internal audit

TRAINING TO INTERNAL AUDITORS

Audit

“A systematic and independent examination to determine whether quality related activities and their results comply with documented systems, are effectively implemented and are suitable for achieving the quality objectives. ”

 “ Every audit is unique due to the auditor and auditee and its varies by personal judgment, past experiences, auditing style , basis perceptions, opinions , culture value systems, personalities and management style. ”

Principles of Audit : Independence: Auditor must be independent of the activity being audited. They must remain free from bias and conflicts of interest Evidence: Audit evidence must be verifiable and on sample basis.

Types of Audits :  First Party : An audit by the organization of its own systems and procedures. (Internal Audit / Self inspection)  Second Party /External :An audit conducted by its supplier/customer.  Third Party :An audit by a body which is commercially and contractually independent of the organization, its suppliers and customers.

FDA’s REQUIREMENT  In order to verify compliance with the principles of GMP, regular internal audits should be performed in accordance with an approved schedule.  Audit findings and corrective actions should be documented and brought to the attention of responsible management of the firm. Agreed corrective actions should be completed in a timely and effective manner.

Internal Audit means , It is a check to ensure that the quality management systems are operating effectively in accordance with the established standards. To update and ensure implementation of SOPs/Policies across the organization as per approved quality system. To Review, analyze and evaluate the present technical documents in the light with regulatory guidelines and current industry practices and approved procedure.

Keys for effective internal Audits : 1.0 Independence 2.0 Staffing and Training 3.0 Audit Planning 4.0 Relationships 5.0 Due Care 6.0 Evaluation of the internal control system 7.0 Evidence 8.0 Reporting and follow-Up

Keys for effective internal Audits : 1.0 Independence : The internal auditors should be a independence in term of organisational status , department and personal objectives. 2.0 Staffing and Training : The internal audit teams should be appropriately staffed in terms of numbers, qualifications and experience, having regard to its responsibilities and objectives. The internal auditor should be properly trained to fulfil all his responsibilities

Keys for effective internal Audits : 3.0 Audit Planning :  Be ready with audit agenda, check-lists etc.  Be punctual and to the point.  Follow the required entry/exit procedure Audit objective, Audit Scope and Audit team should defined

Keys for effective internal Audits : Audit Checklist :checklist.tif Advantages:  Guide to auditors for samples, time.  To control the depth of the audit  To control the pace of the audit  It helps to ensure that audit area is covered completely – Nothing is missed. Disadvantages:  May restrict for analysis of problem in depth.  May prevent the auditor from investigating significant incidents simply because they were not on checklist

Keys for effective internal Audits : 4.0 Relationships: Internal audit can be performed properly , when auditors has confidence in auditee. 5.0 Due Care : To demonstrate the due care , the internal auditor should be able to show that his work has been performed in a way which is consistent with regulatory requirements. The internal auditor should possess a thorough knowledge of the aims of the organisation and the internal control system. 6.0 Evaluation of the internal control system : To ensure compliance with statutory requirements.

Keys for effective internal Audits 7.0 Evidence : The collection and assessment of internal audit should be recorded and reviewed to provide reasonable assurance that conclusions are soundly based and internal audit objectives achieved. 8.0 Reporting and follow up :The internal auditor should ensure that findings, conclusions and recommendations arising from each internal audit assignment are communicated promptly to the appropriate level of management and it is implemented .

Qualities of an Effective Auditor An auditor need to be….  Educated , Open minded, Experience ,and

       

Competent Diplomatic (Tactful in dealing with people) Observant (Aware of physical surroundings) Perceptive (Understand the situations) Decisive (Timely conclusion based on logic) Self-reliant (Interact but function independently) Firm (Persistent, focused) Honest Professional Approach

Do’s and Don'ts

Be Punctual

Stop and Listen carefully

Do not interrupt to auditee

Don’t run

Don’t shout

Don’t argue

Responsibilities of auditors  Auditor should remain polite, calm and professional at all            

time. Introduce with the purpose/scope Keep to agenda Keep control (never talk down) Listen to others Speak clearly and carefully Stay within the audit scope. Communicate the audit requirements. Collect evidence (for and against) Document non-compliances. Verify the corrective actions/compliances Give compliments/Appreciate for good things Don’t assume on opinions versus fact that what you saw

Auditor Should be Prepared  Unsystematic and unfocussed approach  Negative feelings and opinions about audits in       

the minds of auditee. Planned during wrong period Extended beyond defined scope Aggressive auditees Less talking auditees Missing people Missing documents Special cases Emotional blackmail

What Auditor should look for ….?                  

Personnel: Health and hygiene. Storage of Materials Receipt Procedures Man and Material flow Testing Production , Packing and process controls Systems and procedures Qualifications and Validations Facility Deviation Change control Risk assessment Rejects and refusals Complaints Investigations Calibrations Environmental conditions Training

But not limited.

Techniques of Audits: 1. Collect and verify the information 2. Observations 3. Interview 4. Record review ( Document , process and Product review ) 5. Tracking

Case Study

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Picnic Rainy season Car Village Prince Black Horse Jungle Palace Coffee Temple Journey

Techniques of Audits: 1.0 Collect and verify the information. Collect and Verify documents ,records , procedure , specification , log books and drawing. 2.0 Observation :  Observed the activity. Don’t obstruct and don’t stare.

Techniques of Audits: 3.0 Interview :  Ask-open-ended question .  Ask-Closed ended question .  Question techniques : When, where ,Who , How , show me  Interview the person while performing the activity at workplace.  Leading questions should be avoided.  Do not conclude by yourself on assumption  KEEP EYES AND EARS OPEN (Learning , Attending ,Understanding,

Concentrating ,Remembering and Continually grasping and processing information )  Results from the interview should be summarized and any findings should be

verified.  Every attempt should be made to give ease to the person .

Techniques of Audits: 4.0 Record review ( Document , process and Product review )  Ask questions, review records and procedures.  Give auditee a chance to explain and defer situations to the audit team leader. 5.0 Tracking  If a problem is found, check requirements , procedure and standards , notify the audit leader , assess the impact on the product and recommend to management to stop the production or process. Eg :

Complaints

Packing Batch records 

Dispatch

Dispensing Manufacturing

Deviation

Testing

Investigation OOS/ OOT

CAPA

RAW /Packing material  RECEIPT Approved Vendor

Audit report        

State decision and conclusion Summarize positive and good points Explain major , minor and critical non-compliances. Explain the findings and evidences carefully and precisely. Stress confidentiality. Review on-line compliances if any. Give recommendations for improvements THANK THE AUDITEES

Self inspection Composition of self inspection :  There should be minimum two inspectors , including one from Quality Assurance.  Self-inspection team members should be independent from those having direct responsibility for the areas being inspect.  Team consists of qualified, experienced senior personnel who can evaluate the situation objectively. There should not be any conflict of interest before carrying out the self-inspection.

 Procedure for Self inspection :  All the areas should be covered under self-inspection at least twice a

year or whenever required.  The self-inspection schedule is made by Quality Assurance CQA-

54/A2. The self inspection should be completed within the scheduled date.

15 days of

 Self inspection log is maintained as per CQA-54/A1 .  A Self inspection number is issued by Quality Assurance department

on individual self inspection report as follows SIRI$$/@@ Where, SIR - Self inspection report $$ - last two digits of the Current Year Serial number starting from 01  Annexure CQA-54/A4 should be filled separately for each non

compliance recorded as per specimen Annexure CQA-54/A3.

Report Finding : Non compliances are classified into “Critical”, “Major” and “Minor” .  Critical : Non-conformances, which have direct impact on the quality of the product.  Major : Non-conformances which may have indirect impact on quality of the product.  Minor : Non-conformances which may not have impact on quality of the product.  All observations noticed during the self inspection should be submitted within 48 hrs in Annexure CQA-54/A3 .

 Inspector should discussed the non conformances points

with Head of department , Quality Assurance and Unit Head .  Investigation of each non-conformance points should be

justified in annexure CQA-54/A4 by an auditee.  Non- conformance submitted criteria :  Critical non-conformance

: Within 24 hours  Major and Minor non-conformance :Within 15 days.  Close out of self-inspection report : Within 30 days.  Trending of the self inspection findings :Six monthly

Certification of self inspector  For evaluation as a Self Inspector, an individual shall

participate in three self inspections along with experienced and certified self inspector.

 Phase l : Observer  Phase ll : Assist the experience self inspector  Phase lll : The individual under evaluation shall work

as self inspector and the activities shall be monitored by the experienced Self Inspector.

 Evaluation is carried out out during each phase by

certified self inspector as per Annexure QA-10 A26.tif .  Evaluation shall be done for each section in the department separately.  Based on evaluation Quality Assurance shall issue certificate for designated section as per Annexure QA-101A25.

Internal audit  Internal audit program help in solving problem , improvement ,root cause analysis and provides tools to capture effectiveness.  In current changing scenario of regulatory

requirements, inspection and inspection approach, there is need to strengthen Policies by internal audit to Upgrade and Harmonize Quality Policy and ensure effective implementation.

Reference    

EU GMP Guidelines Indian GMPs : Schedule M Canada Guideline Internal Audit Committee of the Malaysian Institute of Accountants from the publication "Guidance for Internal Auditors" issued in June 1990 under the aegis of the Consultative Committee of Accountancy Bodies (CCAB) in the United Kingdom.  WHO TRS -908.  Pharmaceutical Inspection Co-Operation Scheme 1 , September 2003  SOP CQA-54 and QA-10

Case Study

Internal Audit THANK YOU

ANY QUESTIONS? 6