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QSB Audit 022205
QSB Audit 022205
This audit corresponds to the current Quality Systems Basics requirements as defined
in the QSB presentation dated 11/24/04. This audit applies to all suppliers regardless of
which revision of the QSB presentation was used for training. This audit supercedes
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 not
necessary to repeat the audit.
AUDIT SUMMARY
POTENTIAL AUDIT
KEY STRATEGIES STATUS IS CORRECTIVE ACTION REQUIRED
SCORE SCORE
16 16 G
FAST RESPONSE
CONTROL OF NON- 24 24 G
CONFORMING MATERIAL
12 12 G
STANDARDIZED WORK
STANDARD OPERATOR 20 20 G
TRAINING
24 24 G
RISK (RPN) REDUCTION
ERROR PROOFING 12 12 G
VERIFICATION
28 28 G
LAYERED AUDITS
12 12 G
C.A.R.E.
12 12 G
LESSONS LEARNED
TOTAL SCORE: 160 160
Audit status is equal to
AUDIT STATUS the lowest color status of G
theabove strategies.
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 results to the supplier's status is at the SQE's discretion.
Owner report out includes tracking form, Problem solving form (5S, 8D)
problem solving form, PFMEA, Control Plan, referenced, Control Plans, PFMEA.
workforce notification, etc.. Follow an issue from Fast Response
Tracking Form through the exit criteria. 4 G
Fast Response issues are linked to Layered Layered audit and C.A.R.E. checklists,
Audits, C.A.R.E., Lessons Learned, Standardized Work Instructions,
Standardized Work Instructions, etc... Lessons Learned contain past or 4 G
present Fast Response issues.
SCORE / POTENTIAL 16 16
CONTROL OF NONCONFORMING PRODUCT
Is there a system in place to ensure A consistent tagging system is used to identify Color coding of scrap containers, hold
products that do not conform to suspect and nonconforming product. Preferred tags, scrap labels, in-process tags,
specified requirements are prevented system is Stoplight visual management where travelers, routers, etc… If red tags are
from unintended use? red indicates scrap or rejected material and used for both scrap and suspect
yellow indicates suspect material. Green or any material, tag must have disposition. 4 G
other color (except yellow or red) indicates Suspect tags should have last
acceptable product. operation performed.
Nonconforming and suspect material are Segregation areas are identified and/or
segregated. foot printed: scrap bins, rework tables,
hold areas, etc… 4 G
SCORE / POTENTIAL 24 24
STANDARDIZED WORK
Is there a system in place to develop Standardized Work Instructions are posted at Review instructions; must include work
standardized work instruction all operations where there are human elements, operator work path, and
(methods and sequence) for all operators. operation cycle time. 4 G
operations?
All affected operators are trained in the use of Operator Training records or equivalent
Standardized Work Instructions posted at each operation. 4 G
SCORE / POTENTIAL 12 12
STANDARD OPERATOR TRAINING
Is there a system in place to define Operator training records document specific Revisions and dates of completed
the minimum content and tracking for areas of training such as safety, quality record forms for operators working in
all operators new to an operation keeping, gaging, etc…? manufacturing area. Procedure for 4 G
and/or for operators in need of storage and easy retrieval of records.
refresher training?
Trainers verify quality at a frequency to assure Training record, audit checklist,
all standards are met . Trainer or equivalent operator Quality documentation. New
audit employee within shift and again operators following Standardized Work
approximately one day later. Trainers verify Instructions. 4 G
Standardized Work Instructions are being
followed.
Downstream operations are notified of new New operator tags, labels, stamps or
operators? equivalent to show product affected by 4 G
an operator in training.
Training records for supplemental employees Documentation, scheduling, and
document refresher training within the last three tracking forms for operator refresher 4 G
months. training.
Records reflecting training status of all Operator Tracking Sheets or
operators posted at each operation. equivalent posted at all operations. All
operators listed including supplemental
employees. Review training dates and 4 G
tracking sheet revision dates.
SCORE / POTENTIAL 20 20
Proactive approach to reduction of highest RPN Top RPN list, tracking charts and multi-
values has been implemented. Top RPN list disciplinary team minutes noting
with action plans. improvement actions and completion 4 G
details.
RPN reduction tracking charts updated and Management review minutes and
reviewed by management. posting of tracking charts. 4 G
Has a multi-disciplinary team Identification and tracking of past Quality Multi-disciplinary team meeting notes,
identified and analyzed (Pareto Chart, failures with a top 5 list and action plans. action plans and past quality failures
etc...) past Quality failures (both top 5 list..
external and internal)? 4 G
Occurrence and Detection ratings for past Updated Detection ratings on PFMEA.
failures accurate and reflect past corrective Note revision date of PFMEA
actions and/or error proofing.. documentation to address error 4 G
proofing and verification of past
failures.
SCORE / POTENTIAL 24 24
ERROR PROOFING VERIFICATION
Is there a system in place to verify Procedure requiring documentation of Master list of all devices that
that error proofing/ detection devices verification for error proofing/detection devices. prevent/detect the manufacture or
used in manufacturing and assembly assembly of nonconforming product.
are functioning properly? Documentation of device verification at 4 G
a minimum of once per day.
SCORE / POTENTIAL 12 12
LAYERED AUDITS
Is there a system in place to verify the Checklist of high risk items (customer used Completed audits at a frequency of
documented manufacturing/assembly features) audited a minimum of once per shift? once per shift performed by operator or
process through layered audits? inspector. 4 G
System to document results and communicate Layered Audit tracking forms, posted
to management. audit results, management review 4 G
notes or meeting agenda.
Addition of Layered Audit issues to the Lessons Completed Lessons Learned forms
Learned system. that reflect layered audit results,
nonconformances and lessons 4 G
learned.
SCORE / POTENTIAL 28 28
C.A.R.E.
Is there a system to designate and Procedure implemented to require 100% Audit list of customer satisfaction
100% inspect customer satisfaction inspection of identified customer satisfaction items, especially pass through items. If
items? items. When 100% is not feasible, an alternatives to 100% inspection are
alternative method of increased inspection is utilized, documentation to support 4 G
utilized. Procedure includes review of warranty when and what method is used as well
returns, past problems, high RPNs, pass- as duration.
though items and PRR's.
Procedure requires immediate reaction to Audit form requires corrective action.
failures. System to report failures to
management (Fast Response and 4 G
Layered Audits).
Leadership reviews C.A.R.E. results. Form or meeting minutes that
demonstrate leadership's review
process. 4 G
SCORE / POTENTIAL 12 12
LESSONS LEARNED
SCORE / POTENTIAL 12 12
0 No implementation: Corrective Action Required
1 Written implementation plan: Corrective Action Required
2 In place, not followed: Corrective Action Required
YELLOW: requirement partially
3 Note: Enter appropriate score based on R Y G score criteria and hit enter. Correct color will appear in R/Y/G cell.
implemented
4 GREEN: requirement met