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Checklist · QC-AUD-CHK-001
Internal QA Audit Checklist
23 checkpoints across 7 sections. Per annual audit programme; minimum once per year per process; before external audits
23 Checkpoints
7 Sections
Annual minimum; more often for high-risk processes
Internal Auditor, QA Manager

Checklist Preview

S.No.CheckpointIS RequirementStatus
A. AUDIT PLANNING AND PREPARATION
A1Audit programme issued covering all key processes; frequency at least annual
Acceptance: Annual programme approved by management; risk-based frequency; all processes covered ≥1/yr
Cl. 9.2.2 — Audit programme
OK
NC
NA
HOLD
A2Auditor independent from auditee process; competence (training/experience) documented
Acceptance: Auditor not own process; ISO 9001 lead auditor cert or equivalent; CV on file
Cl. 5.4.2 — Auditor competence
OK
NC
NA
HOLD
A3Audit plan issued ≥7 days before audit; criteria, scope, team, schedule defined
Acceptance: Plan signed by lead auditor; auditees notified; opening meeting scheduled
Cl. 6.3 — Audit planning
OK
NC
NA
HOLD
B. DOCUMENTATION AND RECORDS REVIEW
B1Quality manual / project QA plan current and approved; revisions controlled
Acceptance: Latest revision in use; superseded copies withdrawn; approval signatures present
Cl. 7.5.3 — Document control
OK
NC
NA
HOLD
B2Inspection and Test Plan (ITP) maintained for each major activity; signed off by all parties
Acceptance: ITP per work package; hold/witness/review points marked; consultant signoff
Cl. 8.5 — Production controls
OK
NC
NA
HOLD
B3QA records (RFI, RFA, NCR, calibration, MTC, test reports) filed and retrievable
Acceptance: Sample 5 records from each register: all retrievable in <5 minutes; complete and signed
Cl. 7.5.3 — Records control
OK
NC
NA
HOLD
B4Calibration register current; instruments within calibration validity
Acceptance: Register up to date; spot-check 5 instruments — calibration certs valid <12 months
Cl. 7.1.5.2 — Measurement traceability
OK
NC
NA
HOLD
C. PROCESS EXECUTION AND CONTROL
C1Site processes follow approved method statements; deviations documented
Acceptance: Method statement available at workface; supervisor familiar; deviations approved
Cl. 8.5.1 — Production controls
OK
NC
NA
HOLD
C2Hold-points and witness-points respected; RFI raised before proceeding
Acceptance: No work past hold-point without inspection; sample 3 hold-points — all RFI on record
Cl. 8.6 — Release controls
OK
NC
NA
HOLD
C3Material traceability maintained: batch numbers from supplier through use in works
Acceptance: Sample 3 elements: batch numbers traceable to MTC and to receiving register
Cl. 8.5.2 — Identification and traceability
OK
NC
NA
HOLD
C4Subcontractor / vendor performance monitored; evaluation records on file
Acceptance: Vendor evaluation form completed semi-annually; weak performers on improvement plan
Cl. 8.4.2 — Type and extent of control
OK
NC
NA
HOLD
Showing 11 of 23 checkpoints ·
A. AUDIT PLANNING AND PREPARATION
A1Audit programme issued covering all key processes; frequency at least annual
Cl. 9.2.2 — Audit programme (ISO 9001)
Annual programme approved by management; risk-based frequency; all processes covered ≥1/yr
OKNCNAHOLD
A2Auditor independent from auditee process; competence (training/experience) documented
Cl. 5.4.2 — Auditor competence (ISO 19011)
Auditor not own process; ISO 9001 lead auditor cert or equivalent; CV on file
OKNCNAHOLD
A3Audit plan issued ≥7 days before audit; criteria, scope, team, schedule defined
Cl. 6.3 — Audit planning (ISO 19011)
Plan signed by lead auditor; auditees notified; opening meeting scheduled
OKNCNAHOLD
B. DOCUMENTATION AND RECORDS REVIEW
B1Quality manual / project QA plan current and approved; revisions controlled
Cl. 7.5.3 — Document control (ISO 9001)
Latest revision in use; superseded copies withdrawn; approval signatures present
OKNCNAHOLD
B2Inspection and Test Plan (ITP) maintained for each major activity; signed off by all parties
Cl. 8.5 — Production controls (ISO 9001)
ITP per work package; hold/witness/review points marked; consultant signoff
OKNCNAHOLD
B3QA records (RFI, RFA, NCR, calibration, MTC, test reports) filed and retrievable
Cl. 7.5.3 — Records control (ISO 9001)
Sample 5 records from each register: all retrievable in <5 minutes; complete and signed
OKNCNAHOLD
B4Calibration register current; instruments within calibration validity
Cl. 7.1.5.2 — Measurement traceability (ISO 9001)
Register up to date; spot-check 5 instruments — calibration certs valid <12 months
OKNCNAHOLD
C. PROCESS EXECUTION AND CONTROL
C1Site processes follow approved method statements; deviations documented
Cl. 8.5.1 — Production controls (ISO 9001)
Method statement available at workface; supervisor familiar; deviations approved
OKNCNAHOLD
C2Hold-points and witness-points respected; RFI raised before proceeding
Cl. 8.6 — Release controls (ISO 9001)
No work past hold-point without inspection; sample 3 hold-points — all RFI on record
OKNCNAHOLD
C3Material traceability maintained: batch numbers from supplier through use in works
Cl. 8.5.2 — Identification and traceability (ISO 9001)
Sample 3 elements: batch numbers traceable to MTC and to receiving register
OKNCNAHOLD
C4Subcontractor / vendor performance monitored; evaluation records on file
Cl. 8.4.2 — Type and extent of control (ISO 9001)
Vendor evaluation form completed semi-annually; weak performers on improvement plan
OKNCNAHOLD
Showing 11 of 23 ·
Inspection Sign-Off
APPROVED
APPROVED WITH CONDITIONS
REJECTED — NCR RAISED
Remarks
Name / Sign / Date
Inspected By
Name / Sign / Date
Reviewed By
Name / Sign / Date