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Auditors: Auditees:
Availability of necessary approved & controlled documents to be verified for each activity.
Availability of supporting records to be verified in each activity. Also they must be signed off by authorised person.
All clauses to be audited for each department.
Any NC and improvement potential to be recorded against the respective question.
Proper evidence must be recorded for all audit questions.
Mj - Maojr NC, Mn - Minor NC, OI - Opportinity for Improvement, O+ - Compliance
Have all external audit NCs, Customer audit NCs and IQA NCs been
1 9.2.2 QSP-IA
effectively closed?
3 Is risk analysis carried out? Are there any actions for reducing the risks? 6.1 QSM-6.1
Are the drawings, control plans and other documents of latest products QSM 7.5, DM-
4 7.5.2, 7.5.3
available with QA? QA, QSP-DRC
Verify product audit and process audit plans vs actual and product audit 9.2.2.3,
DM-QA-PFC-04,
10 9.2.2.4, 8.7,
report (at every stage ). Are CAPA available for the observations? 10.2
DM-QA-PFC-01
8.5.6, 8.5.6.1,
QSM-8.5, QSM-
17 Are 4M changes (permanent & temporary) controlled in shopfloor? 8.5.6.2, 8.5.2,
7.4
8.5.2.1, 7.4
Are non-conforming products & suspected products effectively controlled? 8.7, 8.7.1, DM-QA-PFC-06,
8.7.1..2,
18 Are customer / HOD-QA approvals available for deviations? Are the 8.7.1..3,
DM-QA-PFC-13,
defective parts properly disposed? 8.7.1.6, 8.7.1.7 QSP-NCP