the storage and transportation of products shall be suitable for purpose and minimise the risk of product contamination, damage and malicious intervention.

Interpretation Products are at risk from contamination during storage and when they are being moved around a site or transported off site. Off-site transport is often outside the control of the production site but, where it has responsibility for such transport, it must not introduce hazards. The individual requirements listed in this clause are self-explanatory. Concerns to be considered include:

  storage temperature    protection from rain or dust   stacking limitations procedures –  manual  manual and via pallet truck, etc.   handling procedures –    cross-contamination of materials

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security.

Clause 4.9.1 All materials, work in progress and product shall be properly identified and protected during storage by appropriate packaging to protect the product from contamination.

Clause 4.9.2 Where storage of raw materials, components, packaging, intermediate or finished product is necessary it shall be maintained in good condition and be securely protected from contamination, deterioration and damage. All handling operations during storage shall be managed to prevent product damage.

Clause 4.9.3 Vehicles or containers used for transportation and dispatch of product shall be inspected prior to loading to ensure that they are fit for purpose. Records of inspection ins pection shall be maintained.

Clause 4.9.4: 4.9.4: higher Documented procedures to maintain product safety and quality during loading and transportation shall  be developed and implemented. implemented.

Clause 4.9.5 Where product is vulnerable to weather damage, vehicles and containers for transportation shall be loaded and unloaded so as to protect the product.

Clause 4.9.6 Where a third-party haulage contractor is used, all the requirements shall be defined within a contract contr act and effectively managed.

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5

Product inspection and testing

5.1

Product inspection and laboratory testing

Statement State ment of int ent  FUNDAMENTAL 

The company shall have a programme for product inspection and testing to control products during and after production to ensure that products are safe, legal and meet the quality specification.

Interpretation Inspection includes the measures aimed at checking, measuring, or testing of one or more product characteristics and to relate the results to the requirements in order to confirm compliance. Testing is generally carried out using a laboratory to verify product parameters. This clause addresses the general quality control testing and specific cases when testing of a product representative of overall production must be carried out because of legislation. The test laboratories are also often specified. Although this is a fundamental requirement, if a site is making simple, low-risk  products, testing may not be necessary. The site is required to consider consider this matter, document why no testing is needed and relate this to the product risk, if any. Once O nce this has been done, the remaining clauses of the section are not applicable. Sites should expect an auditor to challenge their decision and  be able to justify it.

Clause 5.1.1 There shall be a scheduled product-testing programme according to risk for each product or product group as defined in the specifications. This shall be based on information such as:

     

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the outcome of the product and process risk assessments any legal requirements for testing in the regions(s) of intended i ntended sale the site’s requirements for demonstrating the production of safe products.  

The methods, frequency and specified limits of testing shall be clearly defined.

Interpretation The testing programme must be established, taking account of the range of factors listed in the Standard. Usually the programme should be determined before production starts, although there may be occasions where the need for additional testing is determined at a later date –  date –  for  for example, as a result of complaints, in order to improve features, or to take account of the need to substitute one or more raw materials. It is good practice to ensure that products meet the requirements of defined product standards in the countries or regions of intended sale. For some products this will be a mandatory requirement but, even when the standards are voluntary, compliance is usually the most straightforward way to show that the  product meets the requirements of the intended intended market. Sites should note that some specifiers have their own product standards, which may contain additional requirements. A site is advised to check if this is the case and, if it is, to make sure that it or its testing organisation has copies of the most up-to-date requirements. The test programme must relate to all parts of in-process production and product where testing is required. It includes tests on raw materials, component parts and products during production as well as final products. The programme may include testing carried out by third-party third-part y laboratories as well as inhouse testing, if this is necessary. When raw materials are specified sp ecified to be supplied with test reports, this should also be documented as part of the programme.

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A test programme is not complete unless it details how and when samples are selected, by what criteria the results should be assessed, and who is responsible r esponsible for checking and accepting the results.

Example A company produces pepper mills made with plastic and metal parts. Its test tes t programme comprises the following:

 

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Polycarbonate bodies are purchased with requirement for a test certificate on each batch to show the product meets the safety of materials in contact with food requirements. The actual tests and test methods are defined and all tests must be carried out in a laboratory accredited to ISO 17025 for the defined methods. There is a procedure in place for checking certificates before accepting goods. The company has decided that it is foreseeable that these items will be placed in a dishwasher so it has conducted dishwashing tests to a defined product standard to check suitability. This test has  been carried out by a company company experienced in the testing but not accredited. accredited. The company carries out ‘stress‘stress -cracking’ tests on initial initi al samples to confirm that the design does not have inherent weaknesses, and on a random but defined basis. Quality assurance is responsible for testing and analysing results. In-process testing is carried out to ensure that the screws scre ws are assembled to the correct tor torque. que. There is an internal procedure which defines the method and equipment to be used for this check. Each E ach operator checks a sample hourly and records the result on a production pr oduction control chart. The chart has clearly defined action and warning limits and there is an established procedure for the operator. The final product is subject to a performance test to grind 50 g of pepper. The conditions and  procedure for this test are defined. The test is carried out by the the quality assurance department.

 

Every six months a sample of final production is sent se nt to an independent third-party accredited laboratory to check for compliance with legislation. The precise legislation is defined.   The factory has a procedure for use testing of the mills at home by volunteers, and records of the  performance are kept on a defined defined chart. The quality assurance manager reviews reviews this information.

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 An auditor would accept this as an appropriate test progr programme. amme. Auditors are eexperienced xperienced in the  product categories and may have specific comments to make make about any tests that are missing missing or inappropriate. Note that the test programme covers quality and performance issues as well as safety and legality.

Clause 5.1.2 The testing programme shall be implemented and records kept of all test results. Results which are outside the defined specification shall be reviewed promptly by an authorised competent person. The need for corrective action shall be assessed and documented, and any action carried out as necessary.

Interpretation The stages at which a product is tested depends on the product pr oduct type, and any legal and customer requirements. It is usually more cost-effective to carry out tests relating to design issues as early on in the process as possible, so that errors may be corrected before high costs are incurred. For many higher-risk higher-risk products, a ‘type test’ needs to be carried out by an approved third third-party -party laboratory. This is a test to ensure that the model is made in conformity with the appropriate legal requirements. Once the product passes passe s this test it is the site’s responsibility to ensure that the ongoing  production continues to match the tested tested sample. Even if there is no legal requirement for a ty type pe test, sites should ensure that the general production samples meet the same standards as tested products.  Note that a site needs to be cautious when when accepting testing of raw materials packaging packaging and components as an alternative to final-product testing. It may be that all individual components and materials are satisfactory, but that there is an interaction between them or the way they in which they are used, which means that the final product is unsafe. It is industry best practice to test the final  product randomly to ensure that the product going to the consumer is satisfactory.

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Example A company uses a solvent-based glue to assemble a product. The glue and the plastic materials being assembled have both been tested and comply with legal requirements and tthe he specification. When assembled, the solvent from the glue affects another component adjacent to the glued area, causing it to weaken and break under some conditions. Testing of the final product would have revealed this issue.

Clause 5.1.3 Where the company undertakes or subcontracts analyses which are critical to product safety or legality, the laboratory or subcontractors shall have gained recognised laboratory accreditation or operate in accordance with the requirements and principles of ISO/IEC 17025. Documented justification shall be available where accredited methods are not undertaken.

Interpretation There are many things to consider when deciding where testing is to be performed and who will carry it out. It is essential to use accredited laboratories only for tests critical to safety or legality that are not also validated by additional tests. For example, a strength test carried out on the site does do es not need to be accredited if some random samples are also sent to a third-party third -party laboratory for verification of the results. An accredited laboratory is one which has been audited by the appropriate national accreditation service to check that it operates in accordance with ISO 17025. There are other accreditation schemes in some countries but these generally follow the same principles. If a laboratory is working to an alternative scheme, this can be accepted provided p rovided it has been audited by a competent and independent third party and can show that it follows the requirements of ISO 17025. Sites should note the following important points about accreditation:

 

Each accredited laboratory has a scope of accreditation, which is publicly available. Only those tests listed on the scope are accredited.   A laboratory is unlikely to be accredited for all the tests it performs. pe rforms. This does not mean that it is  performing other test work to a lower standard but it may indicate that that it performs the testing less frequently, does not have exactly the right equipment or has not found accreditation to be cost effective. If in doubt, a site should ask the laboratory why it is not accredited for a particular test.   When an accredited laboratory is not available for some tests, the site wishing to test products pr oducts

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should confirm that its chosen laboratory is working to the principles pr inciples of ISO 17025. An auditor would ask for justification of the use of such a laborato ry if the test was key to safety or legality. The Standard is not prescriptive about this, as long as testing te sting is carried out competently and meets customer and legal requirements. The following should be considered when planning testing:

   

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Customers may have preferred or required test laboratories. Testing the final product in the country of origin may give faster f aster response times and make it easier to discuss results, but testing in the country of sale may be more acceptable to the customer. Some ‘type tests’ must be carried out by laboratories approved by the authorities. Even if capabilities exist in-house, it is sometimes useful to have independent verification of key results both as a benchmark and to reassure clients. Some test results are subject to interpretation and differing opinions. It can be useful to get more than one view on tests for important projects.

Sites should always be satisfied that testing is carried out by competent and trained staff.

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Clause 5.1.4 Procedures shall be in place to ensure reliability of test results, other than those critical to safety and legality. These shall include:

         

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use of recognised test methods and reference standards, where available documented testing procedures ensuring staff are suitably qualified and/or trained and competent to carry out the t he analysis required use of a system to verify the accuracy of test results res ults (e.g. ring or proficiency testing) use of appropriately calibrated and maintained equipment.

Interpretation It is essential that inaccurate results are not relied r elied on. It is also important that the test methods used are  precise, accurate and can meet meet the required detection limits for the substance being measured. Likewise, the correct level of discrimination must be possible. Part of the assessment to ISO 17025 is that the laboratory uses suitably validated test methods and has the right quality assurance procedures in place. Even when tests are being carried out by non -accredited entities, it is still important that test results r esults are accurate and robust. The Standard suggests a number of  possible ways to do this but the list is not exhaustive. For straightforward tests and measurements, measurements, very simple means may be available (for example, cross-checking a measurement with two different makes of measuring rule), but in other cases more complex work will be required. The advantage of using recognised test methods, published in national or international standards or similar documents, thathave the methods haveinalready been validated checked so own sites performance. can use them If with confidence andisjust a procedure place for ensuring the and quality of their a site wishes to use a method that is not recognised or is an in-house method, it will need to record and document the data justifying its validity.

Example A company uses a spring-loaded micrometer gauge to measure the thickness of plastic sandwich bags. The results are quoted to an accuracy of 0.001 mm but when checked the instrument is only accurate and calibrated to 0.01 mm.  Auditors will check the validity of results. In this case a non-conform non-conformity ity would result as the bag thickness has not been correctly checked.

Clause 5.1.5 Test and inspection results shall be reviewed regularly to identify trends. The significance of external laboratory results must be understood and acted upon accordingly. Appropriate actions shall be implemented promptly to address any unsatisfactory trends.

Interpretation The Standard requires that all results falling outside the defined specification are reviewed and actioned  by the responsible person. It is essential that such results are not ignored until until the annual review. It may  be appropriate, depending on the risk, to define a maximum length of time before reviewing reviewing the relevant procedures. It is also possible that a nominated deputy will need to be assigned to this task. Although this is not a specific requirement of the Standard, it is good practice for the responsible person to also review a selection of results that are in specification, since errors can be made with fal se pass results as well as failures. This review should form a part of the internal audit for the department responsible.

Clause 5.1.6: higher Where testing is submitted to third parties, the required testing shall s hall be clearly defined, including reference to the number, date and version of the test standard or method to be used.

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In cases where the company relies on the expertise of third-party third-par ty testing organisations to determine appropriate test requirements, the company shall ensure that the third party receives a clear written  briefing on the purpose of the test and that the the testing programme is formally agreed and documented. documented.

Interpretation A test programme should be defined as precisely as possible to remove ambiguities. For example, if the tests required are referenced by a product standard, the edition and section of that standard should be clearly stated. Sites often rely on their test houses to advise on the appropriate requirements, as test houses have more expertise in this area. This is quite acceptable but the site must ensure that the laboratory receives a written brief as to the requirements. Examples of this would be:

     

defining the countries of intended sale clarifying any testing which is not required –  required  –  for  for example, chemical testing of components indicating any user or usage information –  information  –  for example, the intended age range for children’s  products   explaining any limitations to the sample –  sample  –  for  for example, the final product will be in a different colour   the availability or unavailability of more samples –  samples –  so  so that the laboratory knows whether it has to do all tests on the product provided.

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The individual responsible for the testing programme and follow-up must be clearly identified.

5.2

Quantity control

Statement State ment of int ent The company shall operate a quantity control system which conforms to the legal requirements in i n the country where the product is sold and any additional customer requirements.

Interpretation For many product types, and in many countries, product quantity labelling is a legal requirement and the accuracy of information on this labelling is defined. The method and frequency of validating the information may also be legally set. Sites should be aware of, and abide by, any such requirements.

Example A company producing shoe polish for the European market labels the bottles with the net weight. The weight is described using the European average weight system. The company is obliged to check a defined number of products and to record that the average weights are within the defined acceptable ac ceptable tolerances. The auditor is likely to ask to see an example of the records and, if they are not available, a nonnon conformity would be raised.

Clause 5.2.1 Where necessary the company shall operate a quantity control system which conforms to legal requirements and/or specified customer requirements in the region where the product is available for sale. Documentary evidence shall be available on site to substantiate claims.

Interpretation Documentary evidence must be available on site to substantiate any quantity claims, such as net weight or average contents. These are governed by legislation such as the following:

   

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UK The Weights and Measures (Packaged Goods) Regulations 2006 USA  The Fair Packa Packaging ging and L Labeling abeling Act (FPLA)

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Canada Weights and Measures Act (RS 1985).

Clause 5.2.2 Where quantity checking is required, the frequency and methodology used based on valid sampling  plans shall meet the minimum requirements of any legislation governing quantity verification.

Interpretation In Europe, quantity is governed Council Directive 76/211/EEC 20 January 1976 onof the approximation of thechecking laws of the member by states relating to the making-up making -up byof weight or by volume certain pre-packaged products. In the UK it is enacted by the Weights and Measures (Packaged ( Packaged Goods) Regulations 2006. These regulations set out three rules with which packers and importers must comply:

   

The contents of the packages must not be less on average than the nominal quantity. The proportion of packages that are short of the stated quantity q uantity by more than a defined amount (the ‘tolerable negative error’) should be less than a specified level.  level.      No package should be short by twice twice the tolerable negative error.

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This statement is taken from the regulations themselves and it simply means that on average the average of the average must not be less than the nominal stated average. The regulations provide protection for consumers against short measures. Packers and importers must ensure that packaged goods are labelled with the quantity. The information must be visible, indelible, easy to read and not able to be damaged. In Canada the Consumer Packaging and Labelling Act and Regulations (RSC, 1985, c. C-38) apply. There are three principles that must be met to comply with the accuracy requirements of the Consumer Packaging and Labelling Act and Regulations:

 

The declared quantity on a package should accurately reflect the quantity being supplied, so the average net contents of the packages in a lot (batch) may not be less than the declared quantity.   The control over production should be such that the individual packages are within allowable tolerances. No more than 2.5% of the lot may have a negative error larger than the tolerance.   The number of packages that may have excessive negative errors is limited. li mited. Not more than one  package may contain less than twice twice the permitted tolerance. For example, if tolerance 1 (T1) is set at 5 g then a single unit with less than 10 g (T2) is illegal.

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5.3

Product sample control

Statement State ment of int ent The site shall ensure that procedures are in place for the selection, handling, storage, approval and use of reference samples taken from pre-production, subcontracted and finished production in accordance with customer requirements.

Interpretation It is helpful if a site keeps a sample sa mple of the product it intends to make. It may also be useful to keep subassemblies or components if there are a number of variations to the same sa me model. A site will often operate a final approved sample system with i ts customers. If so, a documented  procedure, in which samples are matched matched with first examples from the production line, should be in  place to ensure compliance with with customer requirements.

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Example A company makes a number of slight variations on a basically similar insect repellent spray. It decides to keep one complete sample and samples of various components of packaging to cover the entire range. For each style, a full specification and parts list (of ( of the aerosol components) are generated. The auditor will be satisfied with the approach provided that the company can demonstrate that all variants of assembly and manufacture are covered.

Clause 5.3.1: foundation Where legally required or specified by a customer, a reference sample of the product which has been be en approved by the customer or a representative of the agreed specification shall be retained. Interpretation Sites must determine how samples are to be selected, taking into account whether samples are kept at various stages before production –  production –  for  for example, example, first model, ‘looks like, works like’ model or final pre pre- production sample. They should also consider how samples samples are identified and selected, and who approves the sample. Any known differences between the sample and production should be noted. Customers often have their own requirements concerning samples. If so, a copy of their requirements should be available and the site procedure should detail how these requirements are implemented and reviewed. These are often referred to as ‘red’, ‘black’ or ‘gold’ sealed samples.  

Clause 5.3.1: higher Where legally required or specified by a customer, a sample of the product which has been approved  by the customer or a representative of the agreed specification shall be retained. The company shall document a process to identify, select and categorise reference samples. If customers have a defined system of sealed samples referring to different stages of sample approval, the customer’s procedure shall be documented and followed. followed.  

Interpretation Sites must have a written procedure to explain how samples are selected, which takes into account whether samples are kept at various stages before production –  production  –  for example, first model, ‘looks like, works like’ model and final pre-production pre -production sample. The procedure should include how samples are identified and selected, and who approves the sample. Any known differences between the sample and  production should be noted. Customers often have their own requirements concerning samples. If so, a copy of their requirements should be available and the site procedure should detail how these requirements are implemented and reviewed. These are sometimes referred to as ‘red’ or ‘bronze’ for pre - production  production samples or ‘green’ or ‘gold’ sealed samples for production.  production.  

Clause 5.3.2 Reference samples shall be stored and recorded in suitable environmental conditions to maintain their original status for a specified period.

Interpretation It is helpful if a site keeps a sample sa mple of the product it intends to make. It may also be useful to keep subassemblies of materials or components if there are a number of variations to the same product. A site will often operate a final approved sample system with its customers. custo mers. If so, a documented  procedure, in which samples are matched matched with first examples from the production line, should be in  place to ensure compliance with with customer requirements. Samples must be stored correctly; where an an investigation of a production issue is necessary, it will be unhelpful u nhelpful to find the reference sample rotten, faded or otherwise deteriorated.

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Requirements usually concern keeping products at the right temperature and/or humidity, but other aspects, such as light or freedom from magnetism, can be important in some so me cases. If the site does not know what storage conditions are suitable for its products, it should examine the samples at suitable intervals to determine whether any deterioration is noticeable. The site would be expected to understand the impact of storage conditions on the quality of stored  product, and apply suitable controls.

Example A company makes a number of slight variations on a basically similar washing -up liquid. It decides to keep one filled labelled bottle and samples of labels and manufactured liquid to cover the entire range. For each variant a recipe and bill of materials are generated. The auditor will be satisfied with the approach provided that the company can demonstrate that all issues of manufacture and filling are covered.

Clause 5.3.3: foundation A secure and tamper-evident system shall be in place for the storage of samples. A sample-tracking  process shall be in place and temporary removal of samples shall be managed.

Clause 5.3.3: higher A secure and tamper-evident system shall be in place for the storage stor age and tracking of samples, with access by authorised personnel. The removal and return of samples to storage shall be documented and authorised by a designated responsible person.

Interpretation Storage of sealed, pre- and post-production samples must be secure. If samples are not controlled it is not possible to say whether they have been substituted, left in unsuitable conditions, modified or or otherwise changed. Samples may also be removed or lost without secure storage. The level of such a system, and whether each product needs to be controlled or if it is sufficient to keep products in a locked room or cupboard with controlled entry, will depend on the type of product, the site and any customer requirements. The auditor will be looking for a system which gives confidence that the samples are reliable reflections of the pre-production model. This requirement is not intended to prevent samples being used or examined but to ensure that such events take place in a controlled way and with an appropriate procedure in operation.

Examples A small company is manufacturing disposable tableware products. It labels an example of each type with a numbered paper label and stores it in a locked cupboard. The label issue is controlled on a spread sheet detailing the product by label number. This is appropriate for the activity and an auditor would find it an acceptable approach.

A large factory manufactures baby nappies (diapers) with a variety of designs used on the elasticated waistbands for the high street retailers. The customer requires that each design is sealed in a bag with a tamper-proof seal and a log signed by the responsible person. If the t he bag is opened or the seal broken, broken , the factory has to contact the customer. The auditor would check that the process had been followed and look for evidence of missing samples or samples with damaged seals. If any evidence is found and the customer has not been informed, then a non-conformity would be raised.

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Clause 5.3.4 5.3.4 higher Documented procedures shall be in place to determine the retention time for samples. This should normally be the foreseeable lifetime of the product unless otherwise justified.

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6

Process control

6.1

Control of operations

Statement State ment of int ent  FUNDAMENTAL 

The site’s programme of process and quality controls to ensure the production of safe and legal  products of consistent quality shall be based on a risk assessment of the production process and the  potential for product contamination.

Interpretation This is a fundamental requirement because, without proper control of the sites process, safe products that are fit for purpose cannot be consistently achieved. There are various aspects to product safety, quality and legality:

  designing a product   selecting materials that are capable of resulting in a safe, quality product   ensuring that the manufacturing process is controlled so that this is achieved on a consistent basis    packaging products appropriately   ensuring that products contain suitable warnings and adequate instructions.

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The risk assessment should consider the whole programme from new product development through to dispatch. It should take into account all components, including packaging and the legal requirements for the country in which the product is to be sold.

6.1.1

Process risk assessment

Clause 6.1.1.1: foundation A hazard and risk analysis shall be carried out by a multi-disciplinary team or demonstrably competent manager. In the event of the site not having appropriate in-house knowledge, external expertise may be sought  but the day-to-day management of the system shall remain the responsibility of the site.

Clause 6.1.1.1 6.1.1.1:: h igh er A hazard and risk analysis shall be carried out by a multi -disciplinary team including representatives who are experienced in the particular activities undertaken by the site. The team members shall have knowledge of the hazard and risk analysis principles.

Interpretation  Applies at both foundation and higher levels 

For a comprehensive hazard and risk analysis to be established and maintained, it needs to be managed  by a nominated team with relevant relevant skills and experience. The number of team members members needs to be appropriate to the size and structure of the company, as the team will include representatives of each department with responsibility for the operation of the Standard. There will always be more than one  person, since a single person does not constitute a team. The team needs knowledge of the ty types pes of operations that are carried out at the site and the hazards these operations may present to the product. It is good practice to document the team members within the study, with a summary of their roles within theresponsibilities company. Membership the team needs to join be reviewed and, when necessary, updated (e.g. when job change orofpersonnel leave or the company).

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The team leader must be able to demonstrate competency and experience in using the HARA tools and  processes. This can be shown by:

   

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the quality of the plan documented evidence of the team leader’s qualification (e.g. successful completion of an industryindustry recognised risk assessment training course) demonstrable, extensive experience in implementing or training e.g. FMEA, HACCP, HARPC, nomograms, ISO 31000:2009 or AS/NZS 4360:2004.

Training records (see clause 7.1) need to demonstrate that adequate training has been given to all HARA team members. This may be achieved through either an external course or internal training. Senior management commitment (see clause 1.1) is required to support the HARA team. This may be demonstrated by the presence of senior management within the team, policy statements referring to HARA, or evidence within management review meetings that HARA issues are discussed and reviewed. The results of the HARA plan must be integrated into the product safety and quality management system.

Clause 6.1.1.2 6.1.1.2:: h igh er The person responsible for leading the hazard analysis shall receive sufficient training to be able to demonstrate competence in the understanding of hazard and risk management principles and their application. In the event of the site not having appropriate in-house knowledge, external expertise may be sought so ught  but the day-to-day management of the system shall remain the responsibility of the site.

Interpretation The team leader must be able to demonstrate competency and experience in using the HARA tools and  processes; this can be shown by:

   

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the quality of the plan documented evidence of the team leader’s qualification (e.g. successful completion of an industryindustry recognised risk assessment training course) demonstrable, extensive experience in implementing or training (e.g. FMEA, HACCP, HARPC, nomograms, ISO 31000:2009 or AS/NZS 4360:2004.

Training records (see clause 7.1) need to demonstrate that adequate training has been given to the HARA team leader. This may be achieved through either an external course or internal training.

Claus e 6.1.1.3 Where the hazard and risk analysis study has been undertaken centrally by the head office, accurate flow diagrams shall be available on site. It must be possible to demonstrate that a central hazard and risk analysis has been verified to meet the specific activities of the local operation. Verification activities include internal audits and complaints analysis.

Interpretation The flow diagram should include all of the inputs to the manufacturing process, process , from new product development to delivery.

Claus e 6.1.1.4 The scope of the hazard and risk analysis shall be defined in terms ter ms of the products and processes that are covered. The site shall establish precise process flow diagrams identifying each step in the production of the  products.

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Clause 6.1.1.5: foundation The site shall consider the potential product safety and quality issues which could occur at each process stage. Each potential issue shall be assessed to determine the level of risk and a nd suitable controls established to reduce or eliminate the risk.

Clause 6.1.1.5 6.1.1.5:: h igh er The site shall consider the potential product safety and quality issues which could occur at each process stage. This should include:

   physical or chemical product contamination contamination   microbiological contamination    product quality or safety issues as appropriate to the products manufactured. manufactured.

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The results of this assessment shall be documented.

Interpretation See the interpretation guidance given for clause 6.1.1.6: higher.

Clause 6.1.1.6 6.1.1.6:: h igh er An analysis of any identified issues shall be undertaken in order to decide which need to be controlled. The following should be considered:

     

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the likely occurrence of the issue the severity of the hazard (e.g. injurious to health, potential to cause, rejection or a product pr oduct recall) existing activities that effectively prevent or reduce the issue to acceptable limits.

Interpretation The site needs to identify the hazards that might be introduced if production pro duction is not adequately controlled. Hazards may be contamination issues or indeed poor controls leading to poor performance. They can be introduced in a number of ways, including:

   poor control of equipment settings   use of incorrect parameters, such as time or temperature   malfunctioning equipment   use of unsuitable raw materials.

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A site should carry out and document the assessment even if, subsequently, no additional hazards or control points are required.

Clause 6.1.1.7: foundation Where any significant product safety or quality issues are controlled by process monitoring the process  parameters shall be defined and records retained retained of checks of the process.

Clause 6.1.1.7 6.1.1.7:: h igh er For each issue which requires control, control points shall be reviewed r eviewed to identify those that are critical to prevent, eliminate or reduce a significant issue to acceptable limits.

Interpretation Process monitoring shall be established and adequately controlled to ensure products are produced within the required process specification.

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Which parts of the process (if any) need to be monitored is established following the assessment of  potential hazards and required process control. Monitoring may may be needed on the product itself (for example, pH or viscosity measurements) or the environmental conditions. In all cases the t he parameter to  be measured should be clearly defined defined as well as the acceptable tolerance, frequency frequency of measurement, measuring equipment and means of recording results. It is likely that auditors will ask to view some of these records, such as control charts filled in by operators, or automated electronic records.

Examples A cosmetics company has to control the temperature settings on the mixing machines to ensure a consistent mix with no lumps. The process is monitored by automatic temperature checks, visual examination, filtration and viscosity testing on site. All results are plotted on o n control charts with defined process limits. Photographs are available to compare acceptable results against rejects. This is a good example of the appropriate action being taken.

A household chemical company is manufacturing a toilet bleach. It has carried out a risk assessment and knows that if the product becomes contaminated with aluminium, aluminium hydroxide would form causing a hazard as the bottle could expand and leak or even explode. In order ord er to avoid this, the site measures the levels of contamination in the finished product.  By comparing the levels of contamination with the maximum ssafety afety level, the company knows whether the products easily satisfy requirements or are close to the limit. This may determine if the manufactured product is suitable for bottling.

A company is producing skin lotion; it has carried out an assessment and established that if the water quality is not controlled, there is a risk of product p roduct contamination. A further assessment shows that both the quality of the incoming water and the cleanliness of interior pipes are important and monitoring is required.  An auditor would look for the actions that have been put in place as a rresult esult of this evaluation.

Claus e 6.1.1.8 If there are identified critical control points (CCPs) where product safety and legality require control measures to be in place, then for each CCP the site shall:

   

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establish and validate critical limits establish a system to monitor control of the CCPs establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control establish procedures of validation and verification to confirm that the system syst em is working effectively, including auditing of the system establish appropriate documentation concerning all procedures and records.

Interpretation Critical control points (CCPs) are those points at which a parameter must be b e controlled and monitored in order to prevent critical problems occurring in the process. This is usually recognised as the last  point in the process which can be detected and and monitored and as a result there can be no subsequent step that will eliminate or reduce the effect. There would not normally nor mally be many of these points, since there are usually only a few really critical steps. Other points that need to be controlled, but are not critical to the product integrity, are called control points and may well be controlled through monitoring programmes. The monitoring at a CCP should be something that can be done and recorded in order to detect  problems. The control points should have defined defined monitoring and set limits outside of which action must be taken.

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A common misperception is that the complete product safety test represents a CCP; in fact this is unlikely to be the case. This is because a CCP reflects many different aspects of manufacturing, usually takes several days, and the result is only known when production is complete. Unless there is a positive release system in place, then this is not a control as the product could be sold before the safety test results are known.

Examples A company is making children’s SPF factor 50 washable sun cream. It is i mportant that the product meets all safety requirements so the company has set a CCP that it has to pass in i n order to meet the  product standard for Regulation (EC) No 1223/2009. It has one product per batch tested to this standard  by an external laboratory from a production of 20,000 bottles. The test is important but it is not a CCP. It is not a test that gives an indication of where a critical  production issue has to be controlled. controlled. A more realistic realistic CCP might be an online check to ensure that the total viable count of microorganisms is below the required specification and/or that the laboratory analysis of the sunscreen pH is as the specification. This can be checked, recorded and action taken if it is outside the allowed tolerance.

A company is monitoring the pH of a skin cream as a CCP. Records show that the pH was outside of the specification on several occasions but no actions were documented and it did not appear that any action had been taken. This would result in a major or even critical non-conformity since control at this point has been designated as critical to the process, but no action has been taken.

Claus e 6.1.1.9 Corrective action shall be taken in the event of deviation of the process from specification. This T his shall  be recorded.

Claus e 6.1.1.10 6.1.1.10 The hazard and risk analysis shall be reviewed whenever new product types are manufactured or significant changes are made to production methods.

Interpretation Once the HARA has been developed it must be reviewed if anything in the process changes. This c ould include buying raw materials from a different source or developing a new product or processing method. The HARA must be reviewed to establish that no new risks have been introduced. Failures of the product or similar products in service might also tri gger this review as they may indicate some hitherto underlying issue that has yet to be discovered. Other factors may include changes in legislation; some legislation, such as REACH, has been updated on a regular basis. As a result, a chemical in use now may not be acceptable in the future. For example, on 6 April 2016 the results of 48 substances evaluated under the Community Rolling Action Plan (CoRAP) were released by the European Chemicals Agency (ECHA). Since 1 September 2016 companies must apply for the approval of active substances in biocidal products that used to be outside the scope under the previous directive but now fall within the scope of the Biocidal Products Regulation. This regulation concerns two groups of substances:

 

active substances in food-contact materials for surface action; for example, antimicrobial substances used on plastic chopping boards to give them an antimicrobial surface (product type t ype 4, disinfection of material which may have contact with food)   in situ-generated active substances with precursors that were not in the scope of the directive  because they were not placed placed on the market, or because no claim w was as made that these precursors could be used for a biocidal purpose. For example, ozone generated from oxygen from the air (product type 5, disinfection of drinking water), which may be used in drinks dispensers.

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Clause 6.1.1.1 6.1.1.11: 1: hi gher The hazard and risk analysis shall also be formally reviewed at least annually and this review shall be documented.

6.1.2

Line clearance and in-process checks

Clause 6.1.2.1: foundation Before start that of any following changes product, made tothe ensure themanufacturing production lineoperation has beenand cleared and made readyoffor use. checks shall be All work instructions, raw materials, components and packaging with the necessary equipment shall be available for use.

Clause 6.1.2.1 6.1.2.1:: h igh er Before the start of any manufacturing operation, documented checks shall be carried out to ensure that the production line and the relevant areas around it have been cleared and, where necessary, cleaned, to avoid mixing with materials from the previous operations. All documentation, raw materials, components and packaging with the necessary equipment shall be available for use. It shall be possible to identify the production line with its name or identifying code as determined by the risk assessment.

Interpretation It is vital that all previous production materials are cleared away, including labels and packaging as well as components and chemicals. This is to avoid inadvertent mixing. Additionally, any instructions on manufacture or assembly should also be removed so that there is no possibility possibilit y of confusing tthem hem in any way.

6.2

Equipment and equipment maintenance

Statement State ment of int ent Equipment shall be suitable for the intended purpose and shall be used in such s uch a way as to minimise the risk of contamination of product.

Interpretation Equipment to manufacture product should be specified prior to commissioning. The T he equipment must be fit for purpose and even if it has been altered so as to manufacture a product it must perform in a way that doesn’t compromise product safety quality or legality. For example, if the product is a low pH cleaner then the plant including pipework mixing vessels and filling heads should be constructed of non-reactive nonreactive materials that won’t leach chemicals into the product and or won’t fail due to becoming  brittle for example.

Clause 6.2.1 All equipment shall be fit for purpose and constructed of appropriate materials. The design and placement of equipment shall ensure it can be effectively cleaned and maintained.

Interpretation Equipment to manufacture product should be specified prior to commissioning. The equipment must b e fit for purpose; even if it has been altered to manufacture a product it must perform in a way that does not compromise product safety, quality or legality. For example, if the product is an injection-moulded  plastic the plant, including pipework, pipework, mixing vessels and filling heads, should be constructed of nonreactive materials that will not leach chemicals into the product and will not fail because of erosion.

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Clause 6.2.2 In the case of equipment failure, procedures shall be in place to establish the sa fety and legal status of the product prior to release.

Interpretation Steps must be taken to ensure the product is still safe, legal and of the right quality in the event of plant or equipment failure. This is especially important in the case of in-line testing equipment, coding equipment or parameter monitoring/controlling equipment for a CCP.

Clause 6.2.3: foundation An implemented maintenance programme covering all items of equipment and plant which are critical to product safety, legality and quality shall be in place.

Clause 6.2.3: higher A documented planned preventive maintenance programme based on risk assessment and covering all items of equipment and plant which are critical to product safety, legality and quality shall be in place. p lace.

Interpretation Planned preventive maintenance (PPM) or planned maintenance (PM) is a form of scheduled maintenance to any item of equipment. This can be carried out by on-site on-s ite engineers or by a subcontractor on a scheduled service visit, to ensure that an item of equipment equipme nt is operating correctly and therefore avoiding any unscheduled breakdowns and downtime. Such maintenance must be carried out according to the manufacturer’s recommendations or legislation.  legislation.  

Example In the UK, a fork lift truck is legislated l egislated for under the Lifting Operations and Lifting Equip Equipment ment Regulations 1998 (LOLER), which requires the truck to be serviced (dependent upon use –  use  –  approximately twice per year) by a competent co mpetent service engineer. Other mechanical equipment such as a  power press is legislated for under the Provision and Use of Work Equipment Regulations Regulations 1998 (PUWER) (SI 1998/2306) which implement the provisions of the Use of Work Wor k Equipment Directive (89/655/EEC) and Directive 95/63/EC on the Amended Use of Work Equipment. Once again, the frequency of servicing is determined and whilst it is not concerned with productivity, some safety maintenance activities will also have production benefits. The auditor will review the equipment during the site tour and may ask to see more details of the specifications or maintenance schedules. An auditor might also examine production control records to establish whether the equipment is capable of consistently producing products which meet specification.

Clause 6.2.4 Materials (e.g. chemical lubricating oils and paints) used for equipment and plant maintenance shall be assessed to establish whether they pose a risk by b y direct or indirect contact with raw materials, intermediates, components, packaging and finished products. If necessary, they shall be suitably identified for the intended use and controlled.

Interpretation In the UK, the Control of Substances Hazardous to Health Regulations 2002 (COSHH) requires employers to either prevent or reduce their workers’ workers’ exposure to substances that are hazardous to their health. Safety data sheets (SDSs) provide information on all chemical products to help users of those chemicals make a risk assessment. They describe the hazards the chemical presents, and give information on handling, storage and emergency measures in case of accident. In the US, the Occupational Safety and Health Act of 1970 (OSH Act) (29 USC §651 et seq.; 29 CFR Parts 1900 to 2400) requires manufacturers and importers of hazardous materials to conduct hazard evaluations of the products they manufacture or import. If a product pr oduct is found to be hazardous under the terms of the standard, the manufacturer or importer must so indicate on containers of the t he material, and

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the first shipment of the material to a new customer must include a material safety data sheet (MSDS). ( MSDS). Employers must use these MSDSs to train their employees to recognise and avoid the hazards  presented by the materials. In Australia, the Work Health and Safety Regulations (WHS) require the manufacturer or importer of a hazardous chemical to prepare an SDS for the chemical. Additionally, a supplier must provide the manufacturer ’’s  s or supplier’s current SDS for the hazardous chemical on first supply to a workplace and upon request. If a chemical was to pose a risk to a worker, then that chemical would possibly pose a risk to the endconsumer.

Clause 6.2.5 Repairs or servicing of equipment shall be completed by competent maintenance personnel.

Clause 6.2.6 When possible, equipment shall be positioned so as to give access beneath, inside and around it for ease of cleaning and servicing.

6.3

Product contamination control

Statement State ment of int ent Appropriate facilities and procedures shall be in place to control the risk of foreign body, chemical or  biological contamination.

Interpretation The site must identify the level of control that is required. There are various kinds of foreign foreign-body -body detection but this clause most commonly applies to metal detectors. The BRC best-practice guideline, Foreign Body Detection, gives guidance for those seeking further information.

6.3.1

Identification and prevention of risk of product contamination

Claus e 6.3.1.1 The site shall ensure that all necessary steps are taken to identify and prevent the risks of foreign body, chemical and biological contamination as identified by risk assessment. This shall include any contamination potentially introduced by raw materials, components or packaging.

6.3.2

Chemical and biological control

Claus e 6.3.2.1 Processes shall be in place to manage the use, storage and handling of non-production chemicals and  biological materials to prevent contamination. contamination. These shall include as a minimum:

       

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a list of approved chemicals for purchase availability of material safety data sheets the labelling and/or identification of containers of chemicals and biological materials at all times ti mes a designated storage area with access restricted to authorised personnel.

6.3.3

Metal control

Claus e 6.3.3.1 Tools and other sharp metal implements including knives, cutting blades, needles, perforation blades and wires used in production shall be controlled where there is a risk of o f product contamination. Methods such as, but not limited to, the following may be used:

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tools permanently attached to equipment to prevent loss items controlled by an issue listing and registration procedure recovery of all parts of broken needles before the issue of a replacement r eplacement needle.

Snap-off-blade knives shall be prohibited.

Claus e 6.3.3.2 Staples, paper clips and drawing pins shall not be used in open product prod uct areas. Where staples or other items are present as packaging materials or closures, appropriate appropr iate precautions shall be taken to minimise the risk of product contamination.

Interpretation There should be clear controls in the case where staples are used to close boxes, or metal closures are used for banding. This is important both bo th with regard to the loose staples or closures and to the quality of the form so that there are no sharp edges or other hazards.

6.3.4

Glass, brittle plastic, ceramics, wood and similar materials control

Claus e 6.3.4.1 Glass or other brittle materials shall be excluded or protected against breakage in areas where there is a risk of product contamination.

Interpretation Breakages need to be controlled. There should be a process for ensuring all of the sharp material is accounted for in the event of a breakage. In some cases this may involve reconstructing the broken item to see if anything is missing. As well as cleaning up the broken items, some so me companies will use dedicated or disposable equipment to prevent the spread of small particles.

Claus e 6.3.4.2 Where there is a potential risk to product all glass, ceramic, wood and brittle -plastic items in  production areas (except where the item is part of the product) shall be included in the risk assessment and listed in a register. Documented procedures for handling these materials shall include:

     

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regular checks of the condition of these materials carried out at specified intervals and recorded recording of all breakages in an incident report segregation of contaminated product

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recording details of cleaning or replacement to minimise potential for product contamination.

Interpretation It is important to assess the risk ris k to the product from any non-production non-pr oduction glass, ceramics or indeed any material that could become sharp when broken. The risk is obvious in i n the case of a glass window in a  production hall, but may be considerably considerably less obvious for a changing-room mirror.  

Examples During the audit the auditor notices that the mirror in the ladies’ changing room is c racked. Upon investigation the site quality manager tells the auditor that they had not considered the changing rooms to be an area where the glass needs to be monitored and it is not mentioned in the register. The auditor reviews the risk assessment and confirms that the site s ite thought that the mirrors and windows in the changing areas were far enough away from the production hall to be of little or no risk to the product. The auditor would accept this argument if the consideration was reasonable. However, if there was a  possibility of glass fragments fragments being transferred into the pro production duction areas on the staff ’  ’ s workwear, the auditor would raise a non-conformity.

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During the audit the auditor notices that the reed diffuser filling line and the candle line both ha ve glass receptacles. The process is defined and in the event of glass breakage br eakage the line operatives are required to use a disposable broom and dustpan system. The equipment is colour-coded colour -coded yellow and is thrown away following the clear-up. This would be acceptable.

6.3.5

Foreign body detection and removal equipment

Statement State ment of int ent The risk assessment shall identify the potential use of equipment to detect or remove foreign body contamination.

6.3.5.1 6.3 .5.1 Filters and sieves Claus e 6.3.5.1.1 6.3.5.1.1 Filters and sieves used for foreign body control shall be of a specified mesh size or gauge and designed to provide the maximum protection that is practical for the product. Material retained or removed by the system shall be examined and recorded to identify risks.

Clause 6.3.5.1.2: foundation Filters and sieves shall be regularly inspected and tested for damage. Defective sieves and filters shall be segregated and appropriate action taken to replace them. Records shall be maintained.

Clause 6.3.5.1. 6.3.5.1.2: 2: h igh er Filters and sieves shall be regularly inspected and tested for damage at a documented frequency determined by the risk assessment. Defective sieves and filters shall be segregated and appropriate action taken to replace them. Records shall be maintained.

6.3.5.2 6.3 .5.2 Metal detecto rs and X-ray equip ment Claus e 6.3.5.2.1 6.3.5.2.1 Where a metal or other foreign body detector is required based on risk assessment, assess ment, the company shall establish documented procedures specifying the methods and frequency of testing, critical limits for detection, and recording of test results.

Claus e 6.3.5.2.2 6.3.5.2.2 The metal detector or X-ray equipment shall incorporate one of the following:

   

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an automatic rejection device a belt stop system with an alarm where the product cannot be automatically rejected (e.g. for very large packs) in-line detectors which identify the location of the contaminant to allow effective segregation of the affected product.

Claus e 6.3.5.2.3 6.3.5.2.3 Systems shall be in place to segregate product rejected by the metal detector to prevent accidental reintroduction and allow investigation of the source of the metal contaminant.

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Clause 6.3.5.2.4: foundation The company shall examine product rejected by the metal detector and retain any metal contaminant. The source of the contamination shall be investigated and appropriate corrective action taken to minimise the risk of further contamination. Records shall be maintained.

Clause 6.3.5.2. 6.3.5.2.4: 4: h igh er There shall be a documented procedure to examine product rejected by the metal detector and to retain any metal contaminant. The source of the contamination shall be investigated and appropriate corrective action taken to minimise the risk of further contamination. Records shall be maintained.

6.3.5.3 Magnets Claus e 6.3.5.3.1 6.3.5.3.1 The type, location and strength of magnets shall be recorded in a register. Documented procedures shall be in place for inspection, cleaning, strength testing and integrity checks. Records of all checks shall be maintained.

Claus e 6.3.5.3.2 6.3.5.3.2 Optical sorting equipment shall be checked on the the basis of the manufacturer’s instructions or recommendations. Records of all checks shall be maintained.

6.4

Calibration and control of measuring and monitoring devices

Statement State ment of int ent Measuring equipment used to monitor product safety, quality and legality shall s hall be calibrated and of suitable accuracy for its intended purpose.

Interpretation This section requires equipment to be properly identified, listed and calibrated at an appropriate frequency by suitably qualified staff. It is easy to believe test t est results, but if the equipment being used to take the measurements is incorrect this can lead to a false sense of security and unsafe products being  produced. The clauses require that equipment is not adjusted by untrained operators and that each piece is suitably labelled with its calibration status. Auditors will wish to see calibration certificates. The calibration range and discrimination are very important. For example, if a thermometer has been calibrated as accurate between 10°C and 100°C, it cannot be reliably used for measurements of 150°C. If a balance has been confirmed as accurate for weighing between 10 g and 100 g at an accuracy of 0.1 g, it cannot be used to record weights to the nearest 0.001 g.

Example A factory has a number of balances with which it check-weighs products to ensure that they are to specification. It also operates within temperature- and humidity-controlled environments, which are monitored. None of the equipment has been calibrated over the past year. The auditor is told t hat the

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calibration laboratory has increased its prices and the site cannot afford to maintain calibration. A representative of the site says they are sure that the equipment will still be acceptable, because it was in calibration when it was last checked. This would not only raise a non-conformity about the calibrations but would also highlight a lack of  provision of resources resources for a key task.

Clause 6.4.1 The site shall have a list of equipment used to make measurements relevant to product safety, legality and quality.

Interpretation Although this sounds relatively simple, in some industries where the process is steamy or oily the labels may simply not stick. A good deal of research may therefore be needed to find a system that works. In many cases where gauge use is high the system s ystem used is colour-coded to show the calibration status of the gauge.

Clause 6.4.2 The equipment used to accept or reject a product shall be calibrated to a specified accuracy and  precision at a defined frequency (or before use).

Examples A usesnotes a pHthat meter calibrates every day. at The results ometer f the calibration arepH reviewed thelaboratory auditor, who theand readings showittwo points which theof is calibrated: 4.0 andby  pH 7.0. The recorded calibration readings show a record of pH 4.0 and pH 7.0 for every calibration. The auditor asks to see the calibration being performed and watches the technician follow the  procedure, press the calibration button and record the reading after calibration. calibration. ’, without The auditor raises a non-conformity as there is no record of the ‘ as-found as-found measurement ’, which it is not possible p ossible to determine whether once a day is the correct frequency.

The auditor asks to see the micrometer used by a sheet metal worker. On examination the auditor holds the gauge up to the light and discovers that the spindle of the gauge is not parallel to the frame. As a result it does not sit squarely on the anvil. The T he worker admits to having dropped it the previous week. The auditor raises a non-conformity as the gauge is no longer in calibration and the incident had not been reported.

Clause 6.4.3: 6.4.3: higher The calibration of identified equipment shall be traceable to a recognised national standard. Where such a standard does not exist, the basis by which calibration is declared shall be verified. Interpretation A calibration check may be carried out in-house, as long as it is performed to a documented method by competent staff, using appropriate reference standards/equipment. The T he reference standards/equipment will need to be calibrated by a laboratory that can demonstrate de monstrate competence, measurement capability and traceability. For example, in the UK this would be a UKAS-accredited calibration laboratory (ISO 17025); in the US, the National Institute of Standards and Technology T echnology (NIST); in India, the  National Accreditation Board Board for Testing and Calibration Laboratories (NABL). As a guide, any instrument or reference standard should have an accuracy 10 times greater than that of the device being calibrated.

Example A device having a ±0.5% tolerance might be b e calibrated using a standard having an uncertainty of ±0.05%. There may, however, be exceptions to this rule where a factor of 2 or 5 may be acceptable.

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This science is known as metrology and is used for the determination of accurate gauges measuring optical and ionizing radiation and properties that are:

         

dimensional electromagnetic environmental mechanical thermodynamic

 

time- and frequency-dependent.

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Some gauges are not traceable to a national standard (e.g. pH or the classification of a steel type according to ISO/TS 4949:2003) so standards have been set up by which comparisons can be made.

Clause 6.4.4: 6.4.4: higher Records of the results of calibration and verification shall be maintained for a suitable period, taking account of the life of the products being produced.

Clause 6.4.5: foundation Adjustment of identified equipment by unauthorised staff shall be prevented and the equipment shall be marked to show its calibration status and period of validity. A process shall be in place for actions to be taken if equipment is found not to be operating within specified tolerances and/or limits.

Clause 6.4.5: higher Adjustment of identified equipment by unauthorised staff shall be prevented and the equipment shall be marked to show its calibration status and period of validity. Procedures shall be in place for actions to be taken if equipment is found not to be operating within specified tolerances and/or limits.

Interpretation Gauges such as thermometers can be reset to zero at any point so this requirement needs to be controlled by access and authority. If a gauge is found to be out of calibration for whatever reason it is usual to refer to the last ti time me the equipment was in calibration, then recheck the results from that point until now.

6.5

Final product packing and control

Statement State ment of int ent The company shall ensure that products are packed in accordance with customer-specified requirements and any relevant safety criteria, quality and legal requirements.

Interpretation Even if a product has been made successfully, it can be unsafe or not of o f the right quality if it is not  packaged correctly or put in the wrong wrong box. The site needs to have a procedure in place to ensure that this cannot happen. In the case of quantities, it may well be b e a legal requirement that suitable checks are in place.

Examples A company making hair dye does not have an appropriate final pack procedure. It packs the wrong colour dye into the wrong boxes. Many consumer complaints are received.

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The same company corrects the error but packs the wrong language edition of the instruction sheet into the boxes. Customers cannot understand the instructions and are at risk of damaging their hair or even injuring themselves through incorrect application.  Both these actions would result result in a non-conformity, and highlight the importance importance of proper control at the packing stages.

Clause 6.5.1: foundation Before the start of the packaging operation and following changes of product, checks shall be carried out to ensure that the packing line has been cleared and made ready for packing. All work instructions and packaging materials shall be available for use.

Clause 6.5.1: higher Before the start of the packaging operation, documented checks shall be carried out to ensure that t he  packing line and the relevant relevant areas around it have been clea cleared, red, and where necessary cleaned, to avoid mixing with materials from the previous operations. All documentation and packaging materials shall be available for use. The packing line shall be identifiable by its name or identifying code as determined by the risk ris k assessment.

Interpretation  Applies at both foundation and higher levels Almost a third of all product recalls are as a result of o f ‘the wrong item in the box’. One way this can occur is when the line changes over and the previous packaging (including insertions) is still stil l available. Some companies have adopted a just-in-time approach where the product and packaging are brought to the line only when they are needed.

Clause 6.5.2: foundation The company shall ensure that product packing is effectively managed to ensure that it meets customercustomer specified packing requirements for the product. This shall include methods of ensuring that the correct product(s) and components co mponents are correctly  packaged and placed in the correct outer packaging.

Clause 6.5.2: higher The company shall have a validated, documented procedure for the packing of products taking  particular account of customer requirements. requirements. This shall include methods of ensuring that the correct product(s) and components co mponents are correctly  packaged and placed in the correct outer packaging.

Clause 6.5.3 The quantity of product should match the quantity markings, which should be accurate, verified and in accordance with the legal requirements in the country of sale.

6.6

Stock control and product release

Statement State ment of int ent The company shall ensure that stock and finished product are not released unless all agreed procedures have been followed and the release is suitably controlled.

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Clause 6.6.1 Controls shall be in place to ensure correct stock rotation and that materials and products are a re used in the correct order and within the allocated shelf or usage life as applicable.

Interpretation This section of the Standard addresses stock rotation. This is i s obviously important if products have a limited shelf life, but it is generally good practice to ensure that stock is shipped in the order of  production. Even products that do or notinstructions, deteriorate with w ith become age should because information such as addresses, phone numbers can out be of considered date. Companies should b e able to be demonstrate how they control the organisation of the dispatch process.

Clause 6.6.2 The company shall ensure that product brought in from off-site off -site subcontractors shall be included in the  product release procedure.

Interpretation Sites often have problems with subcontracted work as they do not control it as rigorously as work  produced on site. This clause ensures that any subcontracted subcontracted work is subject to the same level of control as work produced on site. There shall be a procedure for the selection and instruction of subcontractors and for the acceptance of  products received from subcontractors. This may include documentation checks, inspection, testing or a combination of may these.beThe products beKPIs subject to an authorised release system. Subcontractors subject to theshall same as the site o f major positive of manufacture. This clause includes work produced by home workers and the material they use, which must be controlled in the same way as work produced on site, because the same safety or quality problems may occur. Home workers should have documented work instructions and any equipment they use must be subjected to maintenance procedures and calibration as necessary. Home workers must be made aware of any issues concerning product safety that are pertinent to their work –  work  –  for  for example, avoiding foreign-body contamination and control of sewing needles.

Clause Cla use 6.6.3: 6.6.3: fo undation Only products conforming to specification and agreed quality requirements are to be released for dispatch. If no such control is conducted, the company shall have a full justification for its absence documented in the customer agreement, which shall be reviewed at least annually.

Clause 6.6.3: higher A documented procedure shall be in place to ensure that only products conforming to specification are released for dispatch. Procedures may include, but are not limited to:

   positive final release by authorised staff   online test methods   automatic rejection process (which shall be validated and monitored).

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If a risk assessment determines that no such control is required, the company shall have a full  justification for its absence, which is documented documented in the customer agreement and shall be reviewed reviewed at least annually.

Interpretation Once products have been produced, the final stage is to control the dispatch so that no substandard s ubstandard  products are released. The Standard requires a robust system to be in place. It does not specify the  procedure to be used but suggests some common methods. methods.

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The most usual method is by ‘positive release’, where products have to be approved for release by a suitable person authorised to do so. This means that products do not just get sent out and only stopped when or if there is a problem, but that every batch is checked and positively agreed to be satisfactory  before it can be shipped. For example, example, a mascara may be held until the microbiology results are available.

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7

Personnel

7.1

Training and competency

Statement State ment of int ent  FUNDAMENTAL 

The company shall ensure that personnel performing work that affects product safety, legality and quality are demonstrably competent to carry out their activity, through training, work experience or qualification.

Interpretation In order to produce anything successfully, it is important that employees are competent, well trained and understand their duties. Auditors will expect sites to be able a ble to show that staff meet these requirements, and they will probably interview and observe staff to judge the extent to which this requirement has been met. Auditors are likely to focus mainly on production, quality and technical staff but any others who could influence the products should also be considered, such as dispatchers, cleaners and administrators taking orders. It is a requirement that those carrying out the risk assessment (to ensure products are safe and legal) have some formal training. The training types and methods are not specified because different levels and types of training will be appropriate in different industries. However, it is likely that the auditor will challenge staff’s understanding of risk methods. If the auditor a uditor is in any d doubt oubt as to the staff’s understanding of a process or is unconvinced by the results of risk assessments, they will evaluate the training.  Note that the requirements of this section apply to general duties as well as to specific job training. Basic understanding understanding of a site’s procedures is as important as specialist knowledge. Misunderstanding the site procedures (relating, for example, to storing products in the wrong places, not using usi ng the correct tools, or not understanding the site requirements for hand-washing) hand- washing) may have a deleterious effect on safety.

Example An auditor is visiting a factory producing first-aid first -aid kits and asks an operative what their duties are with regard to packing the cartons into outer boxes. The operative does not appear to understand and is not  packing the same way as operatives operatives on other lines. The auditor seeks clarification from the supervisor and is told that the operative, whose first language is not used on the site, is new and has been sent by an agency as temporary staff to help with a backlog of work. The auditor raises a non-conformity. The site must have a way of ensuring that all staff are competent and clearly understand their job. In this case, some hands-on training, followed by sign-off after the operative had demonstrated competence, would be appropriate.

Clause 7.1.1: foundation The company shall ensure that all employees are able to demonstrate competence with regard to their activity.

Clause 7.1.1: higher The company shall ensure that all employees are able to demonstrate competence with regard to their activity. The company shall:

   

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identify the need for training document training procedures and records to demonstrate that training is effective and regularly reviewed

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ensure that training includes both general information on the company and specific job training retain all training records.

Interpretation The auditor will judge the competency of staff through records, observation and interview. They will look for job descriptions and ensure that they correspond with staff’s own views of their roles. They will also look for evidence that any necessary training has been carried out and its success evaluated. The need for training and records does not mean that experienced personnel without formal qualifications are not acceptable. acceptab le. Their experience can be evaluated and documented and ‘grandparent rights’ may be an acceptable assessment in some cases.  cases.  

Clause 7.1.2 Training records shall be stored in such a way as to ensure privacy of personnel is protected and legal compliance with data protection laws in the country of operation are respected, while also allowing auditors access to necessary information. Training shall be traceable to an individual employee.

Interpretation A training record should be traceable to an individual, and should cover all their relevant r elevant responsibilities, taking account of any privacy laws that apply. The site should give due attention to refresher training. The auditor will wish to review training procedures and records on part of their site tour. For example, they will observe how staff have been trained to use a new piece of equipment, or how ho w they are made aware of the requirements of a new customer. The auditor does not want to see payroll pa yroll information, tax details or health details; this type of information informa tion can be divulged only with the employee’s express  permission.

Examples A factory operative is asked by the auditor about methods of adjusting a computer-controlled computer -controlled cutting machine. The operative does not appear to know. When asked, the supervisor produces prod uces evidence that the operative was sent on an external course to learn about the machine. On further questioning it appears that the operative did not understand the course, they did not go back for the second day of instruction, and no evaluation or questionnaire about the course had been completed. The operator could not demonstrate competence or adequate training and so a non non-conformity -conformity would be raised.

The test laboratory in a factory has just bought a new piece of equipment to test its products for t oxic metals. The laboratory supervisor used a similar machine several years ago but other staff are not familiar with it. An in-house training session has been arranged with the supplier, and all staff will complete the training before commissioning the new equipment. The laboratory has also signed up to a correlation trial to ensure that its results are reliable. This is a satisfactory way of addressing an issue when no-one on o n site has the required competence to carry out training.

A qualified supervisor has carried out some basic hygiene training for shift workers. Unfortunately, although the training has been minuted and dated, it is not possible to check which operators were  present at the time. The auditor would raise a non-conformity, although the problem could easily have been solved if each operative had signed an attendance sheet, which was then filed with the record of the training.

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7.2

Protective clothing

Statement State ment of int ent The company's standards shall be documented and adopted by all personnel, including contractors and visitors to the production facility.

Interpretation Any clothing provided as protection shall not, itself, present a contamination risk to the products. pro ducts. In many industries no particular requirements are necessary, but even so, appropriate appr opriate controls should be in  place, such as using only approved laundry laundry companies. If, for example, protective clothing clothing is required, the laundering methods (including frequency and suitability) shall be documented and assessed. When staff are responsible for their own laundry, the site should s hould have clear procedures on the process that should be used, to ensure that product safety and quality are maintained.

Clause 7.2.1 The company shall use risk assessment to determine the need for protective clothing. Where a need for protective clothing has been identified by the risk assessment, this shall not pose a contamination risk to the product.

Clause 7.2.2: 7.2.2: higher Based on the assessment of risk to the product integrity, suitable suit able footwear shall be worn within the factory environment.

Clause 7.2.3: 7.2.3: higher Protective clothing, where provided, shall be effectively laundered at an appropriate frequency. Disposable protective clothing, if used, shall be subject to adequate control to avoid product contamination.

7.3

Hygiene practices

Statement State ment of int ent Standards of hygiene shall be applied with due regard to the risk of product contamination.

Interpretation This clause encompasses good manufacturing practices and requirements for HARA. It is very important in high-risk product areas such as nursery accessories, accesso ries, cosmetics and medical devices. It is necessary not only to meet the requirements but also to monitor whether they are being implemented and take action on any lapses. The auditor will observe whether this requirement requir ement is being complied with throughout the course of the audit.

Clause 7.3.1: foundation Where the risk has been identified, the company shall have a policy to control the wearing of jewellery so that it poses no risk of product pro duct contamination.

Clause 7.3.1: higher The company shall have a policy to control the wearing of jewellery so that it poses no risk of product contamination.

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Clause 7.3.2 All cuts and grazes on exposed skin shall be covered by a contrasting coloured plaster that is issued and monitored by the site, to avoid contamination of product.

Clause 7.3.3: 7.3.3: higher Where metal foreign body detection is in place, detectable plasters shall be used and shall be regularly tested through the detector.

Clause 7.3.4 Hand-cleaning shall be performed at a suitable frequency to maintain hygienic conditions.

Clause 7.3.5 Eating, drinking or smoking shall only be permitted within designated areas and where there is no risk r isk of contamination of products.

Clause 7.3.6: 7.3.6: higher The company shall use risk assessment to determine d etermine the need for all head and facial hair to be covered and fully contained to prevent product contamination.

Interpretation It is estimated that 50 – 150 150 head hairs per day fall out and if you run your fingers through your hair, five or six can be dislodged. Information on beard shedding is not as readily available. Comment groups suggest that beards may shed hair at a somewhat lesser rate but it would appear that the longer the beard, the more similar the rate is to head hair. If it is determined that hair covering is rrequired, equired, then the wearing of the hairnet/beard snood must cover all hair and not allow any hair to be exposed.

Clause 7.3.7: 7.3.7: higher Where there is a risk to product safety and quality, fingernails shall be kept short, s hort, clean and unvarnished. False fingernails shall not be permitted.

Clause 7.3.8: foundation Where there is a risk to product safety and legality, the site should have a procedure for the notification  by personnel, including temporary personnel, personnel, visitors and contractors, of any relevant infectious diseases or conditions which they may have been in contact with or be suffering from.

Clause 7.3.8: higher The site shall have a documented procedure for the notification by personnel, including temporary  personnel, visitors and contractors, of any relevant relevant infections, diseases or conditions which they may have been in contact with or be suffering from.

Interpretation Certain infectious diseases can be passed on; therefore high-risk products pr oducts are commonly tested for the following bacteria:

  Staphylococcus aureus  –  –  found  found in the nose    Escherichia coli  –  found in the lower intestine   Pseudomonas aeruginosa  –  –  found  found on the skin   Candida albicans  –  –  found  found in the mouth and on nails    Aspergillus niger   –  –  found  found on fruits and vegetables.

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The notification can be in the form of a voluntary declaration; however, ho wever, there is legal protection for the non-disclosure of sensitive information, such as:

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  religious beliefs   health   ethnic background   age   sexual health   criminal records    political opinions.

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In Europe this is Directive 95/46/EC on the protection of individuals with regard to the processing of  personal data and on the free movement movement of such data. In the US it is the Privacy Act of 1974.