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8/13/2019 Common TS16949 Audit Findings - Perry Johnson
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Perry Johnson
Registrars, Inc.
Breakfast Club #2
Common Nonconformities and
Pitfalls During a TS 16949 Audit
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Todays Agenda
Logistics
Review of common nonconformities during
TS 16949 audits
Stage 1 audits Stage 2, surveillance and recertification
audits
Overview of disciplined problem solving Questions & Answers
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Logistics
Restrooms are out the double glass doors
Mens room is the first right
Ladies room is the second right
Evacuation plan is posted near the elevator. Please help yourself to food.
Presentation is meant to be an informal,
open dialogue. Questions/feedback arewelcome!
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Common Stage 1
Nonconformities
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Common Stage 1
Nonconformities
Stage 1
TS 16949 Stage 1 audits are very
black/white. You are either 100%
ready, or youre not ready. One stage 1 criterion not met will
result in a decision of not ready to
proceed.
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Common Stage 1
Nonconformities From Rules 3rd Edition, section 6.5, the
following are reviewed during the Stage 1audit: Evidence of one full cycle of internal audits
to ISO/TS 16949 followed by a managementreview,
List of qualified internal auditors and thecriteria for qualification,
List of automotive customers and theircustomer-specific requirements if applicable,
Customer complaint summary andresponses, scorecards and special status
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Common Stage 1
Nonconformities Most common Stage 1 nonconformity is poor process
definitions. A process IS a set of activities that transform inputs
into outputs.
A process IS NOT a procedure.
A process IS NOT the sections of the standard. The second most common Stage 1 nonconformity
relates to the 12 months of process performance data:
Indicators are not measurable
Do not have 12 months of data
Interaction of processes in the quality manual does notinclude interactions with remote supporting functions.
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Why are these
inappropriate?
Inappropriate measures of processes
Improve customer satisfaction
Strive to continually improve all
processes Improve delivery performance
Reduce employee turnover Lower PPM
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Common Stage 1
Nonconformities
Internal audit is not a full cycle.
Management review misses some of the
hidden inputs outside of section 5.6.2 and
5.6.3
Monitoring of quality objectives
Review of cost of poor quality
Analysis of actual and potential field failures Measurements at specified stages of design
and development
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Common Stage 1
Nonconformities
No or poor qualification criteria for
internal auditors
Organization cannot effectively
access customer scorecards in realtime.
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Common Nonconformities
4.2.3 Control of documents
Evidenced by: An organizations
failure to have their arms around all
customer-specific requirements or thelatest revision of customer-specific
requirements.
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Common Nonconformities
5.5.3 Internal communication:
Evidenced by: employees not knowing
relevant quality objectives or
customer/quality issues.
6.2.2 Competence, training and awareness
Evidenced by: Competency requirements
not being defined.
Training records and competency records
are different; a file with a bunch of training
certificates may not be conforming,
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Common Nonconformities 7.4.1 Purchasing process
Evidenced by: No records of supplierevaluation or re-evaluation. No records ofresults of any necessary actions arising from
the evaluation. 7.4.1.2 Supplier quality management
system development
Evidenced by: No accredited certificate on-file for a supplier.
Unaccredited certificate on-file for a supplier.
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Common Nonconformities 7.5.1.1 Control plan
Evidenced by: A failure to review and update thecontrol plan when any change occurs affectingproduct, manufacturing process, measurement,logistics, supply sources or FMEA.
7.5.1.4 Preventive and predictive maintenance Evidenced by: Program doesnt include availability of
replacement parts for key manufacturing equipmentor objectives for the maintenance program.
Evidenced by: No predictive maintenance methods.
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Common Nonconformities 7.5.5.1 Storage and inventory
Evidenced by: Failure to maintain an
inventory management system, such as
FIFO.
7.6 Control of monitoring and measuring
equipment
Evidenced by: Failure to assess and record
the validity of previous measuring results
when equipment is found nonconforming.
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Common Nonconformities
7.6.1 Measurement system analysis
Evidenced by: Not conductingstatistical studies to analyze thevariation present in the measuringequipment system or not selecting theappropriate study.
7.6.3.1 Internal laboratory Evidenced by: Failure to have a
defined laboratory scope.
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Common Nonconformities
8.1.2 Knowledge of basic statistical concepts
Basic statistical concepts not being understood at theoperator level.
8.2.2 Internal audit
Evidenced by: Auditors auditing their own work.
8.2.2.4 Internal audit plans Evidenced by: Elemental based, as opposed to
process based, audits.
Audit plan is static; frequency does not increase wheninternal/external nonconformities or customercomplaints occur.
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Common Nonconformities
8.2.2.5 Internal auditor qualification
Evidenced by: Auditors not meetingcustomer-specific qualification requirements.
8.5.2 Corrective action
Evidenced by: Poor corrective actionresponses on internal nonconformities.
8.5.3 Preventive action
Evidence by: Lack of a preventive actionprocess.
Notice I did not say lack of preventive actions!
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So, what do we do
about thesenonconformities?
Disciplined Problem Solving
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It all starts with
a well written
nonconformity/finding.
A nonconformity/finding should have
three distinct parts: Statement of Nonconformity
Objective Evidence Citation of the Requirement not
Fulfilled
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Statement of Nonconformity
Often the nonconformity recorded is not the
problem, but a symptom of the problem.
The problem must be expressed as an issue
with the system.
If the problem is expressed in terms of a
person or incident, it is at the symptom
stage.
Both internal and third party auditors makethis mistake.
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Statement of Nonconformity
It is important to get to the true
problem, i.e. the system issue, or the
problem-solving efforts will not be
effective. Fixing symptoms will not stop the
issue from recurring.
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Statement of Nonconformity
Betterfinding:
Nonconformity: The system for recording
employee training and competence is not
completely effective.
Objective Evidence: There was no trainingmatrix for the first shift operator running job
#9954 indicating competence to run that job.
Requirement: ISO 9001:2008, 6.2.2e
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Actions Taken to Correct
Also called corrections or containment
actions
These are actions taken with respect to the
symptom or incident.
Incident Specific Actions
Containment actions or corrections are
important. Should be taken immediately to stop the
symptom
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Actions Taken to Correct
These actions typically take two forms:
We calibrated the gage, or We controlledthe form.
We added inspection to catch any further
occurrence. Inspection adds cost to the system, not
value
Later we will learn that once correctiveaction is implemented, then costly addedinspections can be removed from thesystem.
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Actions Taken to Correct
Containment actions or corrections should
be very specific: The training matrix for the first shift operator
running job #9954 was updated to reflect his
competency to run the job unsupervised. The most common pitfall with containment
actions or corrections is failure to include anextent analysis.
Please see the handout, ANAB Heads Up#137.
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Root Cause Analysis
Many CARs restate the incident for
the Root Cause Analysis This is not acceptable.
Our organization failed to update thetraining matrix for the operator running job#9954.
Some CARs give Containment
Actions for the Root Cause Analysis This is also not acceptable.
WAKE UP! THIS IS THE
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WAKE UP! THIS IS THE
MOST IMPORTANT SLIDE!A good root cause analysis answers
this question:
What in the system failed such
that the problem occurred?
The focus is on the system, not the
incident.
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Root Cause Analysis
Some problems may have multiple
root causes.
Some problems may have severalpossible root causes.
If the root cause cannot bediscovered, all require corrective
action.
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Root Cause Analysis
If the root cause has been found, the
problem can be turned on andturned off.
Like a light switch If the problem cannot be turned on
and off at will, then the root cause has
probably not been found.
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They Why Technique
Nonconformity: The system for recording
employee training and competence is notcompletely effective. Objective Evidence: There was no training
matrix for the first shift operator running job
#9954 indicating competence to run that job. 1st Why: The first shift Supervisor failed to update
the training matrix as required by the first of themonth.
2nd
Why: Before the end of the previous month,the Human Resources Manager would e-mail thetraining matrix template to all of the departmentSupervisors, but this didnt happen this particulartime.
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The Why Technique
3rd Why: The HR Manager left the
company before the end of the month,and her replacement didnt e-mail the
template to all Supervisors.
4th Why: The Procedure for Training(QP18-01) didnt include a requirement to
prompt the new HR Manager to e-mail the
template to all Supervisors.
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Root Cause Analysis
PJR will not accept the following for root
cause: Oversight
We misunderstood the requirement.
I forgot. Another ISO 9001 blunder
Our consultant messed up.
Human error Your organization should not accept these
either!
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Corrective Action
Not only addresses the system, but should
be irreversible Should involve a change in the system
Training by itself is generally not a systemchange.
Incident specific actions orcorrections/containment actions are notirreversible
In the automotive industry, corrective actionsshould prompt changes to the DFMEA,PFMEA and Control Plan
May require a new PPAP
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Corrective Action
There should be at least one
corrective action for each root causethat was identified.
Subsequent data should show that the
problem has 100% disappeared.
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Corrective Action
Nonconformity: The system for recording employeetraining and competence is not completely effective.
Corrective Action: Section 4.6 of the Procedure forTraining (QP18-01) was updated to include arequirement for the HR Manager to e-mail the training
matrix template to all Supervisors for updating beforethe end of each month. The new HR Manager wastrained on this added requirement. She also added anautomatic reminder to MS Outlook to perform this task.
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Verification
This is a critical and often not
performed step in the problem solvingprocess.
Many CAR forms do not have places
for verification at the appropriate
locations.
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Verification
The following should be verified:
Containment Actions/Corrections have beentaken.
Proper Root Cause Analysis has been
performed (turn off - turn on). Irreversible Systemic Corrective Actions
have been implemented.
Containment Actions/Corrections have beenremoved, where appropriate.
Preventive Actions have been taken, ifappropriate.
V ifi i
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Verification
Understand that corrective actions are
reversible. System changes mean how work is
performed changes.
Change is difficult.
Systems tend to return to where people are
comfortable.
Continue to verify actions even after you
get positive results on the first verification.
A k l d t
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Acknowledgments
Partial slide content provided by the
International Automotive OversightBoard (IAOB)
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Thank you!
Questions/Comments/
Complaints/Gripes?