1. LAYERED AUDITS

2. - verify compliance to the documented process - instill discipline
LAYERED AUDITS
PURPOSE:
To provide a system to:
- verify compliance to the documented process
- instill discipline
- improve communication
- improve overall quality
SCOPE:
Assembly Area
Manufacturing Operations
Shipping/Receiving
Repair/Rework Area
All Operations and other support functions
RESPONSIBILITY:
Single Ownership
- Plant Manager
Supported By
- Quality Manager

3. REQUIREMENTS:
Layered Audits shall be conducted for manufacturing and
assembly of high risk items at a minimum of once per shift.
Frequency of Layered Audits based on production volume or level of risk
associated with process.
Layered Audits supplement ongoing control plan and job instruction
checks.
A check list of high risk items to be verified during Layered Audits
shall be established.
Elements should be considered in developing the check list. (Example)

4. (Example)
Elements

5. REQUIREMENTS (continued):
Layered Audits results shall be recorded.
Non-conformities shall be addressed immediately
Reaction plan(s) for non-conformities detected during Layered
Audits shall be documented and available for use.
Corrective actions shall be documented.
Results shall be summarized and reviewed by the
manufacturing site leadership.
Layered Audit documentation shall be compiled in the
Lessons Learned (key strategy) database.

6. REQUIREMENTS (continued):
Customer used features shall be identified, listed and checked in
the manufacturing process with emphasis on:
- Supplier pass through features
- Mounting (holes, taps, etc.)
- Electrical connections/connectors
- Mounting surfaces
- Clearances
- Missing/wrong brackets
- Incorrect parts
- Others as identified by customer

7. REQUIREMENTS (continued):
The following is an example of a Layered Audit with three levels
of management involved in the process:
- The manufacturing supervisor shall verify (daily) all quality
documentation is completed by operators.
- The manufacturing area manager shall verify (weekly) that
supervisor verification is being completed.
- Site leadership shall conduct layered audits at a
frequency defined locally.

8. QUALITY ELEMENT: LAYERED AUDIT
Example
GMPT model
REACTION (Special Cause
Prevention (Common Cause)
PFMEA
RPN REDUCTION
CUSTOMER CONCERNS
External- PRR’s, etc
Internal
TEAMS
Cross Functional
Shainin
AUDIT THE PROCESS
8 STEP Corrective
Action P. F. M. E. A.
Formal Line item document
-Items Checked daily
- Is the system working?
CONTROL PLANS
-12:15p.m. Report outs
-Fast Response
What’s critical to
the process?
AUDIT % COMPLIANCE
JOB INSTRUCTIONS
-Data Collection
-Participation
-Responsiveness
-Integrity
-Standardized Work
RESULTS
-Quality Improved
-Quality Stabilized

9. LAYERED AUDIT MATRIX (Example)

10. (Example)

11. (Example)

12. (Example)

13. (Example)