Layered Audit Process

1. PURPOSE:

The purpose of this procedure is to define the process for performing and documenting
layered audits. The purpose of performing layered audits is to a) verify compliance to
the documented manufacturing/assembly process to assure the production system is
working optimally, b) involve various levels of management in the audit process, c)
remove roadblocks to correcting potential issues which are identified by the audit and d)
lead to standardized work practices.

2. DEFINITIONS:

Layered Audit: An audit that is performed by various levels (layers) of management

to assure conformance to Quality system requirements.

Error Proofing Verification – Checking operation of devices that prevent the

manufacture or assembly of non-conforming product. For the purposes of this
procedure, devices which detect and stop the transfer of non-conforming product,
e.g. 100% in-line inspection equipment) is included. If possible, proper functioning
of the error-proofing device should be verified during the layered audit. The intent is
to ensure error proofing devices with the potential to fail, wear, misalign, mis-locate
or otherwise become out-of-adjustment, be switched off, disabled, bypassed or
removed, are verified and or mastered. The minimum requirement during the
management layered audit is to check the verification log sheet (because error-
proofing verification is often performed by a different person than the manufacturing
system or process control audit. Layered audits should ensure that error-proofing
verification frequency is adhered to, and that alternate inspection is in place if error
proofing is not functioning properly.

3. RESPONSIBILITIES:

3.1 It is the responsibility of the Director of Operations (Manufacturing) (or supplier

leadership equivalent) to ensure that resources exist to carry out the requirements. It is
recommended that plant Quality personnel provide on the job training as required to
personnel who will be conducting these audits (i.e. walk the process using the audit
checklist as a guide).
3.2 It is the responsibility of the Plant Manager (or supplier leadership equivalent) to
ensure that the audits are conducted.

4. PROCESS

In general, this process is designed to allow for various levels of plant leadership to
assess adherence to procedures, work instructions, control plans, etc. and correct non-
conformances on a real time basis. Layered audits may also be conducted to verify
compliance to other specific Customer/regulatory requirements (eg. PFMEA audits,

When printed, this document is uncontrolled unless properly identified as controlled. Revised 8/26/08
 Layered Audit Process
control plan audits, production part approval compliance audits, and preventive
maintenance audits).

Various layers of management shall conduct the Layered Audit. (All job functions may
not apply at every supplier, so the process should be executed by the applicable
equivalent job function. Supplier’s designated Delphi Supplier Quality Engineer can
provide guidance on acceptable process execution methodology)

Operations Supervisor – The Operations Supervisor shall audit a specific process

operation, line, or cell once per shift.

Middle Management – Middle management (eg. General Supervisor) will select at

random and audit one line, cell, or department at a minimum of once per week. Middle
management will also assure that checklists are being completed by the operations
supervisor and that open issues are closed.

The Plant Manager and/or Plant Manager’s Staff will audit one line, cell, or department
at a minimum of once per month. Plant Manager will also assure that checklists are
being completed by the middle management and open items are being closed.

Process Flow Diagram for Layered Audits

Schedule audit An audit schedule must be developed to

track progress of layered audit cycle
completion. See Appendix B for example
of audit schedule. Select an area that has
not been audited recently based on the
audit schedule.
The checklist should be developed using input
from a cross-functional team. Checklists must
include the following minimum requirements:
Obtain or develop a layered audit  Review error-proofing verification
checklist 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
An
When printed, this document is uncontrolled unless properly example
identified checklist is included
as controlled. in this
Revised 8/26/08
procedure as Appendix A.
 Layered Audit Process

Audit the area and verify as many Review documentation, observe activities,
of the checklist items as possible. and interview manufacturing personnel
(without impacting production).

Document results as satisfactory or Provide a brief description of the non-

unsatisfactory conformance on the checklist. Items not
audited should be noted as “Not
Reviewed”.

Correct all non-conforming items Corrections should be made and put in

within area of responsibility. Note place immediately
the corrective action taken and date
on the checklist.

Relay all other unsatisfactory items If unsatisfactory items have the potential to
to the responsible personnel and place the product quality at risk, immediate
note who was contacted on the action must be taken by manufacturing to
checklist 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.

Monitor and report layered audit Layered audit results will be reviewed by
results 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.

When printed, this document is uncontrolled unless properly identified as controlled. Revised 8/26/08
 Layered Audit Process
APPENDIX A – LAYERED AUDIT CHECKLIST EXAMPLE
Process Element Y Corrective Action/Comments
N Date
Corrected
Communication
 Are employees aware of any recent Formal Customer
Complaints (FCC’s) / quality issues?
Workplace Organization & Environment
 Is in-process & outgoing material properly identified
 Is traceability in place where required?
 Is FIFO used?
 Is nonconforming or suspect product identified and placed
in a designated area?
 Are proper containers used in production, including
outgoing material?
 Is workplace clean and orderly?
Set-Up
 Are Visual Aids (required by the Control Plan) available?
 Are Change Over instructions followed?
Operator Certification/Standardized Work
 Are Operators following standardized work?
 Are Operators certified on the job?
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?
First Time Quality
 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?
Containment/Rework
 Is containment information documented when the product
is nonconforming?
 Is rework/teardown completed per instructions with proper
identification?
P.M. Activities
 Are Preventive Maintenance activities complete to
schedule?

When printed, this document is uncontrolled unless properly identified as controlled. Revised 8/26/08
 Layered Audit Process
APPENDIX B – AUDIT SCHEDULE EXAMPLE

Managemen Audit Dept 30 35 40 45 50 55

t Category Frequency
Supervisor 1 Once/shift Mon Tue Wed Thur Fri Mon

Supervisor 2 Once/shift Mon Tue Wed

General 1/week Thu

Supervisor
Plant 1/month Tue
Manager/Staff

APPENDIX C – LAYERED AUDIT FIRST TIME CONFORMANCE TRACKING

EXAMPLE

400 350
350 320
300
300 250
250
Items Audited
200
150 First Time Conforming
100
50
0
Jan 76% Feb 83% Mar 86% Apr 90%

When printed, this document is uncontrolled unless properly identified as controlled. Revised 8/26/08