Schniepp-Building Your Best Internal Audit Team for Quality … · 2017-10-31 · 4 W E L L N E S S...

Building Your Best Internal Audit Team forQuality Results

FDA Inspections Summit

November 3, 2017Presenter: Susan Schniepp

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W E L L N E S S F O R B U S I N E S S®

Discussion Topics

• Regulatory Requirements

• Benefits of Internal Audits

• Elements of Internal Audits

• Conducting the Internal Audit

• Audit Reporting

• Responding to the Audit

2017 © Regulatory Compliance Associates Inc.

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Regulatory Requirements


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Regulations

21 CFR 820 -- QUALITY SYSTEM REGULATIONSubpart B: Quality System Requirements,Sec. 820.20 Management responsibility

(c) Management review. Management with executive responsibility shallreview the suitability and effectiveness of the quality system at definedintervals and with sufficient frequency according to establishedprocedures to ensure that the quality system satisfies the requirements of thispart and the manufacturer's established quality policy and objectives. Thedates and results of quality system reviews shall be documented.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820

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Regulations (continued)

EudraLex, Volume 4, Chapter 1Pharmaceutical Quality System

• There is a process for self-inspection and/or quality audit,which regularly appraises the effectiveness and applicabilityof the Pharmaceutical Quality System.


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Regulations (continued)

ICH Q10 – PHARMACEUTICAL QUALITY SYSTEM

CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITYSYSTEM; Management Review of the Pharmaceutical Quality System

Management should have a formal process for reviewing the pharmaceuticalquality system on a periodic basis. The review should include:

(3) Self-assessment processes including risk assessments, trending, and audits


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Regulations (continued)ISO 9001:2000 ASQ Quality

SystemMedical DeviceGMPs

Pharmaceutical GMPs

Audits Internal audits atplannedintervals todeterminewhether thequalitymanagementsystem conforms

Internal audits ofthe quality systemat regularintervals toevaluate theeffectiveness ofthe various qualitysystem elements

Management needsto establishprocedures forquality audits of itsdocumented qualitysystem and ensurethat they areperformed

Audits are not explicitlyspecified but areembodied within therequired record reviewprocess.Annual record review toevaluate theapplicability of qualitystandards, need forchanges inspecifications,manufacturingprocesses, or controlprocedures.

https://www.fda.gov/food/guidanceregulation/cgmp/ucm110977.htm


https://www.fda.gov/food/guidanceregulation/cgmp/ucm110977.htm

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Benefits of Internal Audits


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Benefits• If designed and implemented appropriately, it can provide

valuable information for prevention of issues

• Issues are identified before regulatory/client inspections

• Issues are corrected/plan for correction before regulatory/clientinspections

• Issues are confidential/corrective actions are not

• Provides a different perspective of the organization

• Information can be used for training staff

• Communication tool for informing Executive Management


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Elements of Internal Audit Programs


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Should be:

• Partnering, team oriented

• Instructive, informative

• Open, honest, inclusive

• Scheduled, announced

• Cooperative

• Forward thinking

• Unlimited in scope


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Should not be:

• Judgmental, antagonistic

• Check box mentality

• Retrospective review

• Limited in scope

• Unannounced


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Tangible Elements• Approved audit schedule (cover critical areas within a 12 month period)

– Quality Systems

– Packaging/Labeling

– Suppliers/Materials Controls

– Facilities/Equipment

– Training

– Complaints

• Can be scheduled monthly, quarterly, semi-annually, annually based on companyrequirements

• Audit tracking log:

– Date/Scope of Audit

– Auditors

– Issue Elevation/Management Reviews

– CAPA status


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Conducting the Internal Audit


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Audit Behaviors• For Auditors:

– Be direct – don’t ask questions to purposely try and stump

– Be instructive – explain why you are requesting the information

– Be friendly – you are not the enemy, you are the partner

– Be attentive – listen to the answers and refrain from judging

– Be proactive – look at items that are infrequently assessed


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Audit Behaviors (continued)• For Auditees:

– Be direct – don’t answer questions to deflect or obfuscate an issue

– Be instructive – explain why you do things the way you do

– Be friendly – the auditor is not the enemy, the auditor is your partner

– Be attentive – listen to the concerns of the auditor and don’t react

– Be proactive – point out things of concern and ask what you can doto correct them


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Additional Considerations• Be inclusive – involve everyone in the audit

• Be innovative – try letting someone from the functional areapartner with the internal auditor

• Be collaborative – discuss possible solutions to problemsand how they can be implemented


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Audit Reporting


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Audit Reporting

• Follow SOP for timing of issuing audit reports

• Provide the appropriate regulation for your observation

• Provide possible solutions for the citation

• Confirm receipt of your findings

• Make sure your observations are understood

• Establish a deadline for receiving responses to observations


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Responding to the Audit


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Audit Responses• Follow SOP for timing of responding to audit reports

• Confirm receipt of the audit report

• Provide appropriate rationale and documentation for yourresponse

• Look for system improvements not band aids

• Make sure your responses are understood and acceptable

• Assign due dates for implementing your actions

• Track your actions until fully implemented

• Close out the audit report when all actions and commitmentshave been completed


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Summary• Internal Audits are a valuable tool for identifying issues

• Use the information to improve your processes

• Use the audit tool as another tool to train your employees

• Take the audit and the subsequent responses seriously

• Apply the resolutions systematically & broadly to functions

• Consider it more as a gap analysis for your processes


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Final Thought

“Two-thirds of the Earth's surfaceis covered with water. The otherthird is covered with auditorsfrom headquarters.”Norman Ralph Augustine (born July 27, 1935)U.S. Aerospace BusinessmanUnder Secretary of the Army from 1975 to 1977


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