I'd like to combine corrective and preventive action into a POLICY document

[ChristineP - 2006]

I've been tasked with rewriting our (very bad) corrective action procedure and could really use some help as I am having to learn about quality on-the-job and under the gun.

Almost all the procedures I've researched explain how CARs are reported into a central repository where they go through the identify, document, analyse, implement and verify steps. These mostly read like a work instruction, rather than a procedure.

In our company, and I'm sure others, various departments have their own daily methods for dealing with nonconformity and initiating corrective and preventive action - without logging into a central CAR system. For example, Program Management conducts regular reviews to ensure they are on schedule, in budget, and producing the documents they are supposed to. If something is amiss, they wouldn't write a CAR - they have their own methods for dealing with it internally.

ISO requires a written procedure(s) dealing with corrective and preventive action. I'd like to combine the two into a POLICY document, stating that each department will undertake these activities (along with improvements), and what these activities should involve. This document would provide examples of the methods -- without necessarily having to list every single procedure. Then, there would be a reference to a separate document referring specifically to the automated CAR system.

So, my quesitons are:
1. Does this sound like a good idea?
2. Does anyone have a policy document to share? As I said, there isn't anything similar and I'm not sure how to structure or write it with purpose, scope, responsibility, etc, etc.

Look forward to the Cove's replies.
Christine

 

[Wes Bucey]

FWIW. Although I realize the general process of "Corrective Action" is often subjected to a rigorous and structured "prescription" of how to perform each step, I'm uncomfortable with organizations that demand the same rigor and paperwork for a "missed signature" on a certificate of conformance as they do for a foul-up in a manufacturing process that results in a ton of scrap parts. I prefer a relatively loose approach to the procedure, trusting in the folks dealing with the nonconformance to deal with and "flesh out" a bare bones outline of

1. confirm the nonconformance
2. determine the extent of nonconformance
3. make economic judgment whether to pursue matter or merely repair or replace or reimburse (some things make no sense to pursue - "customer orders and pays for 10,000 pieces of special design; you deliver 9,990. Will customer be satisfied with being reimbursed for ten pieces or does he need them desperately to complete a project? Did he really need only 9,900, but order 10,000 as a round number? Sometimes it costs too much more in time or effort than the value to the customer to start up the process to make up the shortage and the best "corrective" action is to pay the customer." The deeper problem of the faulty count is a PREVENTIVE ACTION which needn't involve the customer, but is important to the organization.)
4. If justified, perform root cause analysis and prepare scenarios for Corrective Action, taking economic benefit into account. Simultaneously examine Preventive Action scenarios and evaluate for economic benefit.
5. Implement best (effective and within budget) action
6. Evaluate whether the implementation is indeed effective
7. Report so knowledge base can be used if similar nonconformance arises in another process.

In the case of a missed signature, the immediate corrective action would be to determine if the missed signature was an oversight or whether the product was actually nonconforming. If the missed signature was just an oversight, send a signed one for "corrective" action and work on PREVENTIVE method (some sort of mistake proofing?) to eliminate the probability of the error recurring. If the missing signature was a symptom of a much deeper problem (supposed signer doesn't actually verify product is conforming?), then the MRB (Material Review Board) may have a much more extensive problem to handle. In either case, no one could devise a single Procedure to take the place of common sense and initiative of the folks on-site.

It is important to help the folks on site learn about the value of resolving problems in a way to balance the customer's needs with the economic realities of the organization and to look for the solution that will solve the immediate problem and work on one which prevent the problem from recurring. Customers do not necessarily need to be involved in the preventive action aspect unless there is a continuing order for the product or service in question.

As an example:
If I make a one-time order of fifty thousand screws and I get shorted one thousand, my interest will cease if the supplier sends the one thousand screws. His immediate corrective action was to confirm the shortage and ship me the screws. His problem is to figure out how the shortage occurred and what to do about preventing it in the future.

If I ordered 500,000 screws in ten shipments of 50,000 and got only 49,000 in the first shipment, I'd be vitally interested in the Preventive action for the next nine shipments. The supplier still has the same tasks, only I expect him to share the results of the Preventive Action exercise to assure me I won't get shorted on the next shipment.

 

[Marc]

Also see: Corrective Action (CA) and Preventive Action (PA) - One or Two Procedures?

 

[ChristineP - 2006]

Thanks for your replies, Marc and Wes. Yes, I understand that it is not necessary to create a CAR for minor nonconformities, and have already decided that we'll have only one procedure for corrective and preventive actions. What I am wondering, however, is how to structure /write a procedure which states that individual processes are responsible for setting up their own internal controls for dealing with minor conconformities and corrective actions. And when these controls fail, THEN they raise a CAR through a separate procedure which establishes all the fine details of a typical CAR system.

Whilst waiting for a response to my query, I've been trying to put my thoughts into a flowchart, which I've attached. Please note it is a VERY rough draft - still trying to collect my thoughts. I'm thinking that this would form a large part of the policy document, which, as you'lll see in the flowchart, will link to the actual procedures for when and how to create CARs/PARs.

Again, comments and suggestions will be very much appreciated!
Christine

 

[Bobh@pte]

Christine,
Through trial and error, I have implemented one form to cover all "issues that may arise". I call it the "Quality Issue Report". We have created an email system by which any employee may generate, (identify a perceived nonconformance). (Our system is 95% electronic). If the "issue" is that a customer calls and complains, the person who takes the call generates a report and submits it to me (Quality Manager). I have (6) check boxes at the top of the page:

1. Customer Complaint
2. Internal Nonconformance
3. Supplier Nonconformance
4. Preventive Action
5. Quality Management System Nonconformance
6. Internal Audit Nonconformance.

Any one or all of these may be checked at one time. Ater the relevant boxes are checked, the remainder of the form is a layout that follows the 8D's, for the most part. For example;

Section 1. (Requirement) What were we supposed to do?
Section 2. (Issue) What violation was perceived to have occurred?
Section 3. (Interim corrective Action) Has any action taken place to resolve the issue?
Section 4. (Root Cause)
Section 5. (Corrective Action) To eliminate the root cause.
Section 6. (Preventive Action) This can be used for either Proactive or reactive PA.
There are of course a couple of other areas that close the loop, c/a effectivness for example, I force department managers to close an issue that is relevant to their department.

So, I receive the perceived issues, copy and paste into a database and route the email wherever it needs to go. The answers are returned to me. I then copy and paste these into the database. This way I can control, according to the seroiusness of the issue, how much action needs to be taken. The database allows me to set up all of my reports for Management review meetings, etc... The best advise is to create a system that works for your company, one size doesn't fit all. Like the lady said, don't be afraid to stick by your system, when audited. Good Luck!

 

[Greg B]

Christine,

It sounds like you have your head screwed on and the fact that you have asked for help rather than an all out solution means that you are willing to listen to others. Great start.

Craig Cochran (a cove member) has put out an excellent book (name escapes me) that has some very simple, generic solutions to many QA issues. You might try to PM him and ask about his book.

Reading you post i get the feeling that you want to write a procedure or policy that details what everyone does whenever they have an issue that is out of the norm. Not all issues should be addressed as Non Conformances or dealt with by a CAR system. The normal day to day process issues should be dealt with on their merits (as Wes has stated). If an abnormality occurs and you think it may require further investigation then this may generate a CAR. I try to ensure that people in my organisation know that CARs are NOT negatives but a positive continuous and preventative maintenance tool that may lead to productivity benefits etc. We do have stated issue that automatically generate a CAR and they are when a Customer Complains, a Contamination Occurs or a Process Fails. We do not always raise a CAR if a product fails but rather we generate a lesser report (NC report) that has a mini investigation that may determine that it is a general process fix or it may generate a CAR because the problem may be repeated. What I am trying to say is that our system has to remain flexible. We look at each issue on its merits and determine if a CAR or NC should be raised and what the benefits would be if either was raised. Sometimes we just fix the problem and log it in the shift log so people can look back at a later date if a similar problem occurs.
This probably is as clear as MUD. It is early on a Friday morning in Australia and I am about to go on a weeks leave to clear the senses.

Look at the links at the bottom of this page and DO A SEARCH (you will be amazed at what you wil find)
.

 

[Cari Spears]

This probably is as clear as MUD. It is early on a Friday morning in Australia and I am about to go on a weeks leave to clear the senses.

It was very well put. Enjoy your vacation!!

 

[Wes Bucey]

One of the things that occur to me is that NOT everyone in an organization has to be able to complete a Corrective Action Request by completing a Report.

There is a concept often used in manufacturing organizations called a Material Review Board (MRB), usually consisting of a cross-section of disciplines within the organization (Quality, Production, Management, Engineering, Purchasing, etc. and sometimes even the customer.) The MRB looks at suspect material and is the ultimate decision maker (for the organization) whether the suspect material is, indeed, nonconforming. The MRB team (not everybody on the MRB needs to deal with every suspect case) decides how to proceed once the decision about conformance is made. The MRB has free rein within and without the organization to track down a solution. THEY make the decision about a reasonable budget in terms of time, money, and manpower to find a solution. They have the power to implement the action (corrective and/or preventive) by directing other employees, departments, or suppliers.

MRBs deal with nonconformance of incoming material from suppliers as well as products produced by the organization whenever a nonconformance is suspected. The MRB is the entity which approves or denies a Return Authorization (RA) requested by a customer when suspect material is noted at the customer's inspection.

1. First and foremost, the MRB confirms the nonconformance.
2. Then MRB decides the extent of nonconformance.
3. Then what immediate remedy is optimal (repair, return, replace, scrap, pay money.)
4. Then what long term or permanent solution may be required (if any.)
5. Oversee the implementation and evaluate its effectiveness.

In my high tech machine shop, the MRB had a very simple Procedure:
"Do whatever is necessary to resolve a suspected nonconformance using the combined wisdom and experience of the team, with free rein to use any resources necessary and with authority to implement any decisions the MRB team makes."

Could that be the ultimate empowerment?