TITLE: Corrective & Preventive Actions

<COMPANY LOGO> PROCEDURE NO.: SOP XXX

REVISION: #
DATE: M/D/Y

CORRECTIVE & PREVENTIVE ACTIONS

1.0 PURPOSE & SCOPE

1.1. This procedure establishes the process of investigating and eliminating the
cause of a problem in order to prevent occurrence or reoccurrence. A
problem is any condition or event which effects product quality, compliance,
or the effectiveness of the Quality Management System.
1.2. Sources of Corrective & Preventive Actions are listed in Appendix A.

2.0 AUTHORITY & RESPONSIBILITY

2.1. The Quality Assurance/Regulatory Affairs department is responsible for
maintaining this procedure. The QA/RA Manager is responsible for ensuring
actions taken do not have an adverse effect product quality, compliance, or
the effectiveness of the Quality Management System.
2.2. Process owners (e.g., responsible manager, responsible supplier) are
responsible for investigating problems, identifying the cause, correcting
problems, and preventing reoccurrence of problems.
2.3. All employees are responsible for identifying problems and making
suggestions for improvement.

3.0 PROCEDURE & INSTRUCTIONS

3.1. Process Overview
3.1.1. A problem is found and QA/RA is informed. QA/RA determines
the type of Corrective & Preventive Action (CAPA), lists the
relevant documents & records, and then assigns to a process
owner (e.g., responsible manager, supplier). The process owner
investigates the problem, determines the cause, and takes action
to correct the problem and prevent reoccurrence. QA/RA (or
someone independent) verifies that all actions have been taken
and are effective. QA/RA Manager verifies everything is complete
and hasn't adversely affected anything else.
3.2. SOP-XXX-Y Corrective and Preventive Action Form Instructions
3.2.1. Top Boxes (above section 1)
3.2.1.1. CAPA Type
3.2.1.1.1. Corrective Action is selected by QA/RA when
a problem is found.
3.2.1.1.2. Preventive Action is selected by QA/RA
when a potential problem is found but has
not occurred yet.
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 3.2.1.2. Reference Documents
3.2.1.2.1. QA/RA lists any audit reports, complaints,
nonconforming product reports, procedures,
or other documents related to the CAPA.
3.2.2. Section 1: Problem
3.2.2.1. The originator identifies the problem in section 1 of
SOP-XXX-Y and submits it to Quality
Assurance/Regulatory Affairs (QA/RA). QA/RA
completes this section on behalf of the originator when
the CAPA is initiated in response to an audit,
inspection, or customer request.
Question: 3.2.3. Section 2: Investigation & Identified Cause
Why does the 3.2.3.1. QA/RA assigns the CAPA to the process owner
investigation and
identification of the (responsible manager or supplier). The process owner
root cause (section will investigate the problem and determine the root
2) come before the
corrective action cause.
(section 3)? 3.2.4. Section 3: Corrective Action
Answer: 3.2.4.1. The process owner will determine what is required to
While it is true that correct the problem. Any process or procedure
section 3 will often
be completed before changes will be indicated. Note that if the CAPA is a
section 2, you preventive action then no problem has occurred and
should examine the
problem before this section is left blank.
taking corrective 3.2.5. Section 4: Preventive Action
action when
possible because 3.2.5.1. The process owner will determine what is required to
this can help you prevent the problem from happening or to make
find the cause. This
flexible sequence is improvements. Any process or procedure changes will
indicated by two thin be indicated.
black lines on the
process flowchart. 3.2.6. Section 5: Verification of Effectiveness
3.2.6.1. QA/RA will verify (or assign an independent and
objective verifier) that the required actions have been
executed and are effective. The verifier shall indicate
any evidence sampled.
3.2.7. Bottom Box (below section 5)
3.2.7.1. The QA/RA Manager reviews the CAPA and verifies
that the Corrective and Preventive Action has been
completed and does not have an adverse effect on
product, the quality system, or compliance. Once this
has been completed the CAPA is closed.
3.3. Documentation and Review
3.3.1. QA/RA assigns a unique identifier to the CAPA. The identifier is
CAPA YYYYMMDD-N where YYYY is the four digit year, MM is
the two digit month, DD is the two digit day, and N is a sequential
number beginning with 1 for the first CAPA on that date. This
number is entered on the top of the first page.
3.3.2. Corrective & Preventive Actions are entered on the CAPA Matrix.
The identifier, the type of CAPA (CA or PA), a brief description,
the process owner(s), the status (Open or Closed), and any notes
are listed.

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 3.3.3. A summary of all Corrective & Preventive Actions will be
compiled prior to and reviewed during each Management Review
Meeting.

4.0 REFERENCE DOCUMENTS

4.1. SOP-XXX-Y Corrective & Preventive Action Request

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 Appendix A: Sources of Corrective & Preventive Actions

Any problem identified during an internal audit, external audit, or inspection

Audits
requires the initiation of a CAPA.

Customer feedback, including complaints, may lead to a CAPA. Several

Customer Feedback & Complaints complaints which are similar may be transferred to a single CAPA. See SOP-XXX
Complaint Handling.

Nonconformities noted during incoming, in-process, and final inspections or

Inspection and Testing
testing. See SOP-XXX Control of Nonconforming Product.

Management Review The initiation of a CAPA may be an output of Management Reviews.

Analysis and reviews of returned items may indicate a trend and require the
Returns
initiation of a CAPA.

Suggestions for improvement can be documented through the initiation of a

Suggestions for Improvement
CAPA (this is not a requirement).

Products, materials, parts, and services not conforming to purchase order

specifications or Quality Management System requirements can be addressed
Supplier Quality
through the initiation of a CAPA. Supplier Corrective Action Requests are often
called SCARs.

Statistical methodology is employed as appropriate to control processes and

Trends and Analysis detect problems. Specifics may be found in relevant procedures. Trends may
result in the initiation of a CAPA.

Regardless of the above, any condition or event which effects product quality,
Other compliance, or the effectiveness of the Quality Management System requires the
initiation of a CAPA.

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