CAPA (Corrective and Preventive Action) Plan Templates

E

epspolymer

#1
We were recently audited by a medical company (we are not ISO certified); however, we do have a Quality system in place.

We had six findings in the audit, one major, the rest minor. They are requesting a CAPA plan for all six observations.

I have been scrounging the Internet for CAPA plan templates with no luck.

Does anyone know of a site that offers this type of template (among others)??

Please help!! :thanx:

~Joan~
 
Elsmar Forum Sponsor

RoxaneB

Super Moderator
Super Moderator
#3
If you scroll down this page, you will find a list of related threads discussing this topic.

Although, one thing puzzles me ... you indicate that your organization has a Quality system in place (albeit not registered to an ISO standard) and yet you do not have corrective/preventive action processes established? Am I reading the situation correctly?
 
E

epspolymer

#4
If you scroll down this page, you will find a list of related threads discussing this topic.

Although, one thing puzzles me ... you indicate that your organization has a Quality system in place (albeit not registered to an ISO standard) and yet you do not have corrective/preventive action processes established? Am I reading the situation correctly?
You are partially correct. We established a Quality System and have intentions of ISO certification down the road (when finances permit). However, we have some weaknesses in the system which we are trying to correct, one of them being the Corrective/Preventive Action process. What I am lacking mostly are document templates, such as a CAPA action plan, in order to respond to the auditor properly. This is a first time occurrence for us, and we lack proper experience to respond.
 

yodon

Staff member
Super Moderator
#5
Bear in mind that a template does not make the process! Understand the expectations for a CAPA system first and then the template more or less falls out of that. Blindly using a template from someone else may lead you to doing things that don't make sense for your company, for a CAPA system, or for any good whatsoever.
 

Pancho

wikineer
Super Moderator
#6
We were recently audited by a medical company (we are not ISO certified); however, we do have a Quality system in place.

We had six findings in the audit, one major, the rest minor. They are requesting a CAPA plan for all six observations.

I have been scrounging the Internet for CAPA plan templates with no luck.

Does anyone know of a site that offers this type of template (among others)??

Please help!! :thanx:

~Joan~
Hi Joan,

Are the "findings" actual non-conformities, potential non-conformities or something else? If non-conformities, are they against your contract or against something else? An advantage of not claiming conformance to a standard is that you can't be held responsible for not conforming to that standard.;)

Assuming that the NCs are indeed against your commitments: The CA (Corrective Action) part of CAPA is the modification to your processes that prevents recurrence of a non-conformity. The PA (Preventive Action) part is a modification that prevents the occurrence of a non-conformity that hasn't happened yet. In either case, they are actions that prevent future occurrences of the non-conformity. They are not the fixing of the non-conformities themselves.

In order to take effective CA or PA you need to determine the Root Cause (or root causes) of your non-conformities. To determine the Root Cause, you can use one or more methods such as the 5-whys, fishbone, or Failure Mode and Effects Analysis. These methods are often lumped together into the term "Root Cause Analysis".

Once you have determined the root cause (or causes), the corrective (or preventive) action plan follows naturally. It is what must be done to eliminate the root cause. Thus, if you know the root cause for your NCs then your plan should describe how the process will be modified to eliminate it.

If you do not know the root causes, then your plan can't really be written for anything beyond finding the root cause. If you must reply immediately, then propose that you will conduct a Root Cause Analysis of the problem, and that the plan will be further developed once the RCs are determined.

Good luck!
Pancho
 
Last edited:
Thread starter Similar threads Forum Replies Date
R Non conformance (NC) or Corrective & Preventive action (CAPA) CE Marking (Conformité Européene) / CB Scheme 7
B Corrective and Preventive Action (CAPA) A Key Process of the Quality Management System Dec 17... Training - Internal, External, Online and Distance Learning 0
K CAPA (Corrective and Preventive Action) - ISO 13485 Nonconformance and Corrective Action 1
J Software and Methods for Tracking CAPA (Corrective and Preventive Action) items US Food and Drug Administration (FDA) 3
D CAPA (Corrective and Preventive Action) Flow Chart example wanted Preventive Action and Continuous Improvement 3
Q Recommendations for criteria on creating a CAPA (Corrective and Preventive Action) ISO 13485:2016 - Medical Device Quality Management Systems 8
Q Recover a Damaged CAPA (Corrective and Preventive Action) Project Preventive Action and Continuous Improvement 6
M CAPA (Corrective and Preventive Action) Standards & Templates for Tier 1 Supplier IATF 16949 - Automotive Quality Systems Standard 4
Q CAPA (Corrective Action and Preventive Action) after Correction always? Nonconformance and Corrective Action 10
Q CAPA (Corrective Action Preventive Action) NC recommended for IT, HR, ACC.? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q Calibration Failure - CAPA (Corrective and Preventive Action) General Measurement Device and Calibration Topics 3
P When is an issue a CAPA (Corrective and Preventive Action) request? Nonconformance and Corrective Action 6
C FDA - CAPA (Corrective Action and Preventive Action) & Complaint Database 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Suggestions for a CAPA (Corrective and Preventive Action) Software Program Quality Assurance and Compliance Software Tools and Solutions 17
Q CAPA (Corrective and Preventive Action) Guidance Needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Issue Tracking and CAPA (Corrective and Preventive Action) Management Nonconformance and Corrective Action 6
Q Corrective and Preventive Action (CAPA), 820.100 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D CAPA (Corrective Preventive Action) Form for critique ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q CAPA - What criteria should be used to initiate Corrective and Preventive Actions ISO 13485:2016 - Medical Device Quality Management Systems 8
R CAPA (Corrective Action Preventive Action) Procedures Separate or Combined Nonconformance and Corrective Action 9
P Complaints & CAPA's (Corrective Action Preventive Action) for Clinical Trials ISO 13485:2016 - Medical Device Quality Management Systems 4
K CAPA (Corrective Action Preventive Action) Training Exercise Training - Internal, External, Online and Distance Learning 2
Q How to measure CAPA (Corrective Action Preventive Action) System Performance Nonconformance and Corrective Action 20
M Can this Nonconformance have suitable CAPA (Corrective and Preventive Action) Nonconformance and Corrective Action 9
Q CAPA (Corrective and Preventive Actions) - Open for how long in Medical Device field? Nonconformance and Corrective Action 4
P When to issue a CAPA (corrective action preventive action)? US Food and Drug Administration (FDA) 11
C CAPA (Corrective Action Preventive Action) example to provide training wanted Nonconformance and Corrective Action 7
V How to create a CAPA (Corrective Action Preventive Action) Database Nonconformance and Corrective Action 3
C High Level CAPA (Corrective Action Preventive Action) SOP Example Needed Nonconformance and Corrective Action 6
kedarg6500 Corrective Action (CA) vs. Preventive (Predictive) Action (CAPA) Preventive Action and Continuous Improvement 18
J What should generate a CAPA (corrective action - preventive action) US Food and Drug Administration (FDA) 16
R CAPA (Corrective and Preventive Action) Discussions are Getting Out of Hand Nonconformance and Corrective Action 41
I Example(s) of simple CAPA (Corrective and Preventive Action) forms Nonconformance and Corrective Action 11
S Top level CAPA (Corrective and Preventive Action) procedure ISO 13485:2016 - Medical Device Quality Management Systems 26
J CAPA (corrective action preventive action) Effectiveness - Medical Device Industry Nonconformance and Corrective Action 3
F Chronic Lateness of CAPA (Corrective and Preventive Action) Responses Nonconformance and Corrective Action 25
S Simple CAPA (Corrective Action and Preventive Action) Example for Training? Nonconformance and Corrective Action 8
a_bardi Corrective & Preventive action templates for CAPA in telecom industry Document Control Systems, Procedures, Forms and Templates 2
D Quality Management Book On Capa (Corrective Action Preventive Action) Book, Video, Blog and Web Site Reviews and Recommendations 4
E Audit Program and CAPA (Corrective Action - Preventive Action) Effectiveness ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Corrective Action vs. Preventive (Predictive) Action (CAPA) - A Definitive Discussion Preventive Action and Continuous Improvement 177
G Differences - Nonconformances vs CAPA, Corrections vs Corrective Actions ISO 13485:2016 - Medical Device Quality Management Systems 16
P Documentation for correction, corrective action, mini CAPA Nonconformance and Corrective Action 9
B CAPA (Corrective Action) For A Typo? Nonconformance and Corrective Action 18
M Management Team "Actions" vs. CAPA (Corrective Actions) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
C SCAR (Supplier Corrective Action Request) as part of NC/CAPA? Nonconformance and Corrective Action 3
A To CAPA or not to CAPA? Requirement to close our Corrective Actions before Audit? Nonconformance and Corrective Action 8
Q Corrective Action - CAPA - Root Cause - Not following the training procedure! Problem Solving, Root Cause Fault and Failure Analysis 13
D A true example of CAPA - Accident that show its cause and the corrective action Nonconformance and Corrective Action 8
K NCR Corrective Action vs. Systemic CAPA Nonconformance and Corrective Action 8

Similar threads

Top Bottom