A Day in the Life of an Audit Inspection Readiness Do s and Don'ts During a 3 rd Party Audit Inspection Readiness QAS-TRN-001-00, Inspection Readiness Effective Date: 01May2014 Slide 1 of 15
External Audits of BioC Why Audit Types of Audits Definitions Reasons for Audits Who is Involved in the Audit The Audit What is in Scope Behaviors (Do s & Don ts) What we Retain QAS-TRN-001-00, Inspection Readiness Effective Date: 01May2014 Slide 2 of 15
Why Audit Definition of Audit? ISO 19011 Deals With Audits A systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. Regulatory and company expectation Quality audits are an important part of a good quality system QAS-TRN-001-00, Inspection Readiness Effective Date: 01May2014 Slide 3 of 15
Types of Audits FDA Food and Drug Administration (GMP 21 CFR Part 211) DEA Drug Enforcement Administration Clients or Sponsors (Third Parties) Internal QA audits of BioC completed by our own QA group QAS-TRN-001-00, Inspection Readiness Effective Date: 01May2014 Slide 4 of 15
Definitions Common Terminology: CAPA Corrective Action / Preventive Action 483 FDA observations or findings (Form 483) Finding or Observation Not Following a Procedure, Process, or Regulation. In some cases these can be positive findings or observations, but not usually. QAS-TRN-001-00, Inspection Readiness Effective Date: 01May2014 Slide 5 of 15
Reasons for Audit General Inspection or Routine For Cause Inspection (Suspected Problem, Recall, etc.) New Start Up Client Inspections Continual Improvement Good Business Practice QAS-TRN-001-00, Inspection Readiness Effective Date: 01May2014 Slide 6 of 15
Who is involved in the Audit Reception First Contact (Should Know Procedure for Hosting an Audit) Quality Assurance Host of Auditor and Coordinator of Activities Laboratory and Laboratory Personnel Information Technology and Personnel Management (Ultimately Responsible for Audit and Findings if Any) ANY EMPLOYEE Anyone that is on the Organization Chart ANY CONTRACTORS If listed on Organization Chart or Mentioned QAS-TRN-001-00, Inspection Readiness Effective Date: 01May2014 Slide 7 of 15
The Audit What auditor expects 1. Availability of appropriate people during the audit 2. Availability of documentation 3. Knowledge of regulations, and company SOPs that apply to you 4. Clear discussion on audit findings 5. Access to appropriate areas 6. QMS in place and followed What auditees should expect 1. Clear audit agenda and scope 2. Flexibility during the audit 3. Clear communication about the audit process 4. Clear communication about the findings 5. Questions about what, how, and why 6. Daily wrap ups QAS-TRN-001-00, Inspection Readiness Effective Date: 01May2014 Slide 8 of 15
What is in Scope Predicate Rules & Regulation s Business Processes Predicate Rules & Regulations Business Processes Applicable Applicable SOPs SOPs Validation Validation Package package Risk Management Training records records Evidence Evidence QAS-TRN-001-00, Inspection Readiness Effective Date: 01May2014 Slide 9 of 15
What is in Scope cont d Computer systems are an integral part of the business process, not a separate piece of the process. Software Hardware COMPUTER SYSTEM Standard Operating Procedures Training QUALITY SYSTEMS COMPUTERIZED SYSTEM OPERATING ENVIRONMENT QAS-TRN-001-00, Inspection Readiness Effective Date: 01May2014 Slide 10 of 15
Behaviors (Do s and Don ts) Do s 1. Seek coaching from immediate management and/or QA if possible 2. Tell the truth Don t wing it 3. Be honest and open to questions 4. Answer only questions that are asked 5. If you don t know say so 6. Answer Yes or No don t continue to talk unless it s necessary 7. Paraphrase if needed clearly know what you are being asked 8. Try to resolve problems during the inspection when possible. 9. If you don t understand the questions, it s ok to ask for clarification. 10. Be consistent with your answers QAS-TRN-001-00, Inspection Readiness Effective Date: 01May2014 Slide 11 of 15
Behaviors (Do s and Don ts) Don ts 1. Don t argue 2. Don t speculate or guess 3. Don t answer open-ended questions if possible if you do be specific 4. Don t bring anything into the room unless asked 5. Don t bring the whole binder just what was asked for 6. Don t Lie 7. Don t elaborate. Keep responses simple and specific to the question. 8. Don t take anything personal 9. Don t panic if you don t know answer the question. Just state you don t know and that you will talk investigate and/or talk to your supervisor to get the answer. 10. Don t sign anything. Politely refuse and escalate to your superior for review/approval. QAS-TRN-001-00, Inspection Readiness Effective Date: 01May2014 Slide 12 of 15
What we Retain List of all audit participants Documentation checklist All correspondence with the third party inspector All meeting notes Questions/answers to/from inspectors List of documents the auditor took with them QAS-TRN-001-00, Inspection Readiness Effective Date: 01May2014 Slide 13 of 15
Questions QAS-TRN-001-00, Inspection Readiness Effective Date: 01May2014 Slide 14 of 15
Thank you. QAS-TRN-001-00, Inspection Readiness Effective Date: 01May2014 Slide 15 of 15