1 Quality

ConocoPhillips China

China National Offshore Oil Co

How to Survive an Audit S. Scott Sittner

ANSI-ASME Certified Lead Auditor, Certified Auditor Trainer, Chief Engineer, Quality Point of Contact

China Offshore Oil Engineering Co

Tanggu Fabrication Yard

Tanggu, China

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Why is product Quality important?

Accountability is a Mandate of Law.

It takes a long time for a company to build up a reputation for reliability, and only a short time to be branded as "unreliable."

Continual evaluation of product reliability and ongoing control of Quality are critical necessities in today's competitive business arena.

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Bohai-Penglai Quality Road Map

We have considerable

expectations placed

upon us.

This Road Map

illustrates some of the

requirements we are

expected to meet.

QA Road MapQA Road Map

Project Quality Project Quality

AssuranceAssurance

Implementing ProceduresImplementing Procedures

Contract

Clauses

Project ProceduresProject Procedures

International Law

Desk InstructionsDesk Instructions

Client QA Program

ISOISO

Technical

Specifications

Regulatory

Guides

Internal Audits

Process

ImprovementsC A N

W E

D O IT

B ETT ER

?

Management Assessments

g o o d

Ex c e lle n t

p r o b le m !

G o o d

C ould be

be t te r

O U TSTAN D IN G

GuidesGuides

External Audits

Industry Baseline

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An Audit Is

A documented activity, performed in accordance with written procedures or checklists to verify, by examination and evaluation of objective evidence, that applicable elements of the Quality Program are effectively implemented per specified requirements.

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An Auditor Will

Find out what you are doing.

Analyze what you did.

Evaluate what you did.

Record your response.

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Before the Audit You Should

Prepare for the Audit.

Review all pertinent procedures.

Review what you are required to do according to procedure.

Determine the scope of the Audit and inform necessary participants.

Review old Audit Reports.

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During the Audit You Should

Take Notes.

Let the Auditor set the pace and direction of the interface.

Be cooperative.

Minimize disruption.

Verify your information.

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During the Audit You Should

Do not say, “I don’t know.”

Rather refer the Auditor to a person who knows.

Provide feedback to Management.

Solicit the Auditor’s thoughts.

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After the Audit You Should

Meet with the Auditor(s)

Listen to the findings.

Respond – Clarify any misunderstandings and correct errors.

Request a draft written statement of any findings.

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If possible you should.

Permit the auditor an opportunity to propose corrective actions.

Attempt to get a commitment from the Auditor regarding corrective action proposals.

Find out the issue date of the formal report and your response time.

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Sample Auditor Questions

1. What procedure governs your activities? 2. What kind of documented training have you had to do your

job? 3. How often are proficiency evaluations performed? 4. What activity do you perform that affects QA? 5. Where is a copy of your last audit? 6. Does your group maintain any controlled documents? 7. How is your training documented? 8. Where is your master list of procedures? 9. How do you handle major changes? 10. What do you do if you find a problem which needs fixed?

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Sample Auditor Questions 11. How do you preserve records? 12. Show me the procedure you use to preserve records. 13. Are you aware of Quality Objectives? 14. I would like to see the evaluation of performance of a

particular supplier over a period of time. 15. Can you pull one up? 16. Who assures the performance on other suppliers? 17. How would I know if the suppliers are satisfactory? 18. What statutory/regulatory requirements do you have and how

are they handled?

19. What measures do you have in place to tell if the job is performed right?

20. Explain your office/area activities.

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Traditional Audit Process Steps 1. QA Manager Selects a qualified Lead Auditor as the Audit Team Leader (ATL).

2. ATL Schedules the audit verbally or telecon and notifies the audited organization in writing of the scope, audit team (AT) makeup and proposed audit dates.

3. Engineering Provide technical input relative to products or services for external audits.

4. Engineering Provide critical characteristics of commercial grade items for commercial grade surveys.

5. ATL Initiates an Audit Plan

6. QA Manager Approves the Audit Plan.

7. ATL Provides an orientation to the audit team members including: Scope of the audit, Lines of communication to be used by the audit team, Pertinent policies, procedures, standards, instructions, codes and regulatory requirements, Results of prior audit reports, Audit checklist to be used.

8. ATL Signs the audit plan indicating completion of team orientation.

9. ATL Provides detailed checklists delineating procedural requirements, follow-up items and requirements unique to the organization being audited. Note: For commercial grade surveys the checklists shall include functional areas of the suppliers documented quality program necessary to control the acceptability of the critical characteristics identified by Engineering.

10. ATL Conducts a pre-audit conference with management of the audited organization addressing: Confirmation of audit scope, Items to be audited, Introduction of the audit team and identification of their corresponding counterparts, Establishment of communication channels, Establishment of daily audit schedule. Sample Questions: General

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Traditional Audit Process Steps

11. ATL/AT Conducts the audit in accordance with the checklist provided. Note: The checklist questions or format should not prevent the auditors from examining applicable processes or problems found outside the specific scope of the checklist question, to their successful conclusion.

12. ATL/AT Examines objective evidence to the depth necessary to determine acceptable implementation and compliance with QA program requirements and records the documentation reviewed in the audit checklist.

13. ATL/AT Identifies deficiencies on Audit Finding Reports (AFR), for external audits, and on Corrective Action Reports (CARs), in accordance with the procedural “Corrective Action Process” for internal audits. The deficiency shall be documented in sufficient detail to assure that corrective action can be effectively carried out by the audited organization.Notes: For internal audits, no further action is required other than CAR initiation. For Commercial Grade Surveys, AFRs are only initiated when implementation is not in accordance with the written quality program requirements. Quality requirements not acceptably implemented by the supplier, but not required by the supplier’s quality program, are addressed by contractually imposed conditions/restrictions.

14. ATL/AT Investigates the cause and effect of identified AFRs to determine the extent of the corrective action needed.

15. ATL Notifies the audited organization immediately of any conditions determined to require immediate corrective action.

16. ATL Conducts a post-audit conference at the conclusion of the audit to present the results, identify deficiencies, and clarify any misunderstanding or questions.

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Traditional Audit Process Steps

17. ATL Documents the results of the audit in an audit report that provides the following information:a) Date of audit and pre and post-audit conferences,b) Description of the audit scope,c) Identification of the auditors,d) Identification of persons contacted during pre and post audit conferences and audit activities,e) A summary of the audit results, including an evaluation statement regarding the effectiveness of the quality assurance program elements that were audited,f) A summary description of each identified deficiencies.g) A description of any conditions or restrictions required to compensate for Identified deficiencies.

18. ATL Issues an ATL signed copy of the audit report to the QA Manager allowing sufficient time for approval within 30 days of the post-audit conference.

19. QA Mgr. Approves and signs the audit report, within 30 days of the post-audit conference, and the Evaluation of Supplier Quality Form.

20. QA Admin Distributes the audit report to the management of the audited organization as follows: External Audits QA Manager Appropriate Supplier Quality Assurance Representative Managers of Projects, Fab/Construction and/or Engineering, as applicable to the work. Internal Audits President, Vice-President, Cognizant Managers

21. ATL Performs follow-up for identified AFRs to assure the receipt of a written response within 30 days of issuance of the audit report.

22. ATL Reviews the AFRs to determine the adequacy of the response, including cause and the corrective action to prevent recurrence, and that corrective action is identified and scheduled for each finding.

23. ATL Contacts the audited organization if no response is received within 30 days and establishes a new due date.

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Traditional Audit Process Steps

24. ATL Verifies that acceptable corrective action has been implemented by review of supplied documentation or re-audit, as appropriate to the identified deficiency.

25. ATL Signs the AFR and routes the AFR to the QA Manager for approval.

26. QA Mgr. Reviews and approves the AFR.

27. QA Admin Files audit records and completed AFRs in accordance with procedure.