Professional Documents
Culture Documents
Training TO Internal Auditors
Training TO Internal Auditors
Audit
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.
FDAs 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.
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
Be Punctual
Dont shout
Dont run
Dont 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 Dont assume on opinions versus fact that what you saw
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
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
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
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. Dont obstruct and dont 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,
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
Dispensing
Testing
CAPA
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.
54/A2. The self inspection should be completed within the scheduled date.
Self inspection log is maintained as per CQA-54/A1 .
15 days of
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
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 .
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.
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?
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