Professional Documents
Culture Documents
DATE:
AUDITOR:
SUPPLIER CONTACT:
CONTACT EMAIL:
EMAIL:
This audit corresponds to the current Quality Systems Basics requirements as defined in the QSB presentation
revised in March, 2009. This audit applies to all suppliers regardless of which revision of the QSB presentation was
used for training. The new presentation contains several new requirements which are included in this audit. This
audit supersedes any previous audit and presentation revisions. If a QSB audit was conducted using the audit form
approved for use at that time and prior to this revision date, it is should not be necessary to repeat the entire audit
unless it has been longer than 2 years.
AUDIT SUMMARY
KEY STRATEGIES
1.0
FAST RESPONSE
2.0
CONTROL OF
NONCONFORMING PRODUCT
3.0
VERIFICATION STATIONS
4.0
STANDARDIZED OPERATIONS
5.0
OPERATOR TRAINING
6.0
ERROR PROOFING
VERIFICATION
7.0
8.0
RISK REDUCTION
9.0
CONTAMINATION CONTROL
POTENTIAL
SCORE
AUDIT
SCORE
TOTAL SCORE
AUDIT STATUS
STATUS
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
Note: YELLOW and RED status on any question requires corrective actions.
Follow-up may be done on site or via E-mail; at the auditor's discretion.
Application of this audit's requirements, including requirements added after
December 31, 2008, and the results to the supplier's status is at Supplier Quality's discretion.
STATUS FOR INDIVIDUAL QUESTIONS
R
R
R
Y
G
Rev 20090213
1.1
1.2
1.3
SCORE
R/Y/G
NR
NR
NR
Is there a defined process for Problem Solving leading to root cause identification and elimination?
1.4
NR
Is there a system in place to capture information that supports continuous improvements to all operations/processes?
A system to capture and institutionalize
lessons learned.
1.5
1.6
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NR
NR
Rev 20090213
EVIDENCE REQUIRED
Leadership reviews Lessons Learned
process to assure implementation.
LOOK FOR
COMMENTS
SCORE
NR
SCORE / POTENTIAL
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R/Y/G
Rev 20090213
2.1
2.2
2.3
R/Y/G
NR
BEST PRACTICE:
System is Stoplight visual management where red indicates scrap
or and yellow indicates suspect product/material. Green or any
other color (except yellow or red) indicates acceptable product.
NR
NR
Is there a nonconformance quality alert and notification procedure that meets customer requirements?
2.4
2.5
2.6
2.7
NR
NR
Scrap is prevented from unintended use, 1) Procedure and method for materials/parts designated as scrap to
tracked and reduced through on-going
ensure it is properly identified and kept from being reintroduced
continuous improvement.
back into the normal material flow. (e.g. destruction, paint, locked
container)
2) Performance metrics and goals established to reduce scrap at all
levels of the operation.
Leadership involvement in internal and
external spill, containment and
communication activities
NR
NR
SCORE / POTENTIAL
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SCORE
3.1
R/Y/G
NR
BEST PRACTICE:
- Look for a minimum of 1 at the end of each product assembly
line, or between departments such as molding, paint, assembly,
which provides feedback to upstream operations.
3.2
1)
2)
3)
4)
5)
3.3
3.4
3.5
1)
2)
3)
4)
NR
NR
NR
NR
SCORE / POTENTIAL
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4.1
4.2
COMMENTS
SCORE
R/Y/G
NR
NR
4.3
4.4
4.5
NR
6 of 12
NR
NR
Rev 20090213
EVIDENCE REQUIRED
LOOK FOR
COMMENTS
SCORE
R/Y/G
OPERATOR INSTRUCTIONS
Is there a systematic approach to develop Operator Instructions for all work.
Procedure, instructions or other
documentation that requires
development of operator instructions for
all work.
4.6
NR
4.7
NR
4.8
1)
2)
3)
4)
5)
6)
NR
SCORE / POTENTIAL
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5.1
SCORE
R/Y/G
NR
5.2
NR
5.3
1) Individual Job training record with dates and trainer signoff for each
job.
2) Record indicates the steps in training & skill/knowledge level
achieved for each job:
3) Follow-up includes the trainer audits employee to standard work
instructions, verifies quality & productivity within shift and again
approximately one day later.
NR
BEST PRACTICE:
- Chart showing cross training/certification level in a cell such as a
flexibility chart.
- Look for a job rotation plan or log. How often does team rotate?
- The number of Team Members certified per station should
support the Job Rotation Plan.
- If it does not, look for a plan such as a Flexibility Chart 2x2 or 4x4
matrix, that shows the status, actual vs planned number certified
per station that is being used to maintain job rotation.
5.4
5.5
NR
NR
SCORE / POTENTIAL
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6.1
6.2
6.3
NR
Error Proofing device locations shall be 1) Master list of all devices that prevent/detect the manufacture or
documented.
assembly of nonconforming product.
Management periodically reviews results 1) Verification failures on Fast Response Tracking Sheets, Layered
of verification.
Audit, Management Review agenda, Verification tracking forms
available.
NR
NR
SCORE / POTENTIAL
7.0 LAYERED PROCESS AUDITS
Is there a system in place to verify the documented manufacturing/assembly process through layered audits?
7.1
7.2
Written Procedure
Audit & work instructions
Counter measure process
Owned by Manufacturing
7.3
NR
All levels of the organization participate 1) Audit Schedule showing level of participation and frequency.
in Layered Process Audits at established 2) Evidence that ALL layers of the organization perform regularly
frequencies.
scheduled standardized audits. Plant Manager should be monthly,
Shift Leaders and Management Support Staff - Weekly, Group
Leader-Team Leaders-Daily.
3) Tracking to ensure every work station is evaluated on regular basis.
Audit Check sheet includes:
Workstation, Quality (Customer Focus),
and System high risk items.
7.4
1)
2)
3)
4)
NR
NR
NR
7.5
7.6
7.7
NR
NR
NR
SCORE / POTENTIAL
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Rev 20090213
EVIDENCE REQUIRED
LOOK FOR
COMMENTS
SCORE
R/Y/G
8.1
1) PFMEA available for all part numbers and all operations, especially
high risk such as labeling and rework.
2) Accurate Severity/Occurrence/Detection Ratings with Valid RPN
numbers and revision dates with some correlation to known
problems (PRRs, etc).
3) Are updated on a regular basis (living documents).
8.2
8.3
1)
2)
3)
4)
8.4
8.5
8.6
NR
NR
NR
NR
NR
NR
SCORE / POTENTIAL
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Rev 20090213
9.1
9.2
SCORE
1) Procedure to include:
- Methods defining sediment collection
- System to measure to a standard
- Application using statistical method to monitor and control
2) Site leadership review of results for compliance and continuous
improvement
9.3
NR
1) Method to prevent extra parts or materials that may fall into or stick
to products which are not intended as part of the finished product.
such as:
Magnetic tools, Shielding, Fixture Orientation, Rollovers and
Dump Stations, Magnetic wrench.
2) Methods are verified through error proof verification and/or Layered
Process Audits.
NR
9.5
9.6
R/Y/G
NR
9.4
COMMENTS
NR
1) Procedure to include:
- Methods to measure retained material (i.e. Tunk test)
- Verification that measurements are taken and results are
documented.
- Any non-conformance to standards are documented and
corrective actions are implemented.
- Processes/Equipment are verified through error proof
verification, preventative/predictive maintenance, and Layered
Process Audits.
2) Site leadership review of results for compliance and continuous
improvement
NR
NR
SCORE / POTENTIAL
10.1
10.2
10.3
NR
NR
NR
SCORE / POTENTIAL
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11.1
SCORE
NR
NR
11.2
11.3
COMMENTS
11.4
R/Y/G
NR
NR
SCORE / POTENTIAL
SCORING CRITERIA
0
No implementation: Corrective Action Required
1
Written implementation plan: Corrective Action Required
2
In place, not followed: Corrective Action Required
YELLOW: Requirement partially implemented
3
4
GREEN: Requirement met
NR
NR: Not Reviewed
Note: Enter appropriate score based on R Y G score criteria and hit enter. Correct color will appear in R/Y/G cell.
Not Reviewed is used when:
1) Immediate focus does not include the strategy. Give future review date in comments box.
2) Plan to review in the future. Give future review date in comments box.
3) Question or strategy does not apply to this supplier. Explain in comments box.
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Rev 20090213