PPT CAPA

Nonconformity, Corrective Action and Preventive Action ISO 9001:2008 Corrective Action says: The organization shall take action to eliminate the

cause of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered .

A documented procedure shall be established to define requirements for :

A) Reviewing nonconformities ( including customer complaints )

B) Determining the causes of nonconformitiesC) Evaluating the need for action to ensure D) Determining the implementing action needed E) Records of implementing action taken F) Reviewing corrective action taken

Nonconformity, Corrective Action and Preventive Action

ISO 9001:2008 Preventive Action says: The organization shall determine action to eliminate the

causes of the potential nonconformities in order to prevent their occurrence .

Preventive actions shall be appropriate to the effects of the

potential problems. A documented procedure shall be established to define

requirements for :A) Determining potential nonconformities and their causes B) Evaluating the need for action to prevent occurrence of

nonconformities C) Determining and implementing action takenD) Records of results of action taken E) Reviewing preventive action taken

Non Conformanity Is… The non-fulfillment of a specified ISO 9001:2008

requirement.

The departure or absence of one or more Product characteristics or Quality Management System elements from specified requirements.

The non-fulfillment of a specified QMS requirement.

Verifiable evidence that an element of the QMS is not documented or that the documented system is not being followed (evaluation of implementation).

Usually found and reported as part of an QMS Audit.

Results in a corrective or preventive action request


Definitions Corrective action – action to

eliminate cause of detected nonconformity

Preventive action – action to eliminate cause of potential nonconformity

Nonconformity, Corrective Action and Preventive Action Corrective action = reactive action taken

to avoid re-occurrence – Fixes immediate problem including mitigation of any environmental impact caused –Determine if problem possible in other locations

Preventive action = proactive action take to avoid occurrence – Addresses underlying cause (s) of non-conformances – May take longer to implement as may be dealing with longer-term solutions


Corrective action = reactive action taken to avoid re-occurrence –Fixes immediate problem including mitigation of any environmental impact caused–Determine if problem possible in other locations

Preventive action = proactive action take to avoid occurrence –Addresses underlying cause (s) of non-conformances–May take longer to implement as may be dealing with longer-term solutions


The Quality Management Representative (MR) is responsible for handling the investigation of any nonconformance to the QMS.

Section Managers are responsible for taking action to mitigate

any impacts and for initiating and completing corrective and preventive action.

All employees are responsible for bringing suspected

non-conformities to the attention of their supervisor or the MR.

Nonconformity, Corrective Action and Preventive Action C/PAR (Corrective/Preventive Action

Request) Date:

Impact/ Concern:(For additional information, use back and/or attach additional sheets)

Area/ Location: Name:______________________________

Section:____________________Phone: _____________________________

Return to:Your Supervisor or to: MR

MR Use Only: C/PAR Opened : Yes, Control # _________ No,

Resolution ______________________


Corrective Action Requests (CARs) are issued as a result of non-conformances identified during internal and external audits.

All CARs are handled and investigated the same way as C/PARs.

What are Correctiveand Preventive Actions?

Corrective action fixes the immediate problem (e.g., repair a leaking valve)

Preventive action is designed to stop the problem occurring again, or stop problems before they happen (e.g., improved maintenance procedures)

Effective preventive actions are a key to CONTINUAL IMPROVEMENT

Nonconformity, Corrective Action and Preventive Action Sources of Causes Deficiencies in communication Deficiencies in documentation Deficiencies in personnel training and

motivation Deficiencies in materials Deficiencies in tools and equipment Deficiencies in the operating

environment

Nonconformity, Corrective Action and Preventive Action Steps to Identify and Correct Non-

Conformance

Identify problem through routine inspection, monitoring, audit findings, trend analysis, employee comments, complaint, experience

Investigate problem and its underlying causes.

Involve persons with first-hand knowledge of the issues, and authority to achieve solutions

Identify best solution (s) and persons responsible for implementing them

Nonconformity, Corrective Action and Preventive Action Ensure solution is adequate for the size and

nature of the problem, i.e., fix the underlying cause (s) once and for all

Follow-up with monitoring to confirm that implemented solution

is effective long-term

Involve people throughout with sufficient influence to ‘make

things happen’ promptly

Nonconformity, Corrective Action and Preventive Action C/P Actions Paraphrased…

a) Identify, correct and mitigate problem

b) Determine cause (s) and take actions to prevent

recurrence (i.e. root cause)

c) Take any action needed to prevent problems d) Write down results of corrective and preventive

action (s) taken e) Review effectiveness of either corrective or

preventive action (s) taken

Non-ConformanceInvestigation Example PROBLEM: Monitoring results not submitted to

process on time Possible underlying causes: Responsibility for reporting not clearly

communicated Inadequate training or awareness of

reporting schedule requirements Written procedure not available Insufficient supervision and checking

Principles of Correctiveand Preventive Action Don’t ignore problems and hope

they’ll go away Ask: Who? What? When? How? Where?

WHY? until you arrive at the root cause of the problem

Fix deficiencies in the system, not just symptoms of the problem

Nonconformity, Corrective Action and Preventive Action One More Thing The organization shall implement and

record any changes in the documented procedures resulting from corrective and preventive action

This means that procedures must be kept up to date (i.e., maintained) to include new actions required to prevent previous problems

Nonconformity, Corrective Action and Preventive Action Consequences of Non-

Conformance MAJOR NON-CONFORMANCE Registration to ISO 9001 delayed until

problem is corrected and re-audited MINOR NON-CONFORMANCE Can receive registration to ISO 9001 but

must commit to fix problem within 30 days; correction will be confirmed on next audit

Nonconformity, Corrective Action and Preventive Action More Consequences of Non-

Conformance

QMS is an inter-dependent system; if one component is defective, the whole system is broken

One problem usually leads to another; pay now or pay much more later if first problem, and underlying causes, is not fixed quickly

Nonconformity, Corrective Action and Preventive Action Important points to remember are: Need open communication, without fear of

punishment for identifying a non-conformance

Need somebody with authority in charge of responding to non-conformances

Need thorough investigation of symptoms and

underlying causes of each non-conformance

involving knowledgeable persons and those affected by the non-conformance

Nonconformity, Corrective Action and Preventive Action Additional points to remember

are: Need identification and implementation of

lasting solutions that change the system (i.e., the way things are done), not just the symptoms

Need follow-up to ensure the solution provides lasting improvement

Need update documented procedures to include corrective and preventive actions

Nonconformity, Corrective Action and Preventive Action QUESTIONS


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PPT CAPA