common ts16949 audit findings - perry johnson

8/13/2019 Common TS16949 Audit Findings - Perry Johnson

1/48

Perry Johnson

Registrars, Inc.

Breakfast Club #2

Common Nonconformities and

Pitfalls During a TS 16949 Audit


2/48

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


3/48

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!


4/48

Common Stage 1

Nonconformities


5/48

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.


6/48


7/48

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


8/48

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.


9/48

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


10/48

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


11/48

Common Stage 1

Nonconformities

No or poor qualification criteria for

internal auditors

Organization cannot effectively

access customer scorecards in realtime.


12/48


13/48

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.


14/48


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,


15/48


16/48

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.


17/48

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.


18/48

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.


19/48


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.


20/48


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.


21/48


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!


22/48

So, what do we do

about thesenonconformities?

Disciplined Problem Solving


23/48

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


24/48

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.


25/48


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.


26/48


27/48


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


28/48


29/48

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


30/48


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.


31/48


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.


32/48

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


33/48

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.


34/48

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.


35/48

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.


36/48


37/48

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.


38/48

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.


39/48

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!


40/48


41/48

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


42/48

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.


43/48

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.


44/48

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.


45/48

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


46/48

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


47/48

Acknowledgments

Partial slide content provided by the

International Automotive OversightBoard (IAOB)


48/48

Thank you!

Questions/Comments/

Complaints/Gripes?

common ts16949 audit findings - perry johnson

Documents