Breakout_-_NCR_writing_and_closure.pdf

8/20/2019 Breakout_-_NCR_writing_and_closure.pdf

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Writing Clear and Concise

Non-conformances (NCs)

Presented By

Larry Henderson

BSI Americas, Inc

Mike GallagherLockheed Martin Space Systems

Company


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RMC

Aerospace Auditor Workshop

AGENDA

• Writing Non-conformances (NC)

Analysis.

• Parts of a Non Conformance.• Making it clear.

• What is the Process Approach?

• Accepting NC Responses.


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Non-conformance Report Writing

AND THE CLIENT SAYS:

• I DON’T HAVE A CLUE WHAT YOU ARE

SAYING OR WHAT YOU ARE TALKING ABOUT……???

OR PRIME INDUSTRY OVERSIGHT

AUDITOR

• WHY IS THIS AN NC?

• WHAT REQUIREMENT IS VIOLATED?


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NC Writing Analysis

From analysis of data collected from witness audits, office auditsaerospace oversight and other feedback, NC writing has beenidentified as one of the more significant concerns.

Identified weaknesses were:

• The NC as written was “incident specific” and did not addressthe systematic issue (s).

• The NC as written could not be understood by the organizationafter the audit was completed; and not understandable at laterdate.

• The NC did not identify the actual requirement being offended.

• The NC did not identify the supporting objective evidence.

• Poor CA and root cause analysis accepted by the auditor.

• No indication corrective actions were verified at NC closure.

NOTE: POORLY WRITTEN NCs SUPPORTS “SOFTGRADING” CUSTOMER, OEM, AND IAQG AND AAQGCONCERNS.


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Writing Process

Non-conformances

• NCs must be clearly written.

• Should address the process/system which is

deficient.

• Objective evidence gathered should identify

which process is deficient.

• What is the process?

– You must understand the process to verify

conformance or non-conformance.

• Is the non-conformance identified, systemic to

the process?


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Process Approach

The process approach emphasizes theimportance of:

• Understanding and meeting requirements.

• Looking at processes in terms of added value.

• Obtaining results of process performance.

• Continual improvement of processes via the

documenting of NCs.


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Process Approach

The process app roach systematically

identifies and manages the linkage,

combination, and interaction of a system of

processes within an organization

AS9100 is based on a process approach

to quality management

A process is a set of interrelated orinteracting activities that uses resources

to transform inputs into outputs


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Process Approach

Input Output

Resources Product

Monitoring & Measurement Opportunities(Before, During, and After the Process)

Process Approach

PROCESS(set of interrelated orinteracting activities)

PROCEDURE(Specified way to carry out an activityor process – may be documented or

not)


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YourProcess

Process Approach

PLAN DO

CHECKACT

• Activities

• Controls

• Documentation

• Resources

• Objectives

• Deploy &conformwith plan

• Measure &monitor forconformity &

effectiveness

• Analyze/review

• Decide/change

• Improve

effectiveness

ContinualImprovement

The Plan - Do - Check - Act (PDCA) methodo logy

appl ies to al l processes


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Process Audit Scope

•Specific to the function, area,requirement, system or process being

audited.

•Processes audited should remainconstant.

•Follow audit trails to the end to obtain

good objective evidence.

•Document objective evidence to support

NC identified.


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HOW DEEP SHOULD YOU

GO!----INTO THE PROCESS

•Evaluate the process thoroughly.

•Avoid “tunnel vision”.

•Ensure objective evidence supports conformance

or non-conformance of the process.

•Gather enough objective evidence to support

your final decision.

•Adequate “sampling” of objective evidence.

– Repeatability of objective evidence which

indicates the process is not working.

– indication of consistent process failure.


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Three Distinct Parts of An NC

An audit NC should have three distinct parts:

• A clear statement of the non-conformance.

• The requirement, or specific reference to the

requirement.

– If you cannot identify a requirement, then

you cannot raise a non-conformance.

• And finally, objective evidence that supports the

statement of non-conformance; based on the

requirement.


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Statement of the NC

• Should be self-explanatory and related to theprocess.

• Be unambiguous and concise.

• Not be a restatement of the audit evidence.

• Record the requirement against which the NCwas detected. – If possible, write out the exact text of the

requirement.

• The audit evidence must support the auditfinding.

– The evidence must be specific to theviolated requirement.

– Evidence must be traceable to the NC.


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Examples of POOR NC Statements

• Example: Two pieces of calibrated equipment was pastdue calibration.

(THIS GIVES ONLY A BRIEF INDICATION OF THEPROBLEM)

AND ALSO

• The statement does not give the auditee any indicationthat there is a system/process failure.

• It appears as a single instance.

• It does not identify the actual requirement beingoffended-actually, it incorrectly states the requirement.

• As written, the auditee could easily assume the NC was asingle incident and take action ONLY related to the twopieces of calibrated equipment.


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Making it Clear

• Changing the structure and the way the NC iswritten can assist in getting the auditee to

address the “root cause” of why the calibrated

equipment is past due calibration.

• The NC must highlight the issue that there is asystem/process failure vs a single incident

failure.

• Thus, the corrective action and root cause

should be focused towards system/processfailure, not the observed incident.


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NC Statement “TIPS”

TIPS:• The statement of NC should be as

generic as possible to help direct theauditee to the system’s issue… instead

of the specific incident.• Keep the “specific details” in the

objective evidence area, if at all possible.

• The NC statement should includeenough details so that the auditee canrespond to exactly what the auditorfound…….even years later.


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Examples of Poorly Written NCs

Non-conformance states:• A required block torque test was not being

performed. (Classified as “Minor” yet a test notperformed would be detrimental to the integrityof the product.)

Non-conformance states:

• No preventative action records exist. (Thiswould equate to an absence of a qualitymanagement system element.)

Neither NC statement tells the client what wentwrong...what process is broken?


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Writing of NC Statements

• Non-confo rmance: (Clear ly def ine and doc ument thesystemic fai lure wi th in the non -confo rmance. Youwant ensu re the cl ient understands the exact natureof the non-conformance. Too many words could mis- lead the c lient.)

– The system for the control of the process for product

design failed to ensure authorization or approval wasgiven prior to proceeding from Stage 2 to Stage 3 ofthe product design.

• Object ive Evidence: (Quote appropriate aerospacestandard clause, work instruction, procedure orprocess requirement)

– The Design/Engineering review record did notindicate authorization was given to proceed to Stage3 of the product design.


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Writing of NC Statements

• Stated Requirement: (What objectiveevidence is/was used to indicate a non-

conformance existed? What record,

document, procedure was used to verify

existence of a non-conformance) – AS9100, Clause 7.3.4c, at suitable stages,

systematic reviews of design and

development shall be performed in

accordance with planned arrangement;authorization is required for progression to

the next design stage.


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Accepting Closure of CAR

Responses

The auditee’s corrective action response shouldcover three areas, as a minimum:

• Containment of the current situation and

identified systemic failure.

– Action to control or mitigate a problem; couldincludes correction, corrective action.

• Root cause analysis as to why the system

failed.

• Finally, a systemic corrective action to preventa recurrence of a failure in the system/process

(could be preventive action may apply here.)


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Corrective Action

Acceptance/Closure

• Does CA response address systemprocess NC?

• Is Root Cause adequate?

• You must know and understand theprocess to accept the CA and root

cause.

• Does client’s response ensure no re-

occurrence?


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Scenario One

-Auditor John Hancock is reviewing control of non-conforming material at The Great Widget Company.The Great Widget Company has a separate lockedroom where all non-conforming material is storeduntil the material is dispositioned.

-During John’s review of the room he notices that

material dispositioned as scrap is placed in largemetal containers and the containers are then alsostored in the locked room. When John asks whathappens with the containers, he is told that thelocal scrap dealer takes them away.

Should John:

• Show that The Great Widget Company isconforming?

• Ask to see the customer approval of the currentscrap procedure?

• Write an NC?


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Scenario One

The Correct answer is C: Write an NC.

• John should write an NC because

AS9100 Section 8.3 requires that scrapmaterial be segregated until physically

rendered unusable.

• Currently The Great Widget Company

segregates their scrap but when it leavestheir facility it has not been rendered

unusable.


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Scenario Two

• During an audit, you read the Management Reviewprocedure. It states they have defined measurableobjectives for productivity, Customer satisfaction, andquality. When you ask to see the measures looked atduring a management review meeting, the Plant Manager

hands you a 3 inch pile of papers. As you go through theinformation, you notice there are plenty of charts, graphs,and pivot tables. Seems like this place measureseverything they possible can, but there are no goals listedor explanations for trends going in the wrong direction.

• The Plant Manager understands each chart and is clearlyinvolved, but when asked how he uses them to driveimprovement, or how he knows if he is meeting his goals,he has no answer.


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Scenario Two

You Should:A. Do nothing, the thoroughness of the

management review is evidence that it is

acceptable. Improvement, although

desirable, is not required.B. Write an NCR because there has been no

improvement and therefore the management

review is ineffective.

C. Write an NCR, as there is no evidence ofdefined measurable quality objectives as

stated in the procedure.


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Scenario Two

The Correct answer is C: Write an NC.

• AS9100 Section 5.6.1 states, in part

“that top management shall includeassessing opportunities for improvement

of its effectiveness of it’s QMS.”

• The plant’s procedure stated they will

have defined measurable objectives forquality and none were found during this

review.


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Scenario Three

While auditing the purchasing department of Hector AircraftComponents, you note that the purchasing procedure, HAC 123,does not address positive recall per AS9100 section 7.4.3 paragraphtwo, and the company’s process does not address periodicallyvalidating test reports for raw material in accordance with section7.4.3 paragraph three.

The QM, Hector, immediately corrects the master purchasingprocedure and saves the revised form in the company’s electronicmedia. He demonstrates that the master purchasing document,HAC Admin Form 01 now shows the requirement to validate testreports, and that the procedure shows the positive recallrequirement.

You should:

A. Write an NC and accept it on siteB. Write an NC and leave it open

C. Do not write an NC because the issue has been resolved

D. Follow up to see if the company actually uses the new procedure


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Scenario Three

You should:

A. Write an NC and accept it on site

B. Write an NC and leave it open

C. Do not write an NC because the issuehas been resolved

D. Follow up to see if the company

actually uses the new procedure


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Scenario Three

The Correct answer is B: Write an NC.

• When a major component of the quality

system is missing, it requires an NC.• Base on severity of NC, some NCs

cannot be closed on site

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Breakout_-_NCR_writing_and_closure.pdf

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