Preventive Action Initiation - A program to identify and process Preventive Actions

[Ric Schuster]

Greeting all. Let me first say that this is a wonderful place to find a great deal of valuable information. From what I have read over the past week or so, there is a very large knowledge base here just waiting to be tapped. That being said, I've searched the forums and the web quite extensively and cannot seem to find any help for my issue at hand.

I'm currently working for a very large (8000+ employees) company with multiple plants and site locations. The Quality department alone is nearly as large as the entire plant where I previously worked and is responsible for company-wide processes and procedures. One of my current assignments is to design a program to identify and process Preventive Actions. We have a good procedure that clearly defines how the CAPA process works, is administered and tracked, but like everywhere else I have looked it does not specifically explain how a potential PA is identified and initiated (CAs are pretty cut-and-dried). This was not much of a problem in my last job because the operation was small and everything went through me (as QA Manager), and in most cases I was the one pushing folks for PA ideas. The shear scale of the operation here makes this manner of initiation impossible.

I'm good with the process of initiating PAs from FMEAs (the team and/or responsible person for the FMEA will initiate) and internal audits (the auditor is responsible for initiating CARs for findings and PAs for OFIs). I'm struggling with Management Review and other negative trend-type data. It's easy to say that this type of data will be reviewed and PAs will be initiated when negative trends are observed, but who will do the initiating? Experience has taught me that unless specific responsibilities are assigned, very little will actually happen, especially when it comes to preventive actions, and even then it takes the QA folks to push for documentation.

How is this process clearly defined in other larger companies and operations out there where there are multiple layers of management? Does anyone else have more "meat" to their procedures other than "...PAs will be inititated for the following reasons..."? My boss is looking to bechmark other companies and implement best-practices, but so far I have not found anyone else having a process defined in any more detail than we currently have. Your suggestions and ideas would be greatly appreciated.

[Jim Howe]

I think you ask a great question. Although our procedure identifies that the MRC (management review committee) will review all this good data and generate PA it does not state who specifically will do it.
As I toss it about in my brain box my first thought is that the one to intitiate the PA would be the Chairmen of the MRC or the MR (management representative). I am very interested to hear from others on this.

[Wes Bucey]

Welcome to the Cove, Ric!

Great question to start things off.

In my experience, the larger the organization, the more likely the process for preventive action (changing a process to prevent occurrences of a nonconformance regardless if there have actually BEEN any nonconformances) will follow these basic steps:

1. an individual spots an opportunity for preventing a nonconformance
2. individual reports opportunity formally or informally to a designated person or to a committee which will appoint a designated person to investigate
3. designated person explores potential of the idea (up to and including a model DOE [Design of Experiments])
4. designated person reports results of investigation to management committee which may allocate funds to implement or determine not enough economic benefit can be derived.
5. a report goes back to the initial individual regarding final action/no action

In addition, the best organizations have a formal communication process to inform affected parties of pending investigations and results of those investigations to avoid repetitive suggestions or to elicit ideas to enhance the original proposal.

[Jim Howe]

I couldn't agree more Wes. We have, as most companies do, and ECR (Engineering Change Request) system and one of the triggers for writing an ECR, besides your usual "correct drawing, service request, etc", is "PRODUCT IMPROVEMENT" and any employee can call on me to document any idea for product improvement. Works pretty well for us.