Developing Plans for Corrective Actions for Audit Non-Conformities

J

jbdominguez

#1
I am new to my organization, and new to the field of quality. I have an audit in a couple of weeks and no work has been done to correct the non-conformities that were documented during the last audit. I recently was involved in a training course, and the instructor advised me to make a plan to address the non-conformities. What format should the plans be in? Should these plans be controlled? Is there a standard format for plans like these? Any help would be appreciated.
 
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Statistical Steven

Statistician
Staff member
Super Moderator
#2
Re: Developing Plans for Non-Conformities

I don't think there is any standard method for documenting the plan. Depending on your documentation system, it can be a memo to file that outlines the plan. I would personally write a memo to the management representative addressing the NCs and the remediation plan. It can also be documented at the Management Review when it should have been discussed.
 

qusys

Trusted Information Resource
#3
I am new to my organization, and new to the field of quality. I have an audit in a couple of weeks and no work has been done to correct the non-conformities that were documented during the last audit. I recently was involved in a training course, and the instructor advised me to make a plan to address the non-conformities. What format should the plans be in? Should these plans be controlled? Is there a standard format for plans like these? Any help would be appreciated.
Rather than the format, you should focus on the contents concerning with a corrective action plan.

It should include actions to fix the non conformities , with related response coordinator as well as due date.
The more it is detailed , the more the document will be useful.
You can use the file a work and living document to monitor the progress of the action.
The corrective action is that the one which fixes the action with regard to the indentified root cause.
In the meantime the action plan is implemented , you should also provide a containment action or interim action to treat the non conformity.
After a certain time , you should also check the effectiveness of the corrective action and this is responsibilty of the audited organization.
As to the control of this document, it depends on what your procedure of document control states.
However , it is important to have this record enclosed with the associeted non conformity so that the organization can have traceability of what it has been done.
Another suggestion could be the one to use project managment approach for the corrective actions that needs more efforts and resources from the organization. hope this helps:bigwave:
 
A

ab001

#4
I am new to my organization, and new to the field of quality. I have an audit in a couple of weeks and no work has been done to correct the non-conformities that were documented during the last audit. I recently was involved in a training course, and the instructor advised me to make a plan to address the non-conformities. What format should the plans be in? Should these plans be controlled? Is there a standard format for plans like these? Any help would be appreciated.
I'm trying to bring this concept to my organisation, a concept that should apply to all "calls to action" - be it a corrective action request, a kaizen blitz or a year-long improvement initiative.
The concept comes from the military. [I am completely confident that the military knows how to do leadership and communication effectively.]
Using a system like this means less time thinking about how to communicate and more time thinking about how to solve the problem.
In order to give an effective command, the leader must cover five things:
Situation- why are we here, what else is going on
Mission - what are we going to achieve
Execution - what steps are we going to take
Admin - what support is available (e.g. you define what records you need)
Control - who's in charge, what's the chain, ...

You could define your plan in as little as five sentences (or four sentences and a numbered list for the execution steps).
Or a large project charter and management plan.

I usually change the terms to match business.
Background, Goal, Actions, etc
 

sagai

Quite Involved in Discussions
#5
Hi,
please read this first:
http://www.ghtf.org/documents/sg3/sg3_n18.pdf

the plan as minimum shall contain:
1., the finding/suggestion
2., the investigation
3., Root Cause analysis
4., the evaluation of the non-conformity's effect on product safety and effectiveness
5., the actions planned for:
- correction
- corrective action
- preventive action
based on the result of the Root Cause analysis
6., the protocol for the effectiveness check
7., the planned date for the effectiveness check

and one more thing ... you already have to have a procedure for CAPA describing the answer for your original post in your company QMS.

br.
Sz.
 
Last edited:
F

FMS-Steve

#6
AUDITEE PLANNED ACTIONS, my question is this when submitting the corrective action to your auditor it a plan, "telling him this is what we plan on doing" for his approval, or do you have to have the plan in place for his approval.
 
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