PRANEET SURTIQuality Consultant

Lead Auditor ISO 9001:2015 B.E Mechanical

by

“A man learns from his mistakes” CAPA helps us to simplify the above !

CAPA process is a structured, formalized way to investigate NC and determine appropriate corrections, corrective actions and preventative actions and measure their effectiveness. (With records)

A mature CAPA system can serve as a useful tool for analyzing past events, correcting existing non conformities and preventing future events.

A mature CAPA system goes beyond regulatory compliance to positively impact our customers by increasing the value of our products and services.

 ISO 9001:2008 : Clause 8.5.2“The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.” ISO 9001:2015 : Clause 10.2 Nonconformity and corrective action

Clause 10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall:a) react to the nonconformity and, as applicable: [Correction]b) take action to control and correct it;c) deal with the consequences;[Nonconformity can be anything deviating from the standard requirements]b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur [Corrective Action] or occur [Preventive Action] elsewhere, by:a)  reviewing and analyzing the nonconformity; [Description of NC]b) determining the causes of the nonconformity; [RCA of NC]c) determining if similar non conformities exist, or could potentially occur; [Platforms at Risk]d)  implement any action needed; [Correction]e) review the effectiveness of any corrective action taken; [Effectiveness Measure]f) update risks and opportunities determined during planning, if necessary; [Update Risk Documented Information]g) Make changes to the quality management system, if necessary. [Update Changes in the Documented Information]h) Corrective actions shall be appropriate to the effects of the nonconformities encountered. [Effectiveness Measure]

Clause 10.2.2 The organization shall retain documented information as evidence of:a) the nature of the nonconformities and any subsequent actions taken;b) the results of any corrective action.

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Complaint Handling Nonconforming (Unexpected, unwanted events with a

Quality System) Product Supplier Performance Accidents Equipment Monitoring Process Controls Cost Reduction Effort Audits Suggestions Continuous Improvement Effort

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State the problem in measurable terms how often, how much, when, and where

Emphasize the effects (risk) safety, death, injury, rework, cost, etc.

Avoid words that are broad and do not describe the

conditions or behavior such as careless, neglect, oversight.

Do not use abbreviations of words, acronyms. Do not state solution in issue statement. Do not state root cause in issue statement.

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A root cause is the reason for a condition or an action at its origin or source.

In the context of problem solving, a root cause is one considered to be far enough into the sequence of causes and effects, that removing it will eliminate the effect completely and permanently.

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Define method of investigation of root cause

Include quality tools used▪ Is/Is Not, ▪ Cause and Effect, ▪ 5 Why’s, etc.

Document Dates of investigation Data reviewed (data

sources, records, dates) Corrections or

Containment measures Results: Statement of

Cause

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Is / Is Not Diagram

WHAT

WHEN

WHERE

EXTENT

IS IS NOT

EFFECT

PEOPLE MATERIAL

METHODS MEASUREMENT

MACHINE

ENVIRONMENT

Cause

Why

Is Is Not

WhatWhat object has the problem?

What is the defect?

What similar object could have the problem but does not?

What defect could the object have but does not?

WhereWhere is the object located geographically when the defect is noticed?

Where is the defect located on the object?

Where could the object be located but it is not?

Where could the defect be located but it is not?

When

When was the defective object first noticed? When has it been observed since?

What is the timing pattern (continuous, random, or cyclical) and trend?

When could the defective object been noticed, but was not?

What could the timing pattern and trend be but is not?

ExtentHow many objects have the defect?

How extensive is the defect?

How many objects could have the defect but do not?How extensive could the defect be but is not?

E.g. Problem - Flat Tire

Why? Nails on garage floorWhy? Box of nails on shelf split

openWhy? Box got wetWhy? Rain thru hole in garage

roofWhy? Roof shingles are missing

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Used to structure data collection and analysis to find the root cause of a problem.

Methods

EnvironmentMaterials

ManMachines

Problem definition and analysis

Analysis Tool : Cause & Effect Diagram

Effect

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Effect

Cause (Machine) Use for grouping ideas. Any grouping that make sense can be used. The most common are:

Methods, Machines, Materials, People and Environment

The Problem

1st why?

2nd why?

3rd why? 4th why?

5th why?

Cause (Method)

The problem statement is the difference between what isis and what should beshould be Focus on

Facts finding, not fault finding ! whatwhat is wrong, not whywhy it’s wrong

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Implement a solution to address the cause not the symptom

Lists corrective and preventive actions (if applicable) Clearly addresses root causes Commensurate with the risk of the issue Identification of task owners and task due dates Implementation due date CAPA Monitoring Keep records

Implementing a verified solutionTesting during formation of action

planValidateTracking (where, how many, who)Keep records

CAPA is useful if and only when the implemented action plan is effective, so before freezing the CAPA the effectiveness of the implemented plan is measured.

Monitor performance indicators and compare “before” and “after” by assigning a particular time frame

Achieve specific targets - achieving a pre-determined PPM level

Statistical Data Analysis-Performance must lie within a set of statistically derived control limits

Emphasis should primarily be on identifying the most effective fix

Recurring issues Resources ($$$) are spent on

“handling” failure rather than learning from it and preventing “more of the same”

Field issues

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What to do when a effectiveness check fails, and what are the consequences?

Close the CAPA and open a new one? Get an extension? Leave the CAPA open and investigate

why?

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Investigate CauseRe-assess Risk

Proposed Solution

Verify/Validate

Implement

EffectivenessCheck

NO

YES

Data Sourceindicates

problem stillexists.

DetermineAdditional

Action

NO

Action Plan Complete

?

?

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Was the Problem

Statement well defined?

Effectiveness Checks

CAPA will be closed after measuring the effectiveness set at the particular value.

The effectiveness of CAPA with be discussed with all personnel in team meetings organized monthly.

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Reduction in quality issuesA reduction in the severity of issuesBetter designed products/processes Improved customer satisfactionBetter business results

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“Your mistakes can be your Stepping Stones for Success if appropriate actions are taken at proper time”

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PRANEET SURTIManagement Auditor l Quality Consultant[ Lead Auditor ISO 9001:2015, B.E Mechanical Engineering ]

ANM Strategic & Management Consultants Pvt. Ltd. Raipur, Chhattisgarh IND

Cell : +91 8109773774 (Personal), +91 7024154549 (Official) Gmail: praneetsurti20@gmail.com LinkedIn: http://in.linkedin.com/in/praneetsurti Twitter: twitter.com/praneet20

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