1. 1Quality
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
2. 2Quality
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.
3. 3Quality
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 QualityProject Quality
AssuranceAssurance
Implementing ProceduresImplementing Procedures
Contract
Clauses
Project ProceduresProject Procedures
International Law
Desk InstructionsDesk Instructions
Client QAProgram
ISOISO
Technical
Specifications
Regulatory
Guides
Internal
Audits
Process
Improvements
C A N
W E
D O IT
B ETT ER
?
Management
Assessments
good
Ex c ellent
problem!
G ood
C ould be
better
O U TSTAN D IN G
GuidesGuides
External Audits
Industry
Baseline
4. 4Quality
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.
5. 5Quality
An Auditor Will
Find out what you are doing.
Analyze what you did.
Evaluate what you did.
Record your response.
6. 6Quality
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.
7. 7Quality
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.
8. 8Quality
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.
9. 9Quality
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.
10. 10Quality
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.
11. 11Quality
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?
12. 12Quality
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.
13. 13Quality
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
14. 14Quality
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.
15. 15Quality
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.
16. 16Quality
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.