CAPA Management – Part 1


CAPA (Corrective and Preventive Action) is a deviation management process that focuses on the systematic investigation of discrepancies, adverse events, or failures.

If used correctly, the CAPA process will provide a means to prevent the deviation from recurring.


•It provides a structured platform to conduct an
systematic investigation of the deviation.
•The investigation provides the means to develop a
permanent corrective action
•It provides a framework for documentation that the corrective actions are indeed effective.

Additionally, a CAPA system is the cornerstone of the organization’s Quality Management System (QMS).
21 CFR 1271.160(a) states:
General. If you are an establishment that performs any step in the manufacture of HCT/Ps, you must establish and maintain a quality program intended to prevent the introduction, transmission, or spread of communicable diseases through the manufacture and use of HCT/Ps. The quality program must be appropriate for the specific HCT/Ps manufactured and the manufacturing steps performed. The quality program must address all core CGTP requirements listed in §1271.150(b).


An action taken to eliminate the root cause and symptom of an existing deviation or nonconformity to prevent recurrence

This is a REACTIVE action that eliminates problems identified in products, services, or processes and takes care of the immediate problem.

This is an action taken to eliminate the potential causes of a nonconformity, defect, or other undesirable situation in order to prevent occurrence.

Corrective Action

An Immediate Corrective Action is essentially a description of the steps taken to gain control of a situation or product immediately following the discovery of a deviation.
The immediate corrective action keeps the deviation’s scope from expanding. It also quickly resolves or corrects a discovered event, problem, or situation until the root cause is determined.


–Removed from Service

–Manufacturing Suspended
–Test Results Withheld
–Recovery Procedure Halted


This is a PROACTIVE action which avoids deviations through planned activities. It also eliminates or reduces the recurrence of the problem.

Steps in a CAPA Process

Discovery of the Deviation
Documentation of the Events
Immediate Corrective Action
Investigation of the Root Cause
Causal Analysis
Corrective Action
Effectiveness Evaluation

Means of Detection of a Deviation

–External Audits
–Internal Audits
–Staff Observation
–Performing a task
–Inspection or Testing
–Process and Equipment Monitoring
–Record Review
–Change Control
–Material Review Boards
–Adverse Events
–Product Returns or Recalls
–Notification by a customer or a client

Document the Deviation

The objective is to create a document that is an accurate, complete description of the event so that anyone can understand it.
–External Auditors
–Internal Auditors
–Technical Staff
–Administrative Staff

Essentially, the document should contain all the details needed, without the use of jargon.

To create a well documented and effective narrative avoid the use of subjective, fuzzy, or longwinded statements.

Other documentation considerations:

–If it isn’t documented, it didn’t happen
–If it isn’t documented, it doesn’t exist.
–Precise, economical word usage

In describing the facts of the deviation, include accurate descriptions of the following details:
–What was discovered?
–Who was involved?
–When did the event occur?
–Where did the deviation occur?
–How was the deviation discovered?
–How frequently does the process occur?

Root Cause Analysis Principles

•Understanding of how or why the deviation occurred.
•Understanding of the circumstances at the time of the deviation
•Determination of other products, processes, or individuals were involved
•Gathering of data to aid in the accurate future determination of a root cause and development of corrective action.

As Part of the Investigation you must perform

•Interviews of Staff, Customers, Suppliers
•Review of Policies, Procedures, Forms
•Records Review:

Security (Room Entry)

The high level objectives are to:

•Discover the primary (root) cause
•Result in recurrence prevention
•Reduce operational risks
•Improve operations
•Maintain quality and compliance

•The conclusions derived from a RCA must be the result of a systematic process which contains well documented evidence.
•Any given problem will have more than one root cause.
•To be effective, the RCA must establish all known causal relationships between the root causes and the defined problem.
•Performance improvement measures directed at root causes are more effective than treating the symptoms of a problem.

A thorough investigation will provide the needed information to establish the root cause.
The following questions are useful in gathering data during a Root Cause
Analysis (RCA).

–Who was involved in the deviation?
–What was the deviation?
–Where did the deviation occur?
–When did the deviation occur?
–How did it happen?
–How frequently does it happen?

The questions serve to capture the maximum amount of detail regarding the deviation or occurrence. They help provide data to understand why the deviation occurred.

The Root Cause Analysis is also aided by asking questions that relate to barriers to deviation.
–Describe any physical, organizational, or process barriers in place to detect deviations.
–Were the barriers were in place?
–What was their level of effectiveness?
–Describe any barrier failures.

Are there environmental problems?
Are the work conditions suitable?
Are there process flow problems?
Are there facilities problems?
Are there any equipment or materials problems?
Are instructions for use clear?
Are there problems with staff communication or staff training?
Is there adequate supervision?
Are there problems with the methods, SOPs, forms, or task analysis?
Do the steps performed match the operating procedures?
Has a process recently changed?

Use a Recongnized Method of Problem Solving

Consistent application of one or more of these problem solving tools along with the questions mentioned will provide a good platform to arrive at an accurate determination of root cause or causes.

•5 Whys
•Pareto Analysis
•Causal Factor Tree Analysis
•Barrier / Change Analysis
•Task analysis

For more information Download our Troubleshooting and Investigation Guide here or contact us at

Part 2 of CAPA Management coming soon………..

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