Effective

Corrective Actions

Presented for:
Smithers Quality Assessments

Presented by:
John Sedlak

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 Corrective Action

Introduction

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 Introduction

• Objectives for this training:

– Hone our skills at executing reviews and
approvals of all required actions associated
with issued Corrective Action Reports…
• …regardless of where they originated.

– New perspective for Corrective Action thinking

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 Introduction
• Assumptions:
– You think of yourself as a quality professional
– You believe in the value of effective resolution
to any CAR issued
– You understand the basics of the corrective
action process
– You believe that corrective action investigation
and related actions are not the sole
responsibility of the quality manager

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 Introduction
• Evaluation of CAR-related actions
applies to CARs issued as a result of:
– SQA –identified nonconformances
– Client identified nonconformances (internal
audits, management review, significant
negative events or situations, supplier
issues)
– Customer complaints
– Regulatory issues

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 Introduction
• Difference between Corrective &
Preventive Action
– Corrective actions are reactive – something
has gone wrong and needs to be dealt with
in accordance with defined procedures
– Preventive actions are proactive – nothing
has gone wrong yet, so there is an
opportunity to see that things go as
planned
• Even “Corrective Actions” have an element of
prevention

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 Introduction

• Stuff Happens!!!
• Examples
– (QMS & EMS) Frequency of management
review is not maintained, two per year
required, only one executed in 2012; no
recommendations for improvement listed;
improvement of product not addressed;
conclusions about suitability, adequacy and
effectiveness not complete – missing
suitability and adequacy. (Based on
10/19/2012 meeting minutes.)

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 Introduction

• Examples (cont’d):
– (EMS) The report from Compliance
Consultants of America (the organization
that executes a compliance evaluation for
Acme Manufacturing) dated February 16,
2013 lists seven (7) noncompliance
issues, four (4) of which are repeat from
previous reports.

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 Introduction

• Examples (cont’d):
– (QMS) Documentation issues:
• Procedure P-XYZ is silent regarding control of
external documents
• Procedure P-ABC does not fully address the
requirements for prevention as defined by
clause 8.5.3.

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 Introduction

• Examples (cont’d):
– (QMS) Documentation issues (cont’d.)
• During the audit, examples of forms were found
with differing form numbers and dates:
– 1) Process Cutting; two form numbers – 100-2, rev 2,
3/20/2000 & 404-F rev 4, 3/20/2000
– 2) Competency Demonstration; two form numbers –
HR-F002-6.2.2, rev 2, 1/3/2009 & HR 6.2.2 F002,
1/3/2009, rev 2

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 Introduction

• Examples (cont’d):
– (QMS) Electronic scales used to measure
the amount of colorant added to resin are
checked for correct calibration on a
monthly basis, using a 2,000 gram weight;
tolerance for the actual scale +/- 5 grams
A review of three months of data indicated
that 52 of 78 initial readings were beyond
the +/- 5 grams tolerance with no evidence
of action taken to investigate the effect on
product.

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 Introduction

• All identified problems need to be

corrected.
• BUT – not all problems need to rise to a
level of importance where formal
corrective action is needed.

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 Introduction
• Two basic areas of thought when “stuff
happens:
– Correction: fix the identified problem
– Corrective action: fix the cause
– Yes, there are others, but we’ll expand on
those in coming slides.
– There is a tendency on many of our
clients to limit their actions to
Correction, or not do correction at all
(say it’s not applicable)

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 Introduction

• Correction:
– Limited to fixing the identified problem,
such as:
• Reworking (or perhaps scrapping) the product
• Correcting the typo
• Having the responsible person initial or sign the
affected document.
• Sending the missed COA.

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 Introduction

• Corrective action:
– In addition to fixing the problem, taking
steps to modify the system so the identified
problem does not recur, such as:
• Modifying a procedure to include additional
inspection points.
• Addition of a more reliable temperature
controller to the processing oven.

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 Introduction

• Toss-up question:

– Do all nonconformances require formal corrective

action?

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 Introduction
• From a client’s perspective, when should a
formal corrective action not be required?
– Condition is rare – never seen before, and cause
and solution are obvious to ensure it will not
recur
– Percent of product showing the problem is very
small and easily segregated, sorted-out, fixed,
etc. and is not a repeat problem
– Problem is system focused, but will not affect
product quality or delivery, e.g., a form is found
to be at the wrong revision level.

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 Introduction
• When should Corrective Action be
taken? Or, said another way, what
criteria should be used to decide when
“correction” will be sufficient or if
“corrective action” is needed?
– Cost
– Repeat problem - has occurred in the
recent past.
– Product is significantly out of specification.
– Condition may result in death or injury to
user.
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 Corrective Action

Corrective Action

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 Corrective Action
• The five (5) “C’s” of effective CAR
responses:
– Containment: Deal with the extent of the
problem
– Correction: Deal with the immediate
problem
– Cause determination: Determine the root
cause
– Corrective action: Implement action to
prevent recurrence of the problem
– Confirm: Is the problem eliminated? Any
new problems created?
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 Corrective Action
Problem Location

Parts, Documents, etc. Management System

Containment X

Correction X

Cause determination X

Corrective action X

Confirm actions X X

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 Corrective Action
• Containment: Deal with the extent of the
problem:
– Involves:
• Segregating product in organization’s position

• Evaluation of product in organization’s position

• Examination of other or similar product to see if the

problem exists elsewhere

• Looking at other documents or records of a similar nature

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 Corrective Action
• Containment: Deal with the extent of the
problem (cont’d.):
– Involves:
• Creating a temporary sort or other filter process to
protect the customer from receiving any more
defective product.

• Possible notification to customer that defective product

may exist at their facility

– May involve a recall of product already shipped

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 Corrective Action

• Containment : (cont’d.):
• Evidence of containment:
– Record of products, documents
reviewed/inspected
– Date range of inspection: how far back?
– Results of above inspection actions

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 Corrective Action

• Correction: Deal with the identified problem

– May involve:
• Rework (changing a document, form, etc.)
• Scrap
• Re-grading
• Sorting
– NOTE: applies to similar items found as part of
Containment (see previous slides)

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 Corrective Action

• Correction: (cont’d.)
• Evidence of correction:
– List of parts dealt with:
• How many repaired, reworked, scrapped?

– List of documents changed.

– Records of re-inspection activity.

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 Corrective Action

• Cause determination: Determine the

root cause
– Human error is rarely acceptable
– Key questions:
• What failed to allow the problem to occur?
• What failed such that our system did not detect
the problem until it was too late?

– Key consideration:
• Good definition of the real problem.

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 Corrective Action

• Cause determination: (cont’d.)

– When is “Human Error” an acceptable response?
• Questions to help:
– Are our procedures adequate?
– If followed, would problem not occur?
– Was person determined to be competent?
– Are our methods for determining competency
adequate?
– Is the person going through stressful personal
issues?

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 Corrective Action

• Cause determination: Determine the

root cause
– Methods:
• 5-Why? (SQA preferred method)
• Fish-bone analysis.
• Same? Different?
– Caution: there may be more that one issue, each
requiring its own, unique analysis

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 Corrective Action

• Cause determination: (cont’d.)

• Evidence of Cause determination:
– Copies of 5-Why analysis
– Copy of fish-bone analysis and related
conclusions
– Record of “Same-Different” analysis

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 Corrective Action

• Comment on “Root-Cause”
– Think of a “cause” as an on-off switch:
• If you turn off the cause, does the problem stay
fixed?
• If you turn on the cause, does the problem
recur?

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 Corrective Action
• Corrective action: Implement action to prevent
recurrence of the problem – such as:
– Retraining of personnel (correction) and
changing the current new employee training
process (corrective action)
– Moving from a hand-written log book to use
of an electronic recording process, one that
includes multiple prompts – all aimed at
preventing key information from not being
recorded
– Purchase and implementation of a new gage

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 Corrective Action
• Corrective action: Implement action to
prevent recurrence of the problem –
such as:
– Create a New Product (or Process)
checklist that includes:
• Environmental aspects & impacts
• Effect on inspection methods, e.g., gages,
calibration, responsibilities, etc.
• Review of current recording forms and methods
for adequacy.

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 Corrective Action
• Corrective action: (cont’d.)
• Evidence of corrective action:
– Copies of documents changed
(procedures, forms, checklists, etc.)
– List of attendees at training sessions.
– Copies of purchase orders for new gages,
equipment, etc.

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 Corrective Action
• Confirm: Is the problem eliminated?
Any new problems created? Involves:
– A reasonable time lapse between
implementation of the corrective action and
the confirmation, e.g., 30, 60 or 90 days.
– Auditing the situation to see if the actions
taken have truly prevented the problem and
have not caused new problems: interviews
and record reviews.
– Inclusion in future, routine audits

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 Corrective Action

• Confirm (cont’d.)
• Evidence of Confirm:
– Records showing date and results for audit
of changes to the system
– Statement that:
• Identified problem is eliminated
• No new problems identified

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 Corrective Action
• Typical problems seen with “accepted” corrective
action responses

– No real containment action taken (client marks

“n/a”)
– Correction limited to the identified problem
– The corrective action taken does not align with the
result of the cause analysis
– Management is too often “left off the hook”
– Corrective action is actually Correction
– Lack of evidence that client executed an effective
Confirm action

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 Corrective Action

Conclusion

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 Conclusion
• New Perspective:
– Think of every problem as a “profit leak”
– Believe that identification and elimination of
causes stops these “profit leaks”
– Do not be too quick to leap to conclusions
regarding causes
– Provide assurance that the real problem
has been identified and fixed; if not you are
wasting time and money.

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 Conclusion

• Open Discussion

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