1. A QUALITY IMPROVEMENT TOOL
AUDITING
A QUALITY IMPROVEMENT TOOL
NOVEMBER 18 ,2015
Joel Schwartzman
Retired

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3. Audit Purpose
The purpose of quality auditing is to examine the effectiveness of management directed control programs.
The philosophy of quality assurance programs is based on prevention rather than detection of problems.

4. Audit Scope The Client determines the audit scope
The Client may be, for example, the purchasing director, the research manager, the quality manager or the FDA District Director.

5. Audit objectives can be based on:
Management priorities or system requirements
Statutory, regulatory and contractual requirements
A need for provider evaluation
Risks to the organization
Whatever the boss dictates

6. AUDITING MISTAKES - Auditing with the “gotcha” attitude
Finding faults and not facts
Not recognizing that the audit is people focused
Not properly defining the purpose and scope
Not using a quality audit checklist
Not issuing corrective action
Not conducting follow-up on the corrective action
Not using a team approach in reviewing corrective actions

7. AUDITS CONSIST OF
Interviews
Data Review

8. Audit Preparation Learn about the provider
Talk to people who deal with the provider
Review complaints
Review receiving reports
Review contract
Review audit standard- GMP, ISO
Determine the audit focus

9. WHAT PERSONALITY TYPES
AUDITORS
WHAT PERSONALITY TYPES
ARE AUDITORS?

10. Who to Audit QC Lab/Inspection/ Engineering Purchasing
Production operators
Receiving/Shipping
Calibration Lab
Document Control
R&D/ Engineering
Management

11. Interviewing Techniques
Open ended questions
Probing
Silence
Pauses
Paraphrasing

12. DATA REVIEW Calibration Records Training CAPA Document Control
Design Control
Purchasing procedures
Complaints
Internal audits
Receipt records
Batch Records

13. WHAT TO ASK
Each area has specific questions that need to be addressed

14. TOP MANAGEMENT How does management show commitment to quality
Is there a current organization chart
How are quality objectives established at various levels
How are objectives measured and communicated

15. QUESTIONS CALIBRATION Is there an effective plan
Are there documented procedures
Are calibrations traceable to NIST ( in the United States)
Is the equipment labeled
Is non-calibrated equipment isolated
Are personnel trained
Are the reference standard calibration certificates available
Are R&R studies available

16. QUESTIONS INTERNAL AUDITS Is there a procedure Is there a schedule
Have the scheduled audits been performed and are there reports
Are the audits conducted by trained personnel
Have the non-conformances been investigated

17. QUESTIONS
COMPLAINTS
Is there a procedure to record and investigate complaints
Are complaints applicable to other products
Who are members of the investigating teams

18. QUESTIONS INSPECTIONS
Is there procedures for incoming, in-process and final products
Is the data recorded, maintain and trends reviewed
Are there control plans for each product
What sampling plan is used, AQL’s
Are there calculated CpK’s for each product
Are control charts available for key measurements
Is there a process flow chart available for each process
Is there a preventative maintenance program

19. QUESTIONS TRAINING Are employees trained for their specific jobs
Are records maintained and by whom
Who conducts the training
Are there job descriptions
Is there new employee training
Is there evidence of periodic personnel reviews

20. QUESTIONS
CAPA
Is there a procedure to collect, record, investigate and report findings
Are root causes investigated
Has preventive action been taken.
Have investigations been done to determine effectiveness of the CAPAs implemented
Are findings investigated for similar processes or products
Are non-conforming products identified and segregated.
Who are members of the CAPA team investigations

21. QUESTIONS DOCUMENT AND RECORDS CONTROL
Are there procedures to prepare, review and distribute new documents
Are there procedures to remove obsolete procedures.
How are procedures made available to those that need to use them
How are employees made aware of what is the current revision
How are records stored and protected from deterioration

22. QUESTIONS DESIGN CONTROLS Are design reviews conducted and by whom
How are customers needs determined
How are customers needs turned into requirements (specifications}
Is there a procedure for design changes and modifications
Who reviews and approves the changes

23. QUESTIONS PURCHASING CONTROLS Is there an approved provider list
How are responsible personnel (providers, qc, production) made aware
of spec changes.
Who are members of the provider audit teams
Are providers issued report cards
Do contracts contain a statement that the customer can audit the
provider  

24. COMPLETING the Audit All observations (findings) should be:
- Documented
- Reviewed
- Clear and Concise
- Supported by evidence
- Acknowledged by the auditee

25. THAT’S ALL FOLKS