Effective CAPA harmonization in ISO 9001:2015 Standard

I believe the major reason of success for any organization is the outlook about how they react to their problem, mistakes or abnormalities.

CAPA helps us to simplify the above statement

WHAT IS CAPA?

Corrective & Preventive Action process is a structured, formalized way to investigate NC and determine appropriate corrections, corrective actions and preventative actions and measure their effectiveness. These are improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations

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

CAPA REQUIREMENT IN ISO STANDARDS

 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.

CAPA IMPLEMENTATION FLOW CHART:

1.    INITIATE CAPA: INPUTS

• § Customer Complaints
• § Nonconforming Product/ Process ( Defects, Delays, Waste, Mistakes, Unexpected Outcomes)
• § Audit NCs
• § Cost Reduction Effort
• § Audits
• § Suggestions
• § Continuous Improvement Effort

• § Supplier Performance
• § Accidents
• § Equipment Monitoring
• § Process Controls
• § Cost Reduction Effort
• § Audits
• § Suggestions
• § Continuous Improvement Effort

2.    PROBLEM DEFINITION

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.

3.    CORRECTION

Immediate actions taken for temporary closure of the problem and streamlining the process. The very next step after initiating correction is to investigate other platforms at risk & applying a preventive barrier to it

4.    INVESTIGATING ROOT CAUSE

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.

Define method of investigation of root cause

?      Is/Is Not,

?      Cause and Effect,

?      5 Why’s, etc.

Focus on

Facts finding, not fault finding !

what is wrong, not why it’s wrong

5.    SOLUTION/ACTION PLAN

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

6.    VERIFY/ PILOT RUN

Verify the outcomes of the Action plan with a Pilot Run or Feasibility Test before Implementing

7.    IMPLEMENTING CORRECTIVE ACTION

Action taken upon fixing the root cause for that particular Problem is Corrective Action

a.      Implementing a verified solution

b.     Testing during formation of action plan

c.      Validate

d.     Tracking (where, how many, who)

e.     Keep Retainable Documented Information

8.    EFFECTIVENESS MEASURE

The implemented actions needs to be checked for its effectiveness on frequent basis, which in turns is measurable in terms of quality, quantity, Impact & Frequency of Occurrence

? 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

What are the symptoms of a less effective CAPA system?

• Recurring issues
• Resources ($$$) are spent on “handling” failure rather than learning from it and preventing “more of the same”
• Field issues

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?

9.    IMPLEMENTING PREVENTIVE ACTION

Implementing the same action for the other platforms at Risk is Preventive Action

Correction, Corrective Action & Preventive Action at a Glance

10. CAPA CLOSURE

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

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

Changes needs to be done in all the documented information of the system

Risk Management Documented Information to be updated with preventive action taken as a potential risk

CAPA TEMPLATE

Below is a CAPA template prepared in accordance with the requirement as stated in the New ISO 9001:2015 Standard.

DATE

RCA NO.

PROBLEM DESCRIPTION What, When, Where & Effect in terms of Delay/ Cost

SCOPE Department

TEAM INVOLVED With one Team Leader/ Mentor & Rest Brain Storming Team

OTHER PLATFORMS AT RISK Similar conditions which are potential to the same problem

CORRECTION Immediate actions taken for temporary closure of the problem

ROOT CAUSE ANALYSIS Five Why Analysis/Cause & Effect Diagram

Root Cause Summary:

CORRECTIVE ACTION Action Taken for Closure of Root Cause

EFFECTIVE DATE OF IMPLEMENTATION Date of Practical Implementation of Corrective action

EFFECTIVENESS MEASURE Any Retain-able Documented Information [Record] Generated on the basis of the CA taken.Or any Checklist or Checkpoint measured on regular interval to seek for any kind of repetitive disorder

PREVENTIVE ACTION Action Taken on Platforms at Risk

CLOSURE DATE After Successful effectiveness measure,

Updating all the relevant SOPs/ Quality Norms/PFDs or any change in the system.

SIGNING OFF CAPA Signature of all the members involved in the RCA

CAPA TRAINING Attendance Record of the training given to staff regarding the CAPA implemented for their knowledge

NOTE: Many reference have been taken from Books & Internet for better explanation.