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Writing Clear and Concise

Non-conformances (NCs)
Presented By

Larry Henderson
BSI Americas, Inc

Mike Gallagher
Lockheed 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 DONT 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 audits
aerospace oversight and other feedback, NC writing has been
identified as one of the more significant 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 organization
after the audit was completed; and not understandable at later
date.
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
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 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 NCs.
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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 or
interacting 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
CHECK ACT
Activities
Controls
Documentation
Resources
Objectives
Deploy &
conform
with plan
Measure &
monitor for
conformity &
effectiveness
Analyze/review
Decide/change
Improve
effectiveness
Continual
Improvement
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 the
process.
Be unambiguous and concise.
Not be a restatement of the audit evidence.
Record the requirement against which the NC
was detected.
If possible, write out the exact text of the
requirement.
The audit evidence must support the audit
finding.
The evidence must be specific to the
violated requirement.
Evidence must be traceable to the NC.


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Examples of POOR NC Statements
Example: Two pieces of calibrated equipment was past
due calibration.

(THIS GIVES ONLY A BRIEF INDICATION OF THE
PROBLEM)


AND ALSO
The statement does not give the auditee any indication
that there is a system/process failure.
It appears as a single instance.
It does not identify the actual requirement being
offended-actually, it incorrectly states the requirement.
As written, the auditee could easily assume the NC was a
single incident and take action ONLY related 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 as
generic as possible to help direct the
auditee to the systems issue instead
of the specific incident.
Keep the specific details in the
objective evidence area, if at all possible.
The NC statement should include
enough details so that the auditee can
respond to exactly what the auditor
found.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 not
performed would be detrimental to the integrity
of the product.)
Non-conformance states:
No preventative action records exist. (This
would equate to an absence of a quality
management system element.)

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

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Writing of NC Statements
Non-conformance: (Clearly define and document the
systemic failure within the non-conformance. You
want ensure the client understands the exact nature
of the non-conformance. Too many words could mis-
lead the client.)
The system for the control of the process for product
design failed to ensure authorization or approval was
given prior to proceeding from Stage 2 to Stage 3 of
the product design.
Objective Evidence: (Quote appropriate aerospace
standard clause, work instruction, procedure or
process requirement)
The Design/Engineering review record did not
indicate authorization was given to proceed to Stage
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 auditees 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 clients 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 locked
room where all non-conforming material is stored
until the material is dispositioned.
-During Johns review of the room he notices that
material dispositioned as scrap is placed in large
metal containers and the containers are then also
stored in the locked room. When John asks what
happens with the containers, he is told that the
local scrap dealer takes them away.
Should John:
Show that The Great Widget Company is
conforming?
Ask to see the customer approval of the current
scrap 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 Review
procedure. It states they have defined measurable
objectives for productivity, Customer satisfaction, and
quality. When you ask to see the measures looked at
during a management review meeting, the Plant Manager
hands you a 3 inch pile of papers. As you go through the
information, you notice there are plenty of charts, graphs,
and pivot tables. Seems like this place measures
everything they possible can, but there are no goals listed
or explanations for trends going in the wrong direction.
The Plant Manager understands each chart and is clearly
involved, but when asked how he uses them to drive
improvement, 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 its QMS.
The plants 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 Hector Aircraft
Components, you note that the purchasing procedure, HAC 123,
does not address positive recall per AS9100 section 7.4.3 paragraph
two, and the companys process does not address periodically
validating test reports for raw material in accordance with section
7.4.3 paragraph three.
The QM, Hector, immediately corrects the master purchasing
procedure and saves the revised form in the companys electronic
media. He demonstrates that the master purchasing document,
HAC Admin Form 01 now shows the requirement to validate test
reports, and that the 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 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 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

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????Questions????