Manufacturing Process Assessment Checklist

• Site conducted

  Select

• Conducted on

  Date

• Prepared by

• Location
  Address

• Process

  Select

• 1.1Document Review: Verify Documents for compliance to IATF16949 requirement.<br> System revision list vs Shopfloor revisions verified.

  Yes

  No

  N/A

• 1.2 Previous Audit Findings: Review of previous findings to evaluate adherence and effectiveness of <br> closure.

  Good

  Fair

  Poor

  N/A

• 1.3 Corrective Action: Review of previous CPAR's to evaluate adherence and effectiveness of closure.

  Good

  Fair

  Poor

  N/A

• 1.4 Performance evaluations: Evaluate process performance to departmental objectives. <br> Evaluate trends and actual performance and if targets are not met, <br> evaluate action plans.

  Good

  Fair

  Poor

  N/A

• 1.5 Customer Specific Requirements: Review as per the Manufacturing QOS Model and CSR Matrix if CSR's <br> apply to the process and evaluate if these are considered in the<br> process design and application.

  Good

  Fair

  Poor

  N/A

• 1.6 Process design review: Comparison of FMEA, CP,Drawings and specification with special attention to <br> alignment of document and acceptable controls for SC's and CC's. <br> Verify process capability for all SC's and CC's vs controls.

  Good

  Fair

  Poor

  N/A

2. Assessment Criteria and Findings: Documentary requirements

• 2.1 Are documents legible, readily identifiable and controlled as applicable?

  Yes

  No

  N/A

• 2.2 Are records legible, readily identifiable and retrievable?

  Yes

  No

  N/A

• 2.3 Is there awareness of the Quality Policy?

  Yes

  No

  N/A

3. Assessment Criteria and Findings: Process Performance and efficiency

• 3.1 Are there measures of effectiveness/efficiency for this process?

  Yes

  No

  N/A

• 3.2 Are objectives, audit results, analysis of data, corrective and preventive actions used to continually <br> improve the effectiveness of the process?

  Yes

  No

  N/A

4. Assessment Criteria and Findings: Corrective & Preventative Action

• 4.1 Do the process metrics vs target indicate process effectiveness, e.g. scrap, rework, SPC/ Cpk/ Ppk, <br> customer (internal and external) and are complaints & warranty, arising from the process being <br> audited?

  Yes

  No

  N/A

• 4.2 In the event of performance metrics worse than the target, or unacceptable trends, are effective <br> corrective/improvement plans in progress?

  Yes

  No

  N/A

• 4.3 Are the layered audits conducted in accordance with departmental requirements? <br> Are corrective actions closed out timeously and effectively for layered and process audits?

  Yes

  No

  N/A

• 4.4 Are customer requirements met for the process as per the specified scorecard? <br> Are corrective actions related to process inefficiencies addressed?

  Yes

  No

  N/A

5. Assessment Criteria and Findings: Process design

• 5.1 Process Flow:<br> Are the operations carried out in line with the Work instructions and Process Flow Chart? (Process <br> Steps in sequence?)

  Yes

  No

  N/A

• 5.2 Work Instructions / Standardized work Instructions:<br> Is relevant, the latest release, Setup/ Work /Standard instruction readily available, displayed and legible?

  Yes

  No

  N/A

• 5.3 Are the Work instructions in line with the latest released Engineering Specifications?<br> Evaluate Product Specification depicted on Work Instructions against the Engineering Drawing.

  Yes

  No

  N/A

• 5.4 Do Work instructions, Control plans and PFMEA aligned with respect to Characteristic description, Class, <br> Specification, gauging frequency, gauging equipment, Controls & Reactions plans?

  Yes

  No

  N/A

• 5.5 Are the current process controls as shown in the Work instruction still valid?

  Yes

  No

  N/A

• 5.6 Reaction Plans:<br> Are the latest applicable "Reaction plans" available / displayed? <br> (Refer to Work instruction for applicable Reaction plans.)

  Yes

  No

  N/A

• 5.7 Is there evidence of RPN reduction activities on characteristics that are associated with high risk?<br> Explore Process departmental RPN reduction activities related to Core tool review.

  Yes

  No

  N/A

• 5.8 Are there any outstanding and past due dates for recommended actions of characteristics earmarked <br> for RPN reduction?

  Yes

  No

  N/A

6. Assessment Criteria and Findings: Human Resources

• 6.1 Is there awareness of everyone's responsibility for quality including the authority to stop production <br> and correct quality problems?

  Yes

  No

  N/A

• 6.2 Are personnel qualified relative to their specific tasks and are there records available (including contract <br> personnel)?

  Yes

  No

  N/A

• 6.3 How are personnel motivated and made aware of the importance of quality objectives or <br> responsibilities? <br> How are personnel motivated to make continual improvements and to create an environment to <br> promote innovation?

  Yes

  No

  N/A

• 6.4 Are the Skills matrix in line with the Skills, Competency, Versatility Matrix H-F-20, according to Procedure <br> H-PR-04?

  Yes

  No

  N/A

7. Assessment Criteria and Findings: Infrastructure, Maintenance and Work Environment

• 7.1 Are there any key process manufacturing equipment identified in the process? <br> Is there a critical spares list? <br> Is there stock of the spare parts?

  Yes

  No

  N/A

• 7.2 Is there a Preventative maintenance schedule available for maintenance equipment? <br> Are signed/closed schedules available and do they align with the schedule?

  Yes

  No

  N/A

• 7.3 Is there a tool/electronic gauge maintenance process? <br> Are tools and gauges checked in accordance with a schedule and no tool is overdue?

  Yes

  No

  N/A

• 7.4 Are product and employee safety addressed in manufacturing process activities?

  Yes

  No

  N/A

• 7.5 Is the work environment sufficient to achieve conformity to product requirements? <br> Are work areas clean, orderly and are safe working conditions maintained?

  Yes

  No

  N/A

8. Assessment Criteria and Findings: Setup verification (Poka Yokes included)

• 8.1 Are there records of Setup verification approvals, where specified for initial run (first offs), <br> changeovers, tool changes and shift changes?<br> In the event of out of specification conditions, do the records show containment and re-verification <br> of suspect items?

  Yes

  No

  N/A

• 8.2 Are the poka-yoke devices utilized and are there records of verification of the poka-yoke devices as per <br> the Work Instruction and Control Plan? <br> In the event of a poka-yoke device not functional or effective, do the records show containment and <br> re-verification of suspect items?

  Yes

  No

  N/A

9. Assessment Criteria and Findings: Control of non-conforming material

• 9.1 Are non-conforming and suspect items segregated, correctly identified and recorded according to <br> the Non-Conformance Procedure?

  Yes

  No

  N/A

• 9.2 Are all rework and scrap areas demarcated and all parts individually identified? <br> Are scrap and rework data analyzed?

  Yes

  No

  N/A

• 9.3 Are there escalation procedures/processes for scrap and reworks?

  Yes

  No

  N/A

• 9.4 Is there an independent re-approval process for all reworks?

  Yes

  No

  N/A

10. Assessment Criteria and Findings: Identification & Traceability

• 10.1 Are components, sub-assemblies and assemblies correctly packed and identified in the process?

  Yes

  No

  N/A

• 10.2 Are product traceable through the process and are records available?

  Yes

  No

  N/A

• 10.3 Is there a sequential flow of products (FIFO) to ensure the quality of products is not compromised?

  Yes

  No

  N/A

11. Assessment Criteria and Findings: Gauging requirements

• 11.1 Are the correct gauges/test equipment used according to the Work Instruction? <br> Are gauging/test equipment within its calibration period?

  Yes

  No

  N/A

• 11.2 Are gauge R&R's conducted in accordance with the required schedule and is there evidence of the last <br> MSA conducted on gauges?

  Yes

  No

  N/A

12. Assessment Criteria and Findings: Statistical Process Control

• 12.1Are SPC checks done where statistical control methods are required? <br> (Evaluate according to the Control Plan characteristics, type of chart, sample size/frequency)

  Yes

  No

  N/A

• 12.2 Are processes where SPC is applied in control and capable (Cpk /Ppk > 1.33)?

  Yes

  No

  N/A

• 12.3 If not in control and capable, are corrective & containment measures in place and does 100% <br> Inspection apply?

  Yes

  No

  N/A

13. Audit Feedback report and meeting completed

• 13.1 Were all audit findings communicated with process owners before CPAR's was issued. <br> Audit closing meeting (signed H-F-18) <br> PDF of Audit report in System

  Yes

  No

  N/A

Doc Req

• Yes

  No

  N/A