Writing Clear and Concise

Non-conformances (NCs)

Aerospace Auditor Workshop

Quality System Department

Oziel Cardenas Vargas

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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……???

WHY IS THIS AN NON CONFORMANCE?

WHAT REQUIREMENT IS VIOLATED?

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NC Writing Analysis

From analysis of data collected from witness audits,office audits aerospace oversight and other feedback,NC writing has been identified as one of the moresignificant concerns.

Identified weaknesses were: The NC as written was “incident specific” and did not address

the 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 “SOFT GRADING” CUSTOMER, OEM, AND IAQG AND AAQG

CONCERNS.

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Writing Process

Non-conformances

• NC’s 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 the

importance 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 NC’s.

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Process Approach

The process approach 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 or

interacting 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 activity or process – may be documented or

not)

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Your Process

Process Approach

PLAN DO

CHECKACT

• Activities

• Controls

• Documentation

• Resources

• Objectives

• Deploy & conform with plan

• Measure & monitor for conformity & effectiveness

• Analyze/review

• Decide/change

• Improve

effectiveness

ContinualImprovement

The Plan-Do-Check-Act (PDCA) methodology applies to all processes

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Process Audit Scope

Specific to the function, area,

requirement, system or process being

audited.

Processes audited should remain

constant.

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 theNC was detected.

– If possible, write out the exact text of therequirement.

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 calibratedequipment was past due calibration.

“THIS GIVES ONLY A BRIEF INDICATION OF THEPROBLEM”

AND ALSO

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

• It appears as a single instance.

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

• As written, the auditee could easily assume theNC was a single incident and take action ONLYrelated to the two pieces of calibrated equipment.

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Making it Clear

Changing the structure and the way the

NC is written 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 a system/process failure vs. a

single incident failure.

Thus, the corrective action and root

cause should be focused towards

system/process failure, not the observed

incident.

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NC Statement “TIPS”

TIPS:

The statement of NC should be asgeneric as possible to help direct theauditee to the system’s issue… instead ofthe specific incident.

Keep the “specific details” in the objectiveevidence area, if at all possible.

The NC statement should include enoughdetails so that the auditee can respond toexactly what the auditor found…….evenyears later.

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Examples of Poorly Written NCs

Non-conformance states:

A required block torque test was not beingperformed. (Classified as “Minor” yet a testnot performed would be detrimental to theintegrity of 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 whatwent wrong...what process is broken?

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Writing of NC Statements

Non-conformance: (Clearly define anddocument the systemic failure within the non-conformance. You want ensure the clientunderstands the exact nature of the non-conformance. Too many words could mis-lead the client.)

– The system for the control of the process forproduct design failed to ensure authorizationor approval was given prior to proceedingfrom Stage 2 to Stage 3 of the product design.

Objective Evidence: (Quote appropriateaerospace standard clause, work instruction,procedure or process requirement)

– The Design/Engineering review record did notindicate authorization was given to proceed toStage 3 of the product design.

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Writing of NC Statements

Stated Requirement: (What objective

evidence 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 should

cover three areas, as a minimum:

Containment of the current situation and

identified systemic failure.

– Action to control or mitigate a problem;

could includes correction, corrective action.

Root cause analysis as to why the system

failed.

Finally, a systemic corrective action to

prevent a 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 system

process NC?

• Is Root Cause adequate?

• You must know and understand the

process 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 WidgetCompany. The Great Widget Company has aseparate locked room where all non-conformingmaterial is stored until the material isdispositioned.

-During John’s review of the room he notices thatmaterial 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 scrap material be

segregated until physically rendered

unusable.

• Currently The Great Widget Company

segregates their scrap but when it leaves

their 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 Managerhands 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

of defined 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 include

assessing opportunities for improvement

of its effectiveness of it’s QMS.”

• The plant’s procedure stated they will

have defined measurable objectives for

quality and none were found during this

review.

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Scenario Three

While auditing the purchasing department of HectorAircraft Components, you note that the purchasingprocedure, HAC 123, does not address positive recallper AS9100 section 7.4.3 paragraph two, and thecompany’s process does not address periodicallyvalidating test reports for raw material in accordancewith section 7.4.3 paragraph three.

The QM, Hector, immediately corrects the masterpurchasing procedure and saves the revised form in thecompany’s electronic media. He demonstrates that themaster purchasing document, HAC Admin Form 01 nowshows the requirement to validate test reports, and thatthe procedure shows the positive recall requirement.

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 issue has been resolved

D. Follow up to see if the company actually uses the newprocedure

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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 issue

has 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