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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