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Iso 9001

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21 Cfr 820
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Finished Goods Quality Assurance Checklist

Visual Inspection

Confirm work order and lot match the traveler

Pull the AQL sample per ANSI Z1.4

Inspect surfaces, finish, and labels for defects

Verify color and finish against the boundary sample

Write an NCR and segregate the rejected lot

Dimensional Accuracy

Pull calibrated gauges from the tool crib

Measure CTQ dimensions per the inspection sheet

Run the CMM program on first and last pieces

Confirm Cpk meets the control plan threshold

Functional Testing

Run the end-of-line functional test sequence

Verify performance against customer acceptance criteria

Conduct the hi-pot or leak test per the control plan

Verify safety interlocks and guard sensors

Route failed units to MRB for disposition

Documentation and Traceability

Record serial and lot numbers in the MES

Capture raw material heat and lot for traceability

Sign and attach the CofC and CofA

Verify release meets PPAP and ISO 9001 requirements

Packaging and Storage

Inspect packaging against the customer pack-out spec

Apply ESD or moisture-barrier protection where required

Confirm carton labels include barcode and handling marks

Stage finished goods in the FG bonded location

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ISO 9001 Compliance Checklist

Context of the Organization (Clause 4)

Document internal and external issues

Map interested parties and their requirements

Define the QMS scope and exclusions

Map QMS process interactions

Publish the context and scope document

Leadership and Commitment (Clause 5)

Hold the management commitment review

Reissue the quality policy at current rev

Cascade quality objectives to functions

Assign QMS roles and authorities

Brief supervisors on the process approach

Planning and Risk Management (Clause 6)

Run the risk and opportunity workshop

Update the QMS risk register

Refresh PFMEAs for impacted processes

Set measurable quality objectives with KPIs

Plan the QMS change-control workflow

Support and Resources (Clause 7)

Verify resource adequacy across the QMS scope

Audit the competence and training matrix

Close training gaps before audit week

Inspect calibration and infrastructure status

Audit document control and the master list

Operation and Internal Audit Readiness (Clause 8)

Verify production planning and traveler controls

Confirm customer requirement review records

Validate first-article inspection records

Audit nonconformance and CAR closure logs

Sign off internal audit readiness

Open corrective action for unresolved findings

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Production Line Quality Control Checklist

Raw Material Inspection

Verify supplier C of C and lot traceability

Check material against PO and drawing spec

Inspect for damage, corrosion, and shelf life

Run PMI on alloy-critical stock

Sample per ANSI Z1.4 AQL plan

Open an incoming NCR and segregate the lot

Setup and First-Article Inspection

Confirm work order rev and released drawings

Verify tooling and gauge calibration status

Run setup per the setup sheet

Perform FAI per AS9102 or internal inspection sheet

Correct the setup before release-to-run

In-Process Monitoring

Log hourly piece count and downtime reasons

Sample in-process per the SPC plan

Update the X-bar R chart and check rules

Audit operator adherence to work instructions

Final Inspection and Packaging

Perform final inspection per AQL sampling plan

Verify packaging, labels, and lot codes

Capture finished-goods photos for the batch record

Sign off the batch quality record

Non-Conformance and Closeout

Segregate non-conforming parts to the MRB cage

Open the NCR with MRB disposition

Close the work order with actuals in ERP

Brief the next shift at handover

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Quality Assurance Checklist

Shop Floor Conditions

Verify temperature and humidity logs

Open environmental excursion ticket

Walk the cell for 5S compliance

Confirm lighting and noise meet OSHA 1910.95

Incoming Material Verification

Match lot and heat numbers to the COC

Run PMI on alloy material

Sample per ANSI Z1.4 plan

Verify shelf life on time-sensitive material

Equipment and Tooling Readiness

Check gauge calibration stickers

Confirm PM is current on critical machines

Verify LOTO points and machine guarding

First-Article and In-Process Inspection

Run first-article inspection per AS9102

Pull in-process samples per the control plan

Update SPC control charts

Final Inspection and Disposition

Perform final inspection per AQL plan

Open NCR for rejected lot

Sign off the certificate of conformance

Records and Closeout

Attach traveler and inspection records to the WO

Confirm scrap and rework counts in the ERP

Brief next shift in the handover log

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Quarterly Industry Standards Compliance Review

Quality Management System Review

Pull the QMS document register

Run the internal ISO 9001 audit

Review open NCR and CAR aging

Verify critical-gauge calibration records

Capture management review meeting minutes

Environmental Compliance

Reconcile RCRA waste manifests against generator status

Inspect SPCC containment and spill kit stations

Confirm Tier II and TRI submissions are filed

Audit Title V air permit deviation logs

Walk the waste accumulation areas

Occupational Health and Safety

Confirm the OSHA 300A is posted

Verify LOTO procedures match the machine list

Audit forklift certifications by equipment type

Reconcile the SDS binder against chemical inventory

Run an evacuation drill

Supply Chain and Supplier Compliance

Review the AVL for expired qualifications

Pull supplier scorecards for OTD and PPM

Open a supplier CAR for the failing vendor

Verify CMRT responses for 3TG-bearing parts

Confirm PPAP packages for active customer programs

Data Security and Audit Closeout

Revoke access for terminated employees

Verify ITAR technical data segregation

Run a backup restore test

Open an IT incident and re-run the restore

Sign off on the quarterly compliance review

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Supplier Quality Audit Checklist

Pre-Audit Preparation

Confirm audit scope and applicable standard

Pull supplier history from the scorecard

Send the audit agenda and document request

Verify certifications are current and unsuspended

Quality Management System Review

Review the quality manual and policy deployment

Audit document and record control

Sample the internal audit program

Walk the CAR log for closure effectiveness

Process Control on the Floor

Verify control plans against actual process steps

Audit gauge calibration and MSA records

Review SPC charts at active work centers

Confirm setup approval and FAI discipline

Audit the engineering change control process

Product Quality and Traceability

Sample the incoming material inspection process

Trace a finished lot back to raw material

Review the NCR queue and segregation area

Audit final inspection and release records

Logistics and Sub-Tier Controls

Review on-time delivery and shipping records

Audit the approved sub-supplier list

Inspect packaging and labeling standards

Review business continuity and disruption plans

Closeout and Disposition

Hold the closing meeting with supplier leadership

Render the audit decision

Issue CARs for major findings

Schedule the follow-up surveillance audit

Update the AVL and supplier scorecard

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