Layered Audit
Layered Audit
Page 1
Audit the area and verify as many of the checklist items as possible.
Page 2
The checklist should be developed using input from a cross-functional team. Checklists must include the following minimum requirements: Review error-proofing verification records Review FTQ tracking, reporting, and reaction Verify that the operator is following standardized work Verify that the operator is trained/certified. Other items should be included in the checklist based on Quality system or Customer Satisfaction issues. Examples include: Rework or repair instructions available and being followed Gages calibrated Preventive maintenance complete Material properly identified Proper process settings Layered_audit Revised: October An example checklist is included in this 7, 2009 procedure as Appendix A.
Correct all non-conforming items within area of responsibility. Note the corrective action taken and date on the checklist.
Provide a brief description of the nonconformance on the checklist. Items not audited should be noted as Not Reviewed. Corrections should be made and put in place immediately
Relay all other unsatisfactory items to the responsible personnel and note who was contacted on the checklist
If unsatisfactory items have the potential to place the product quality at risk, immediate action must be taken by manufacturing to correct the situation. Issues that cannot be corrected immediately should be tracked throughout the plant corrective action process or through the internal audit process and escalated as required. Communicate non-conformances to Manufacturing Engineering for feedback into FMEAs if appropriate.
Layered audit results will be reviewed by management on a periodic basis. The effectiveness of the layered audit process will be evaluated by tracking/reviewing layered audit schedule adherence and first time conformance results (number of items conforming during the audit vs number of items checked see example Appendix C). Repeat issues should be identified and addressed.
Page 3
Corrective Action/Comments
Date Corrected
Set-Up
Are Visual Aids (required by the Control Plan) available? Are Change Over instructions followed?
Control Plan
Are control plan checks made at the proper frequency, with the correct sample size and on the correct form? Are product/process checks within specification? If not, are reaction plans being followed? Are significant process events recorded? Are alarm limits being used? Is a reaction plan available and being followed?
Measurement Systems
Are Error Proofing devices, gages and fixtures verified? Are all gages (required by the Control Plan) available at the workstation? Are the gages numbered, calibrated and match the Control Plan? Is containment information documented when the product is nonconforming? Is rework/teardown completed per instructions with proper identification? Are Preventive Maintenance activities complete to schedule?
Containment/Rework
P.M. Activities
Page 4
35
Tue
40
Wed
45
Thur Mon
50
Fri Tue Thu
55
Mon Wed
Tue
320 250
Jan 76%
Feb 83%
Mar 86%
Apr 90%
Page 5