Checklist Audit ISO 22000
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Checklist Audit ISO 22000...
Description
CHECKLIST AUDIT ISO 22000
Conformance Clause
4
Requirement
FOOD SAFETY MANAGEMENT SYSTEM
4.1.
GENERAL REQUIREMENTS
4.1
Scope of the FSMS defined
4.1
Scope of the FSMS specifying: •
Product categories
•
Processes
•
Production sites
4.1 4.1
Any outs outso ourc urced proc proces ess ses relat elated ed to food safety are controlled, identified and documented within the FSMS
4.2.
DOCUMENTATION REQUIREMENTS
4.2. 4.2.2. 2.
Cont Contro roll of of doc docum umen ents ts A documented procedure procedure for control of documents required by the FSMS, FSMS, includes:
a)
Appro proval of doc documents for adequacy acy prior to issue
b)
Review, up update an and re re-approve
c)
Changes an and cur currrent re revision status identified
d)
Releva evant versions of documents available at points of use
e)
Legible and re readily id identifiable
f)
Identifi ification an and co control of of ex external documents
g)
Prevent un unint intended ded us use of of ob obsolet lete documents, and to suitably identify them if they are retained for any purpose
4.2.3
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Control of of re records Procedure for efficient & accurate accurate record keeping to provide evidence of conformity to requirements and of the effective operation of the FSMS Records legible, readily identifiable and retrievable Control of the correction, identification, storage, protection, retrieval, retention time and disposition of records
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Observations & objective evidence
CHECKLIST AUDIT ISO 22000
Conformance Clause
5
Requirement MANAGEMENT RESPONSIBILITY
5.1.
MANAGEMENT COMMITMENT
5.1
Evidence of of to top ma management commitment to the FSMS FSMS and its continual improvement: improvement: objectives (5.3) – commun communica icatin ting g (5.6.2 (5.6.2.) .) – policy policy (5.2) (5.2) – managemen managementt review review (5.8.) (5.8.) – resource resources s (6)
5.2.
FOOD SAFETY POLICY
a)
Appr Approp opri riat ate e to to the the role role in the the foo food d cha chain in
b)
Comm Commit its s to compl omply y with ith sta statu tuto tory ry,, regulatory and customer FS requirements
c)
Comm Commun unic icat ated ed and and und under erst stoo ood d wit withi hin n the organization (5.6.)
d)
Revi Review ewed ed for for con conti tinu nued ed sui suita tabi bili lity ty (5. (5.8) 8)
e)
Supp Suppor orte ted d by by meas measur urab able le obje object ctiv ives es
5.3.
FOOD SAFETY MANAGEMENT SYSTEM PLANNING
a)
To me meet th the ob objectives
b)
To main mainta tain in the the FSM FSM inte integr grit ity y when hen changes are implemented
5.4.
RESPONSIBILITY AND AUTHORITY R&A are defined and communicated within the organization Identified person(s) to receive reports problems with the FMS Designated personnel to initiate and record actions
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CHECKLIST AUDIT ISO 22000
Conformance Clause 5.6.
5.6. 5.6.1. 1.
Requirement COMMUNICATION Exte Extern rnal al commu communi nica cati tion on Implemented effective arrangements for communica communicating ting with with :
a) b)
Supplier liers s an and co contractors Custo ustom mers ers / Con Consu sum mers ers: •
c) d)
product information (see 7.3.3.2)
•
enquiries
•
contracts / order handling
•
customer feedback / complaints
Food authorities Other ther orga organi niza zati tion ons s that that coul could d be affected Provided information on FS aspects of products that may be relevant to other organizations, especially to hazards that need to be controlled. Records maintained. Legal and customer FS requirements recorded Designated Designated personnel personnel to manage the external communication
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Observations & objective evidence
CHECKLIST AUDIT ISO 22000
Conformance Clause
5.6.2.
Requirement Intern ernal com communication ion The Top management has communicated to the organization the importance of meeting this standard, legal and customer FS requirements Implemented effective arrangements for communicating with relevant personnel in FS: FST is informed of changes, especially:
a)
Products or new products
b)
Raw material ials, in ingre gredients nts and services
c)
Prod Produc ucti tion on systems ems and and equi equip pment ent
d)
Prod Produc ucti tion on prem premiises, ses, loca locattion ion of equipment, surrounding environment
e)
Cleaning and and sanitation pr programs
f)
Packaging ing, st storage an and dis disttribution systems
g)
Pers Person onne nell qual qualif ific icat atio ion n leve levell / allo alloca cati tion on of responsibilities and authorizations
h)
Regulatory requirements
i)
Knowled ledge regarding ing food safety hazards and control measures
j)
Customer, sector and and other requirements
k)
Rele Relev vant ant enqu nquirie iries s fro from exte exterrnal nal interested parties
l)
Complaints in indicating ha hazards associated with the product
m)
Any Any cond condit itio ion n which hich hav have an an impa impact ct on food safety
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CHECKLIST AUDIT ISO 22000
Conformance Clause 5.8. 5.8.1.
Requirement MANAGEMENT REVIEW At planned intervals Records maintained
5.8.2.
Inputs:
a)
Follo llow-up actions fr from pr previous reviews
b)
Veri Verifi fic catio ation n ac activ tivitie ities s (s (see 8. 8.3.3) 3.3)
c)
Changes related FS (see 5.6.2)
d)
Emer Emerge genc ncy y sit situa uati tion ons, s, acc accide idents (s (see 5.7) and recalls (see 7.10.4)
e)
Syst System em up-d up-dat atin ing g acti activi viti ties es (see see 8.5. 8.5.2) 2)
f)
Com Communica nicati tion on activ tivitie ities s incl inclu uding ding customer feed-back (see 5.6.1)
g)
Ext Extern ernal audits its or or in inspections
5.8.3.
Outputs:
a)
Assu Assurranc ance of of food food safet afety y (se (see 4.1. 4.1.))
b)
Impr Improv oved ed effe effect ctiv iven enes ess s of of the the FSM FSMS (see 8.5.)
c)
Resource ne needs (s (see 6. 6.1)
d)
Rev Revisio ision ns of the the FSP FSP and and ob objec jectiv tives (see 5.2).
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CHECKLIST AUDIT ISO 22000
Conformance Clause
6 6.2.
Requirement RESOURCE MANAGEMENT HUMAN RESOURCES
6.2.2
For pe personnel relevant in in FS FS
a)
Identify ne necessary co competencies
b)
Training
c)
Specific training for person nel responsible of monitoring, corrections, and corrective actions
d)
Evaluation of implementation and effectiveness
e)
Awareness of contribution to FS
f)
Awareness of need for effective communication
g)
Records of training and other actions
6.2. 6.2.1. 1.
Agre Agreem ement ent or contr contrac acts ts with with exte extern rnal al experts involved in FSM
6.3 6.3.
INF INFRASTRUCT UCTURE (see 7.2.3.)
6.4.
WORK E NV NVIRONMENT (see 7.2.3.)
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CHECKLIST AUDIT ISO 22000
Conformance Clause
Requirement
7
PLANNING AND REALIZATION OF SAFE PRODUCTS
7.2. 7.2.2.
PRPs PRPs shall be
a)
Appr Approp opia iate te to the the org organ aniz izat atio ion nal need needs s
b)
Appropiate to the size ize and type of operation and product
c)
Implemented ac across:
d) 7.2.3.
•
General programmes
•
Specific programmes
Approved by FST According to •
Legal requirements
•
Customer requirements
•
Recognized Recognized guidelines guidelines
•
Codex Alimentarius
•
Codes of practices
Specific documents to manage PRPs 7.5. 7.5.
Esta Establ blis ishi hin ng the the oper operat atio ion nal PRPs PRPs
Documentation for each programme: a)
Hazards controlled
b)
Control measure(s)
c)
Monitoring procedures
d)
Corrections/ corrective actions
e)
Responsibility & Authority
f)
Records of monitoring
7.2.3.
Elements of PRPs
a)
Lay-out, design and construction of buildings and facilities:
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•
Location
•
Perimeter and grounds
•
Walls
•
Floors
•
Ceilings
•
Windows
•
Doors
•
Lighting
•
Ventilation
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CHECKLIST AUDIT ISO 22000
Conformance Clause
b)
Requirement Lay/out of premises, including workspace and employee facilities: •
Process flow
•
Working space and storage
•
•
•
Segregation Low/High risk areas/process Segregation design Washing and cleaning locations
•
Changing facilities
•
Hand washing facilities
•
Toilets
•
Catering facilities
c)
Supplies of air, water, energy and other utilities
d)
Supporting se services in including wa waste and sewage disposal
e)
Equipment in including it its pr preventative maintenance, sanitary design and accessibility for maintenance and cleaning for each unit
f)
Management of of pu purchased ma materials, disposals and handling of products: •
Raw materials
•
Ingredients
•
Packaging
•
Chemicals
•
Waste
•
Sewage
•
•
g)
Storage of raw materials / packaging / in process / end products Transportation
Measures for the prevention of cross contamination
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CHECKLIST AUDIT ISO 22000
Conformance Clause
h)
Requirement Cleaning and sanitizing: •
Cleaning practices
•
Cleaning schedules
•
•
i)
Documented procedures / records
Pest control: •
•
•
•
•
•
j)
Control and verification of effectiveness
Competent pest control Documented procedures / records Physical measures: drains, hermetical hermetically ly sealed sealed doors, doors, screens, security perimeter for inspection in storage, etc,. Location of all measures Plan/diagram for electric fly killers / baits / traps Risk of product contamination with chemicals
Personnel hygiene: •
GMP´s
•
Protective clothing
•
Jewellery
•
Cuts and grazes
•
Hand cleaning
•
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Notification of relevant infectious disease or conditions
•
Medical screening
•
Training
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CHECKLIST AUDIT ISO 22000
Conformance Clause 7.3.
Requirement PRELIMINARY STEPS TO ENABLE HAZARD ANALYSIS
7.3.1.
General Relevant information needed to conduct the hazard analysis documented, collected, maintained and updated
7.3.2.
Food Safety Team (FST) (5.5.) FST Leader appointed by Top Management with responsibility:
a)
To manage the FST
b)
Traini ining & edu education of FST members
c)
To ens ensur ure e that that FSMS SMS is esta establ blis ishe hed, d, implemented, maintained and updated
d)
To re report ort to to Top Top Manage agement ab about FSMS Multi-disciplinary knowledge and experience Records demonstrate the required expertise expertise for all team members members
7.3.3.
Product characteristics
7.3.3.1.
Raw materials, ingredients and product-contact materials Specifications with:
a)
Biological, chemical and physical characteristics
b)
Ingredients including ad additives and processing processing aids
c)
Origin
d)
Method of production
e)
Delivery methods and packaging
f)
Storage conditions and shelf life
g)
Preparation and/or handling before use or processing
h)
Food safety related acceptance criteria or specifications specifications of purchased purchased materials and ingredients appropriate to their intended uses Relevant legislation/ regulations documented Specifications updated
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Observations & objective evidence
CHECKLIST AUDIT ISO 22000
Conformance Clause 7.3.3.2.
Requirement Characteristics of end products Specifications with:
a)
Name
b)
Composition
c)
Biological, chemical and physical characteristics
d)
Intended shelf life and storage conditions. Intended use (see 7.3.4.)
e)
Packaging
f)
Labelling re relating to to fo food sa safety and/or instructions for handling, preparation and usage
g)
Method(s)of di distribution Relevant legislation/ regulations documented Specifications updated
7.3.4.
Intended use Identified & documented appropriate information about : •
•
The reasonably expected handling of the product Any unintended but reasonably expected mishandling and misuse of the product
Group of consumers identified, specially vulnerable groups of population Descriptions updated 7.3.5.
Flow diagrams, process steps and control measures
7.3.5.1.
Flow diagrams For each product / process category covered by the FSMS Sufficient detail / schematic overview Including
a)
Sequence / interaction of steps
b)
Outsourced processes and subcontracted work
c)
Inputs (r (raw materials, ingredients, intermediate products)
d)
Reworking and recycling
e)
Outputs (end, intermediate, byproducts, waste) Verified by FST (records)
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CHECKLIST AUDIT ISO 22000
Conformance Clause 7.3.5.2.
Requirement Description of process steps and control measures Control measures/process parameters/ procedures related to food safety described Legal and customer requirements described Descriptions updated
7.4.
HAZARD ANALYSIS
7.4.2.
Hazard identification and determination of acceptable levels
7.4. 7.4.2. 2.1. 1.
Ident Identif ifie ied d & recor recorde ded d Specific for the type of product / process and facilities Based on :
a)
Preliminary information about product / process and control measures (7.3.)
b)
Experience
c)
External information including epidemiological and other data historical
d)
Information fr from the food ch chain
e)
Step (s) related which each hazard
7.4. 7.4.2. 2.2. 2.
Cons Consid ider erin ing g:
a)
Prior – su s ubsequent steps
b)
Equipment – utilities – surroundings
c)
Prior–subsequent links in the food chain
7.4.2. 7.4.2.3. 3.
Permis Permissib sible le leve levels ls of the the hazard hazard in the the end product defined in compliance with legal / customer requirements, and the intended use (Records)
7.4.3.
Hazard assessment To identify which hazards are of such such a nature that their elimination or reduction and control is essential. Including: •
•
Likely occurrenc occurrence e Severity of the adverse health effects
Methodology described and results recorded
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CHECKLIST AUDIT ISO 22000
Conformance Clause 7.4.4.
Requirement Selection and assessment of control measures Identified & document control measures that are to be applied, selected from the control measures measures defined in 7.3.5.2. Categorized in General Control Measures (managed through PRPs) or Specific Control Measures (related to CCP’s), regarding to:
a)
Effect on identified food safety hazards relative to the intensity applied
b)
Feasibility for monitoring
c)
Place within the system relative to other control measures
d)
Likelihood of failure in the functioning
e)
Severity of the consequence
f)
Specifically to eliminate/reduce the level of the hazard(s)
g)
Synergistic effects Methodology of categorization documented and results recorded
8.2.
Validation of control measure combinations Prior to implementation and after any change of General/Specific Control Measures, ensure that:
a)
Associate hazards are effectively controlled
b)
End Products meet the defined acceptable levels If a) a) / b) are are failed failed ► modifi modificat cation ion & rereassessmen assessmentt of:
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•
Control Control measures measures
•
Raw materials
•
Technologies
•
Product characteristics
•
Distribution
•
Intend of use
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CHECKLIST AUDIT ISO 22000
Conformance Clause 7.6. 7.6. 7.6.2. 2.
Requirement ESTABLISHING HACCP Plan Iden Identi tifi fic catio ation n of CCPs CCPs
Hazard to be controlled by specific control measures ►CCP (7.4.4.) 7.6. 7.6.3. 3.
Dete Determ rmin inat atio ion n of cri criti tica call limi limits ts
For the monitoring of each CCP Requiremen Requirements ts of legislation legislation – regula regulatio tions ns – intern internal al risk analy analysis sis – clients are met In terms of measurable parameters supported by instructions, specifications, education/training. Selection documented 7.6. 7.6.4. 4.
Moni Monito torring ing of the the CCPs CCPs
A monitoring system for effective and efficient control of CCPs (measurements relative to the critical limits) established and maintained Procedures + instructions + records including: a)
Measurements that provide results within an adequate time frame
b)
Monitoring devices identified
c)
Calibration methods (8.3.)
d)
Frequency
e)
Responsibility & Authority
f)
Records / methods
8.3.
Control of monitoring and measuring
To ensure valid results (if necessary), measuring equipment have to be controlled: a)
Calibrated / verified against measurement standards; where no such standards exist, the basis used shall be recorded
b)
Adjusted or or re-adjusted as as necessary
c)
The calibration st status identified
d)
Safeguarded
e)
Protected from damage Records of calibrations If no conforman conformance ce ► assess assess the the validity of previous results + treatment of the equipment / product. Records Suitability of software confirmed: prior to initial use + reconfirm
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CHECKLIST AUDIT ISO 22000
Conformance Clause 7.6. 7.6.5. 5.
Requirement Acti Action ons s when when mon monit itor orin ing g res resul ults ts exceed critical limits
7.10.
CONTROL OF OF NO NONCONFORMITY
7.10.1.
Corrections A procedure to:
a)
Identify & assess of affected end products
b)
Review the corrections carried out Approved by the responsible responsible person Records with information on the nature of the nonconformity, cause, consequence and traceability
7.10 7.10.2 .2..
Corr Correc ecti tive ve acti action ons s (CA (CAs) s) Data derived from the monitoring of PRPs + CCPs evaluated by designated person to initiate corrective actions Initiated Initiated when critical critical limits are exceeded or lack of conformity with PRPs. Records A procedure to:
a)
Review NCs (complaints included)
b)
Review trends
c)
Determine ca c ause of NCs
d)
Evaluate the need for CAs
e)
Determine and implementing CAs
f)
Records of CAs
g)
Reviewing CAs
7.10 7.10.3 .3..
Hand Handli ling ng of of poten potenti tial ally ly uns unsaf afe e prod produc ucts ts
7.10.3 7.10.3.1 .1
NCs NCs produc productt don´t don´t enter enter the food food chai chain n unless it is possible to assure that the hazards have been reduced to acceptable levels, and the product is safe All lots of products affected by NC NC identified and controlled until they have been evaluated A procedure with responses responses + authorization + actions and controls
7.10 7.10.3 .3.2 .2
Eval Evalua uatio tion n for rel relea ease se Product is released as safe when:
a)
Others evidence indicates that the control measures have been effective
b)
Combined effect of the control measures has been effective
c)
Analys lysis (or other verif erifiication activi ivities ies) indicate that the product is safe
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CHECKLIST AUDIT ISO 22000
Conformance Clause
Requirement
7.10.3.3. 7.10.3.3. Dispositio Disposition n of nonconfor nonconforming ming products products Products not acceptable for release release have to be: a)
Reprocessed to t o ensure that the hazards are controlled
b)
Destroyed
7.9.
TRACEABILITY SYSTEM
Identification of product lots and their relatio relation n to batche batches s of: •
•
•
raw materials (from the immediate suppliers) processing distribution records (to the immediate distributors)
Records maintained for a defined period Meet customers and regulatory requirements. Based on the shelf life 7.10.4.
WITHDRAW AL ALS
To facilitate a recall: a) b)
Authority & Responsibility appointed by top management Procedure for: •
•
•
Notification Handling of recalled products as well as involved products still in stock Defining the sequence of actions
Recalled products held under supervision until their treatment Records with the cause, extent and result of a recall. Reported to the top management as input to management review (see 5.8.2). Effectiveness of the programme recall verified. Records 5.7.
Emergency preparedness and response Procedures to manage potential emergency situations established by Top management
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CHECKLIST AUDIT ISO 22000
Conformance Clause 7.8.
Requirement Verification planning Establish, document & implement procedures for verification of the HACC HACCP P system system:: purpose purpose – metho methods ds – freque frequenci ncies es – respon responsib sibili ilitie ties s – record records s Shall to confirm that:
a)
The PRPs are implemented
b)
The hazard analysis is continually updated
c)
The operational PRPs and the elements within the HACCP plan are implemented and effective
d)
Hazard levels are within identified acceptable levels Records communicated to the FST NCs results in test samples of end products products ► affected affected lots lots handled handled as potentially unsafe
8.4.2.
Evaluation of individual verification results Are evaluated systematically systematically by the FST NCs with the planned arrangements arrangements ► actions to achieve conformity. Review:
a)
Procedures and communication channels (5.6. / 7.7.)
b)
Conclusions of the hazard analysis / operational PRPs / HACCP plan
c)
PRPs
d)
Human resources / Training
8.4.3.
Analysis of results of verification activities Are analysed by the FST, FST, including the results of internal & external audits, in order to:
a)
Confirm that FSMS meets the planned arrangements
b)
Identify the need for updating / improving the FSMS
c)
Identify trends
d)
Establish information for planning internal audits
e)
Confirm effectiveness of correct io ions & CAs Records reported Top Management. Input to the management review and for updating the FSMS
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CHECKLIST AUDIT ISO 22000
Conformance Clause
8
Requirement
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VALIDATION, VERIFICATION AND IMPROVEMENT OF THE FMS
8.4.
FSMS VERIFICATION
8.4. 8.4.1. 1.
Inte Intern rna al audit udit Documented procedure that defines respon responsib sibilit ilities ies – report reporting ing - record records s To determine whether FSMS system:
a)
Confo onform rms s wit with h th the pla plann nned ed arrangements
b)
Is effe effect ctiv ivel ely y imp imple leme ment nted ed and and maintained Audit programme planned: considers considers status, importance importance of processes processes and areas to be audited, and results of previous audits Criteria, scope, frequency and methods defined Objectivity and impartiality of auditors Corrective actions carried out on time by responsible for the area Verification of actions recorded
8.5.
IMPROVEMENT
8.5. 8.5.1. 1.
Cont Contin inua uall impr improvem ovemen entt FSMS continually improved through: communica communication tion (5.6.) (5.6.) – managemen managementt review review (5.8.) (5.8.) – intern internal al audit audit (8.4.1.) (8.4.1.) – evaluation of individual verification results results (8.4.2.) (8.4.2.) – analysis analysis of result results s of verificatio verification n activities activities (8.4.3.) (8.4.3.) – validation validation of control measure combinations combinations (8.2.) (8.2.) – CCAA (7.10.2.) (7.10.2.) – FSMS FSMS updatin updating g
8.5. 8.5.2. 2.
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Updat pdatin ing g the the FSMS SMS FST evaluate the FSMS at planned intervals, and if it is necessary review the HA, PRP(s) and HACCP plan Consider:
a)
Communication (5 (5.6)
b)
Suita Suitabi bilit lityy-ad adeq equa uacy cy-e -eff ffec ecti tive vene ness ss of FSMS
c)
Analy Analysi sis s of resu result lts s of veri verifi fica cati tions ons activities (8.4.3.)
d)
Manag anagem emen entt revie eview w (5.8 (5.8.2 .2)) Updating of FSMS recorded and reported : input of management management review review (5.8.2)
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