Quality improvement. Most feedback is as a result of failure (PARETO, customer
comments, inspection). Audits allow prevention to take place.
External input (can't see the wood for the trees).
By pass the chain of command.
Provide management with information that they would not normally receive.
Definition(BS 7229):
A systematic and independent examination to determine whether quality
activities and related results comply with planned arrangements and whether
these arrangements are implemented effectively and are suitable to achieve
objectives.
Types of audit:
Internal, external and extrinsic.
Systems or compliance(process).
Full, partial or follow up.
Static or dynamic.
Regular or ad hoc.
Check lists:
Departmental for systems.
Criteria for process.
Questions.
Recording.
Conducting an audit:
Planning:
Read/understand the regulation/standard (external documentation).
Read/understand the WTI's/WI's (internal documentation).
Prepare questions.
Agree time and place of audit with sect/dept head.
Performance:
Be friendly and helpful.
Make short observations and stick to the audit.
Quote WI's, WTI's, QA regulations and standards in this order.
Either 1 conformance report for the whole audit (full conformance) or separate
non conformance reports for each non conformance.
Sect/dept head is to state any corrective action including agreeing date
of follow up audit.
Reporting: Use the audit report as shown in the WI.
