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LAYERED AUDITS

QUALITY DEPARTMENT

Chris Psinas

February, 2010
Layered Audits

PURPOSE:
To provide a system to:
• verify compliance to the documented process
• instill discipline
• improve communication
• improve overall quality
SCOPE:
• Manufacturing Operations
• Shipping/Receiving
• Repair/Rework Area
• All Operations and other support functions

RESPONSIBILITY:
• Single Ownership
- Plant Manager
• Supported By
- Quality Manager
Strategic Plan - - P 2
Layered Audit Requirements

• Layered Audits shall be conducted for manufacturing 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.

• All Elements should be considered in developing the check list.

Strategic Plan - - P 3
Layered Audit Elements

(Example)

• Utilization of manufacturing assists (as applicable)


• Gages functioning and calibration confirmation
• Stacking / packing techniques
• Build / manufacturing techniques
• Visual aids presence and content
• Process parameter setting
• Job instructions
• Correct product identification
• Process steps adhered to
• Required inspections completed
• Torque monitoring (if applicable)
• Product dimensions or visual inspection
• Documentation / record completion
• Quality Gates (as applicable)
• Customer feedback
Strategic Plan - - P 4
Layered Audit Requirements cont’d

• 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, Prototyping and Post Mortem summaries.

Strategic Plan - - P 5
Layered Audit Requirements cont’d

• Customer or Erection Site used features shall be identified, listed


and checked in the manufacturing process with emphasis on:

• Key Characteristics
• Part Production Date Traceability
• Supplier pass through features
• Mounting (holes, taps, etc.)
• Mounting surfaces
• Electrical connections/connectors
• Clearances
• Others as identified by customer
Strategic Plan - - P 6
Layered Audit Requirements cont’d

• 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, or Plant


Manager shall verify (weekly) that supervisor
verification is being completed.

• Site leadership shall conduct layered audits at a


frequency defined locally.

Strategic Plan - - P 7
Layered Audits – Quality Elements

Example
REACTION (Special Cause) Prevention (Common Cause)

PFMEA
PLANT ISSUES RPN REDUCTION
TEAMS
External- NCR’s, etc
Cross Functional
Internal Blue Cards Shainin
AUDIT THE PROCESS
P.
8 STEP (8D) Corrective • Formal Line item document
Action F. CONTROL PLANS • Items Checked daily
• Is the system working?
• 12:15p.m. Report outs M. What’s critical to
• Fast Response the process?
E.
A. AUDIT % COMPLIANCE
JOB INSTRUCTIONS • Data Collection
• Participation
- Standardized Work • Responsiveness
• Integrity

RESULTS
• Quality Improved
Strategic Plan - - P 8 • Quality Stabilized
Layered Audit Matrix
Example SHIFT DAILY WEEKLY MONTHLY QUARTERLY

OPERATIONS MGR

COPRORATE MGR
Q.A. INSPECTOR

EXECUTIVE MGR
TEAM LEADER

SUPERVISOR

PLANT MGR
OPERATOR

PRESIDENT
Q.A. MGR

TBD
PART / PRODUCT
Error Proofing Verification
First Piece Inspection
Last Piece Inspection
Standard Work Instruction Present
Operator Training Tracking Sheet
Safety Issues
PROCESS
Set-up
SPC Com pliance
Tooling Approval (Sign-off)
Quality Gate Data
SYSTEM
Preventative Maintainance
Calibration
Lot Traceability
Housekeeping
VOICE OF THE CUSTOMER
6-Panel Posted
Action Plans Updated & on-tim e
PR/R's Posted
Custom er Delivery Perform ance
C.A.R.E.

Strategic Plan - - P 9
Layered Audit Results
PART NAME:
Example PART NUMBER: SHIFT:
CUSTOMER:
DEPARTMENT: WEEK ENDING:

Wednesday

Thursday

Saturday
Tuesday
Monday

Friday
Op A
Manufacturing

Are the operators using Insulation Tape that is less than 3 months
old per the specification.

Are the operators respecting the 50% overlap specification.

Are the parts manufactured and stored per First in First Out
(FIFO) requirements before next operation

Are Operators making their production count and no more.

Operations Total Non-Conforming Items

Total Non-Conforming Items

LIST ANY QUALITY OR MANUFACTURING CONCERNS ON ALL OPERATIONS.

Strategic Plan - - P 10
Layered Audit Results
Example

DEPARTMENT:____________ LAYERED AUDIT RESULTS

ITEMS NOT IN COMPLIANCE

ITEM NUMBER OF OCCURANCES

Strategic Plan - - P 11
Layered Audit Results
Example
DEPARTMENT:____________ LAYERED AUDIT RESULTS

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%
JAN FEB MAR APR MAY JUNE JUL AUG SEP OCT NOV DEC

JAN FEB MAR APR MAY JUNE JUL AUG SEP OCT NOV DEC
% IN COMPLIANCE:
# OF ITEMS ON ASSESSMENT:
# OF ASSESSMENTS
TOTAL # OF ITEMS ASSESSED:
# OF ITEMS IN COMPLIANCE:

Strategic Plan - - P 12
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