"Non-traditional" Corrective Action Procedure

M

MeganM

#1
My company does document translation, and our corrective action system is not very active or effective at present. We have a corrective action form (CAF) to fill out, but employees don't fill it out. When someone from management receives a CAF, they don't always act on it in a timely manner. For example, our COO says that the CAFs focus on one aspect of a larger problem and she'd rather just fix the larger problem without being slowed down by the form. Personally, I wonder if they just want to skip steps like root cause analysis and verification- but at the same time I see their point.

Some key observations made by our President:

  • The way that we normally resolve “problems” is much faster than what is required by our CPAR process.
  • Our CPAR form drives our resolution process.
  • Employees may not be motivated to write new CPARs because of lack of communication about progress, etc.
  • Many CPARs have been related to complex process issues which can’t be resolved quickly. Other CPARs represent a piece of a much bigger process change that’s already in the works.
I am trying to dream up a new way to do CA that matches the way we resolve problems and meets the requirements of 8.5.2. Perhaps a form is still needed for documentation- but if anyone has an alternate way to document CA I'd love to hear about it. Perhaps instead of assigning a form to an individual, I could let everyone know about a CA and solicit members for a CA resolution committee? Any ideas out there for a different CA paradigm?
 
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R

rclanzillotto

#2
In my CAPA system I have two types of forms. Problem reports and Issues. One Issue can have several PR's feeding it. The PR resolution can be subject to the resolution of the Issue which is usually more complex and will take longer. For smaller items the PR can be resolved without an Issue item being created. The immediate problem is often handled via the PR with the root cause addressed in the Issue item. This allows me to close out the PR's either in their own right or by reference to an Issue item which is expected to be longer term. Best Rich
 
V

ValleyGirl

#3
Now this is a topic I would like to follow. I hope that you get some good response. The conventional corrective action process is time consuming, often with nominal results.
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#4
The one thing you do not want to minimize is documentation in the process. You can make it as efficient as possible (check boxes, links to photos, etc.) but do not shortcut the process in search of phantom efficiencies, as you will lose valuable history.

Much like physical therapy, some things are painful even when done right.
 
M

MeganM

#5
Thanks to everyone who has chimed in so far!

The one thing you do not want to minimize is documentation in the process.
I totally agree. I think people would have an easier time documenting if the form helped them to organize and solve the problem. Checkboxes are a great idea. I also really like Action item lists. If you search all the attachments on this site, there is an Action Item Log that caught my attention. It had the following categories: Date issued, Action Item, Category, Root Cause, Person Responsible, Target date, Action Taken, Status, Record of Effectiveness, Date closed. Perhaps instead of a single form, we could have a similar log (maybe in Wiki format so you can see who writes what) that everyone in the company can see. That would allow people to see the progress that is being made (or not) on their issue.
 
M

Mike Scott

#6
....I am trying to dream up a new way to do CA that matches the way we resolve problems and meets the requirements of 8.5.2. Perhaps a form is still needed for documentation- but if anyone has an alternate way to document CA I'd love to hear about it. Perhaps instead of assigning a form to an individual, I could let everyone know about a CA and solicit members for a CA resolution committee? Any ideas out there for a different CA paradigm?
Take a look at this. Good evidence linking document control, noncomformities, training and improvements.

//elsmar.com/Forums/showpost.php?p=135973

Mike :cool:
 
Last edited by a moderator:
J

JaneB

#7
Megan,

I've seen many very effective systems that avoided the use of forms altogether. If the sole use of the form is 'so we have records in a standard format that we're all used to', then I think that is a poor reason. (Pace those people for whom forms work very well).

A few examples:

* CA and PA tracked via normal (scheduled) meetings - logged as an action, reported on & thus tracked through to closure, review by team/manager.

* Use of an online system (custom built) that included CA/PA as part of process loop

* Using browser-based online systems (eg, SharePoint, accessed by people in multiple locations) to raise an action, someone to assign it (assuming it should be actioned), owner updates & ultimately closes it, review by senior manager.

If forms aren't working, I'd strongly encourage you to keep thinking for alternative methods that WILL work for you.
 

jkuil

Quite Involved in Discussions
#8
Not every non-conformance needs to be fixed with a thourough CAPA investigation.

Recently drafted a CAPA procedure for a company which deals with the CAPAs at two levels:
  1. At an engineering level when the CAPA is a simple action (e.g. single document change) to a straightforward (obvious root cause) non-conformity which has a broadly acceptable risk or an as low as reasonably possible risk
  2. At management level when the CAPA is complex and needs a project approach or additional resources. Also when the root cause is not straightforward or the risk is inacceptable, the CAPA needs to be managed at management level

The extend of the documentation required is different at both levels, e.g:
  • At engineering level a root case statement is adequate - at management level the root cause investigation needs to be documented
  • The engineering level includes a simple risk questionaire for management escalation - at management level a risk analysis and evaluation is required
  • At management level for inaccepatbale risk issues a effectiveness monitoring period procedes the implementation of the action, which is not required at engineering level

This makes the CAPAs manageable and ensures management focus on the serious issues.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#9
My company does document translation, and our corrective action system is not very active or effective at present. We have a corrective action form (CAF) to fill out, but employees don't fill it out. When someone from management receives a CAF, they don't always act on it in a timely manner. For example, our COO says that the CAFs focus on one aspect of a larger problem and she'd rather just fix the larger problem without being slowed down by the form. Personally, I wonder if they just want to skip steps like root cause analysis and verification- but at the same time I see their point.

Some key observations made by our President:

  • The way that we normally resolve “problems” is much faster than what is required by our CPAR process.
  • Our CPAR form drives our resolution process.
  • Employees may not be motivated to write new CPARs because of lack of communication about progress, etc.
  • Many CPARs have been related to complex process issues which can’t be resolved quickly. Other CPARs represent a piece of a much bigger process change that’s already in the works.
I am trying to dream up a new way to do CA that matches the way we resolve problems and meets the requirements of 8.5.2. Perhaps a form is still needed for documentation- but if anyone has an alternate way to document CA I'd love to hear about it. Perhaps instead of assigning a form to an individual, I could let everyone know about a CA and solicit members for a CA resolution committee? Any ideas out there for a different CA paradigm?
Are the actions being taken without these forms effective?

Here's the deal: the corrective action process should belong to the people who use it, not the people who think we know best how to manage it. Notice I said we... that includes me.

I have been able to explain to my people that the external auditor wasn't happy about the lack of evidence of problem solving and arriving at root cause. So we wrote a corrective action process (it had been buried in the audit process document) that defines risk levels and the different program expectations for documenting how they are being addressed, and the forms for doing that.

This process took about a year. That's a long time! But I personally took the document around to upper management and middle managers so they could give me their impressions and suggestions, which I then used to edit and finalize the process. I worked to keep their part of the paperwork as simple and direct as possible. That means, as auditor, I fill out most of the form. I also file away copies of meeting minutes, etc., that show the progress and actions on big fixes being done with projects.

It's been in use for a few months now, and is going pretty well. That has required my doing my part, in sending the CAR to the owner's manager if it's not being dealt with in the time frame defined by the plan.

So what's the right thing? I suggest you point out what your requirements are - I take it you are registered to some standard - and work with the users to define and then follow a process that will pass the smell test and serve the business objectives.
 
J

JaneB

#10
Great advice and great post Jennifer.

How very right you are that
the corrective action process should belong to the people who use it, not the people who think we know best how to manage it.
And a great example of working to resolve a sticky problem with a process and coming up with one that does now work well for the people who use it.
 
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