Need examples of Preventive and Corrective Actions (Need to correct audit findings)

Lorenzo36

Starting to get Involved
#1
Need examples of Preventive Actions and Corrective Actions. I'm new with XYZ Company (2 1/2 wks) and the Quality Dept. was poorly maintained. Last week we had a Re-audit and 2 of the 7 findings were related to C/A and P/A. The corrective action finding was "MAJOR" and the Preventive a "MINOR". I only have 30 days to implement our corrrective actions, so I'm in need of some help.
 
#2
Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Need examples of Preventive Actions and Corrective Actions. I'm new with XYZ Company (2 1/2 wks) and the Quality Dept. was poorly maintained. Last week we had a Re-audit and 2 of the 7 findings were related to C/A and P/A. The corrective action finding was "MAJOR" and the Preventive a "MINOR". I only have 30 days to implement our corrrective actions, so I'm in need of some help.
What standard (e.g., ISO 9001)? When asking for help with audit findings, you'll get better help if you post the exact text of the auditor's findings. Because you describe this as a "re-audit" (a surveillance audit, I presume), your company was probably doing OK with CAPA at some point. Let us know what the auditor said.
 

Lorenzo36

Starting to get Involved
#3
Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Sorry, ISO9001/AS9100, and no the company was never ok with CAPA, there's absolutely no records of CAPA, no log, no nothing. The company received their first Certification in 2005 and the previous manager did a horrible job of maintaining the Dept.
 

AndyN

A problem shared...
Staff member
Super Moderator
#4
Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Sorry, ISO9001/AS9100, and no the company was never ok with CAPA, there's absolutely no records of CAPA, no log, no nothing. The company received their first Certification in 2005 and the previous manager did a horrible job of maintaining the Dept.
I'm guessing your AS9100 registrar recently lost their accreditation. Time to change registrars????;)
 

Lorenzo36

Starting to get Involved
#5
Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Actually, no, but I do believe we WILL (lose our certification) if we don't do well when the auditor retrurns for the Follow-up in 30 days (last chance for the company).
 

Wes Bucey

Consultant/Advisor
Moderator
#6
Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Sorry, ISO9001/AS9100, and no the company was never ok with CAPA, there's absolutely no records of CAPA, no log, no nothing. The company received their first Certification in 2005 and the previous manager did a horrible job of maintaining the Dept.
First things first. Welcome to the Cove!:bigwave:

I've looked back through your previous threads and read your Profile, so I do NOT think I'm going out on a limb here by saying,
"Despite your title of Quality Manager, you are pretty green when it comes to ISO stuff and probably pretty green about many of the so-called "tools of quality" in general!"

The basis for AS9100 IS ISO9001, meaning there is no major difference in what is required, just a few more details in AS9100. Thats OK! We can help you best once we know your true situation.

I presume from the way your posts have been going, that no one else in the company has much of a clue, either.

Lack of records suggests no internal audit plan and most likely no internal audits have EVER been performed. Questions about Configuration Management suggest you are not clear on the basic premise. I have written extensively on Configuration Management here in the Cove. You can use the Advanced search function here to browse through the posts, but here's a "quick and dirty."
The term for the process you are trying to get under control is "Configuration Management." You should Google that term for other insight into the process.

The basis of Configuration Management is to do the following, more or less simultaneously:
  1. go through a formal process of revision and approval when you change any aspect of the part or document
  2. make a determination about the compatibility of the changed part or document with all the other Allied Documents (a specific term)
  3. determine if any of the Allied Documents must be revised to be compatible in form, fit, or function with the original changed document
  4. notify all parties who may be concerned about the change and get acknowledgment that change is implemented and obsolete documents or processes are withdrawn
  5. monitor the process to ensure all the changes work together
That may seem overly complicated. Let's explore a very simple change and see how the steps above would fit in.

One of my favorite examples I frequently use (to carry a premise of saving on assembly cost) is switching from Phillips Head fasteners to Torx drive or square drive fasteners for more efficient assembly. (Form and Fit of thread profile and length are the same, fastener Function remains - service personnel may need notice to add Torx driver to kit, but can replace with current stock of Phillips head)

On the surface, this is a simple change, but consider:
  1. organization needs to make a formal document change on the part, checking and approving the change.
  2. We check the compatibility with the mating parts, but we also have to
  3. change work instruction, assembly tools, inventory (use up old inventory first?), purchasing (same or different supplier? same or different price?), repair instructions sent to field personnel, pricing on the final product, advertising, etc.
  4. notify all parties - quality inspectors, assembly workers, quality inspectors at customer, suppliers, inventory clerks, repair stations, decide whether repair stations can continue to repair with Phillips head in inventory or must implement new Torx, decide whether recall is necessary to change out old parts,
  5. continue to monitor how all parties adapt to and implement change and decide whether further modification of any of the steps is necessary
All of us go through these steps consciously or unconsciously. The key is to do the steps purposefully and consistently and to record the steps as they are completed to assure optimum efficiency. (It would be foolish to scrap or sell off all the old Phillips head fasteners and order in all new Torx ones, only to discover no one had thought to order new Torx drivers.)
Dealing with CA/PA is similar. What the Standard is suggesting and customers EXPECT is the registrant to a Standard be systematic in the approach to a Corrective Action (changing a process which produced nonconforming material to eliminate the cause) and then RECORDING what it did during that systematic approach and, further, that it followed up by EVALUATING the effect of the Corrective Action to assure it worked and continues to work.

The PA (Preventive Action) is essentially planning a process to eliminate as many of the possible causes of nonconformance as possible, or, failing that, to have a method to detect nonconformances BEFORE they reach a customer. In a lot of companies, PA is an outgrowth of the Failure Mode & Effects Analysis (FMEA) process they deploy in planning a process. The essential point here is like everything in adhering to a Quality Management System Standard:
  1. Document the plan
  2. Follow the plan
  3. Record that you follow the plan
  4. Evaluate the plan to assure it is effective
  5. Record the evaluation
  6. Based on the evaluation: leave as is, correct lapses, or make new, more effective plan
  7. Keep a record that you are doing this on a regular, continual basis
Based on what you've told us so far, I have a strong hunch your company is also woefully deficient on Management Review as a natural part of Internal Audit. Please enlighten us.
 

AndyN

A problem shared...
Staff member
Super Moderator
#7
Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Actually, no, but I do believe we WILL (lose our certification) if we don't do well when the auditor retrurns for the Follow-up in 30 days (last chance for the company).
Lorenzo, I was thinking that any CB who would let your company maintain registration (to AS9100) and yet be so deficient in these areas, isn't worth dealing with. They are culpable in letting this system deteriorate (if it was totally compliant in the first place.......)
 

Lorenzo36

Starting to get Involved
#8
Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Bucey, yes I guess you could call me "green" and would agree. Why do I agree? Because in my 16 yrs of Quality I've never have had to correct so, so, so many problems. It's not just problems on the "surface", they go beyond that. So for me, this by-far is my biggest challenge yet! AND I have to correct all this in such a short time (30 days), so as you can see I'm under alot of pressure. I guess I was spoiled at my previous jobs, all I did was maintain the department, everything was always up-to-date and organize. Yes, certain areas of the standard (AS9100) are new to me (configuration management), which is why I'm on this website asking for help. You, Andy and certain individuals have been very helpful. Considering the circumstances, in the end I believe in myself, I'll get this "thing" turned-around for this company. Thanks.
 

Wes Bucey

Consultant/Advisor
Moderator
#9
Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Bucey, yes I guess you could call me "green" and would agree. Why do I agree? Because in my 16 yrs of Quality I've never have had to correct so, so, so many problems. It's not just problems on the "surface", they go beyond that. So for me, this by-far is my biggest challenge yet! AND I have to correct all this in such a short time (30 days), so as you can see I'm under alot of pressure. I guess I was spoiled at my previous jobs, all I did was maintain the department, everything was always up-to-date and organize. Yes, certain areas of the standard (AS9100) are new to me (configuration management), which is why I'm on this website asking for help. You, Andy and certain individuals have been very helpful. Considering the circumstances, in the end I believe in myself, I'll get this "thing" turned-around for this company. Thanks.
Don't panic. 30 days is plenty of time to show you are "on track" to correcting the NC list presented by the auditor. With a good documentation that you ARE working on fixing the system, most registrars will give you an extension as long as it appears you are making progress and have actually fixed one or two of the more glaring deficiencies.

Tell us about the bosses/owners of your company. Are they on track to help you, regardless of whether they are "quality savvy" or do they give you the impression they are dumping everything in your lap?

If they are dumping everything in your lap, you have to make it clear you need authority, cooperation, and budget to fix things or it will be impossible for anyone (even pros like many of the folks here in the Cove) to salvage your AS9100 certificate of registration from a reputable registrar.

Don't hesitate to tell them you have hooked up with a great source of help here in the Cove. We can guide you and your bosses back to "the way" [Tao.]
 

AndyN

A problem shared...
Staff member
Super Moderator
#10
Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

It occurs to me that the 30 days is normally for submission of the plan, not the whole 9 yards of actions. Of course they can take longer than the 30 days to implement, so that should give you some relief.
 

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