Preventive Action Requirements - Do we need a written requirement?

[MarilynJ6354]

Our auditor pointed out that we need to "beef up" our preventive action process since we haven't had any documented in over a year. We have a lot of correction actions but no one is documenting preventive actions based on analysis of data, review of processes, etc. Do we need a written requirement that states a specific number per year or is this something specific to this auditor? I am thinking we just need more definition in our procedure but I would like your suggestions. Thanks!

[sberg]

I have seen a lot of preventive actions go undocumented in the places I work. My guess is that alot of corrective actions are done and most don't take the time to document similar builds or processes that could be addressed.
Example: We find and fix an issue with a build and track this on our corrective actions. We then apply the same fix to similar builds or processes that have not been sited for corrective actions. By simply documenting these fixes that happen because of the initial corrective action. Most PA systems get used a lot more frequently.

As far as writing a procedure to address quantity required. Not necessary in my opinion. Most of the time if you can just document what is actually going on then you will have more than enough actions.

[Jim Wynne]

In Reply to Parent Post by MarilynJ6354

Our auditor pointed out that we need to "beef up" our preventive action process since we haven't had any documented in over a year. We have a lot of correction actions but no one is documenting preventive actions based on analysis of data, review of processes, etc. Do we need a written requirement that states a specific number per year or is this something specific to this auditor? I am thinking we just need more definition in our procedure but I would like your suggestions. Thanks!

You don't need more definition in your procedure, you need more prevention activity. Specifying an arbitrary number of events isn't going to help. Perhaps you need to try and determine why no PA is occurring, and suggest some possible projects.

[SteelMaiden]

In Reply to Parent Post by Jim Wynne

Specifying an arbitrary number of events isn't going to help. Perhaps you need to try and determine why no PA is occurring, and suggest some possible projects.

We do exactly what Jim is proposing. We have a quality steering committee that meets every other (or every week if there is a big project requiring more frequent updates) week. As a part of the meeting we identify some of the things going on that we could document as preventive (as well as corrective) actions. Several other meetings use this tool also.

[Stijloor]

In Reply to Parent Post by MarilynJ6354

Our auditor pointed out that we need to "beef up" our preventive action process since we haven't had any documented in over a year. We have a lot of correction actions but no one is documenting preventive actions based on analysis of data, review of processes, etc. Do we need a written requirement that states a specific number per year or is this something specific to this auditor? I am thinking we just need more definition in our procedure but I would like your suggestions. Thanks!

Hi Marilyn,

Begin by identifying and listing al permanent preventive-type activities that you have in your Quality Management System. I posted a preventive action matrix some time ago here at The Cove.
Preventive Action Matrix.

Hope this helps.

Stijloor.

[Big Jim]

In Reply to Parent Post by Stijloor

Quote: (Preventative action is a very grey area.) Really? I don't see it that way. Any action you take to prevent problems is considered PA.

Regretfully, many companies do not even give themselves credit for all the great permanent preventive actions they have in place.

See attached spreadsheet.

Stijloor.

Excellent. Although it is obviously written for QS or TS, it looks to be very adaptable.

One of my clients does something that works very well to identify Preventive Actions that might have otherwise gone unrecorded. A standing agenda item for their weekly management meeting (about eight managers and about a 1/2 hour meeting) is "Have you made any management decisions this past week that should be recorded as Preventive Actions?" They capture many while they are still fresh.

A written procedure for Preventive Action is one of the six required written procedures. That should be a strong indication of its importance. The requirement for the written procedure includes " . . . requirements for . . . records of results of action taken . . . (8.5.3d). I too will cite a company if there has been no activity.

Most companies (probably all companies) do practice Preventive Action. They are just lousy at identifying it and recording it.

One last thought. Not practicing Continual Improvement (8.5.1), Corrective Action (8.5.2), or Preventive Action (8.5.3) is an absolute waste of energy and resources. In my opinion, the greatest benefit of applying ISO 9001:2000 is the management tools of these three elements. Lack of application of this is a demonstration of a lack of Management Commitment (5.1) and I'm not afraid of writing a nonconformance to wake up a lethargical management team, especially if they have not responded to earlier cites of one of the above elements.

Your auditor is trying to help you. Pay attention!

[Mark R.]

Hi Marilyn,

You don't need to define how many you'll do in a given period. This approach can actually work against you, as if you don't meet quota, you have a new set of problems, and if you do meet quota, there's an inherent, natural reaction is to stop documenting issues, thus defeating the real purpose.

I agree with the previous responses to your question; you probably have plenty of preventative action occuring within your organization. The trick is to make sure it's identified and documented. Make sure however, that if it's documented, there needs to be adequate follow-through.

I've been in the exact same situation (in a past life). Make sure your Management Review does a really thorough review of opportunities for preventative action (or lack thereof), and any actions taken. In the absence of more formal documentation, the fact that this was at least being considered by the organization during their management review may bring you some degree of compliance, provided that you haven't written yourself into a corner with your QMS procedures.

Hope this helps,

Mark

[Helmut Jilling]

In Reply to Parent Post by Stijloor

Hi Marilyn,

Begin by identifying and listing al permanent preventive-type activities that you have in your Quality Management System. I posted a preventive action matrix some time ago here at The Cove.
Preventive Action Matrix.

Hope this helps.

Stijloor.

I would be reluctant to use that matrix, Stijloor. There are a lot of good activities on that matrix, and they are generally preventive things, but it would be difficult to fit them into clause 8.5.3. There is a format in cl 8.5.3 that directs toward a certain focused Preventive Action activity, and defines a certain structure to it (the same structure as Corrective Action follows).

The other things are very worthwhile in their own rite, but they have their own clauses, and fit better into cl 6.2.2, 7.3, etc.

Cl 8.5.3 has a specific purpose, and I encourage people to understand it and apply it.