posted 15 March 2000 03:41 PM               

Don't we first have to observe a defect before we can attempt to prevent a similar one? Is it similar to the difference between corrective vs. preventive action; where corrective action is performed to correct a specific problem, and preventive action is performed on similar jobs(procedures, etc.) to prevent the problem from occurring?

Thanks for your help,

posted 17 March 2000 04:14 PM               

Thank you Marc,

posted 27 June 2000 01:29 PM               

Product and service nonconformance reports are the source of information leading to the corrective action that you should take to prevent the same or a similar problem from recurring. Situations may include the following:

Failures, malfunctions or nonconformities in incoming materials, processes, tools, equipment or facilities needed to produce your product or deliver your service, including the equipment and systems you use;

• Inadequate or non-existent procedures and work instructions;
  
• Non-compliance with procedures or work instructions;
  
• Inadequate process control;
  
• Poor scheduling;
  
• Lack of training;
  
• Inadequate working conditions;
  
• Inadequate resources, (human or material);
  
• Inherent process variability.
  

These conditions may be found by reviewing:

• Inspection and test records;
  
• Nonconformance reports;
  
• Observations during process monitoring;
  
• Audit observations;
  
• Field, service, or customer complaints;
  
• Regulatory authority or customer observations;
  
• Observations and reports by your personnel;
  
• Sub-contract problems;
  
• Management review results;
  
• Inherent process variability.
  

The same causes and conditions may indicate where preventive action is needed and where patterns or trends that may indicate the potential for nonconformities should be investigated. The degree of corrective or preventive action taken depends upon and is directly related to the risk, size and nature of the problem and its direct effects on product quality.

Corrective and preventive action reports should be part of the management review process.

Corrective action

Corrective action is taken to eliminate the cause of an existing nonconformity or other undesirable situation. There is a distinction between "correction" and "corrective action". Correction refers to repair or rework as is done to eliminate a nonconforming product situation whereas corrective action is taken to prevent recurrence of the situation.

Your procedures should describe how to implement corrective action, how it should be carried out and the effectiveness of the results verified.

It is important to implement procedures to deal with nonconformities discovered in any products that have already been delivered. You must determine whether the nonconformity is an isolated or a repetitive problem, and any actions to be taken, if necessary.

Corrective action to eliminate the cause of a nonconformity is not necessarily required every time or for isolated incidents of a minor nature, but a periodic analysis of nonconformance reports should be done to identify opportunities for process improvement.

Preventive action

It should be noted that corrective action is taken after nonconformities are identified. Preventive action is taken when a potential nonconformity is identified as a result of the analysis of records and other relevant sources of information, such as the following:

• Statistical process control documents;
  
• Customer complaints;
  
• Review product, process and quality system information,
  
• Risk analysis and risk assessment of products and processes.
  

Records relating to the product performance should be analyzed regularly, to detect trends and to identify areas of risk that may lead to nonconformities. The analyses should also determine how to prevent any identified potential problems.

Information on preventive action taken must be part of your management review to maintain and improve your quality system.

Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence of a situation or nonconformity. Preventive action is not necessarily required for all the potential nonconformities you have identified, but it should be considered if there are opportunities to improve your quality management system.

From: www.isoman.com/CorAct.htm

posted 21 August 2000 11:09 AM               

Those little white plastic tripods that sit in the middle of the take out pizza to keep the box from collapsing......and messing up the cheese.

posted 04 November 2000 06:09 PM               

From: Joseph & Susan Green

Dear List Members,

As a temporary alternative to tires, please consider the following
actual event, and comment on
1. Is it a corrective/preventive action?
2. Is it a preventive action?
3. Is it both?
4. Does it belong on the discussion list?

Occurrence: August 1999
Location: 100 man specialized tool and die facility
Conditions: Observed audit, "Certification Assessment" ISO 9002, 1994 Two auditors, two working days, the following event occurred at 3:30 PM on day one.

Senior lead assessor and his guide approached a machining center in preparation for conformity assessment of the activity in that area. As the two men entered the area an aerosol can of "bluing" sitting near the machine began to discharge it's contents vertically into space. The machine operator quickly grabbed the can and directed the uncontrolled spray into the machine oil sump.

No harm, no foul?
The auditor decided not to record the occurrence in his working notes. The auditor complimented the operator for quick thinking, they all laughed and went on with a fruitful audit interview.

The management representative learned from the auditor's guide of the event. At that point the mgt. rep. assigned someone to fetch the spent aerosol can.

The directions on the can were clearly visible, and among other user concerns was a warning not to expose the can to flame, excessive heat, and to store and use the product at a temperature range of 65F to 95F. NOTE: "August" - "Illinois" - It was 101 F outside the plant that particular day and no record was available of the interior temperature. As the observer I'll guess at 105F +/- 5.

The management representative dispatched three subordinates to search the entire facility for similar "dye" spray cans. Seventeen cans were found in various work areas. (all above 100F).

1. The spray cans were collected and moved into a air conditioned supervisors office.

2. The 2nd shift supervisor was informed verbally to use spray only if needed, and to return the cans immediately after use to the air conditioned environment.

3. The management representative typed up a "temporary" procedure for the use of the blue dye spray cans, and forwarded copies to each day shift foreman.

4. The purchasing agent was left a hand written note to investigate the purchase of an alternative product with less critical temperature constraints.

5. The management representative then documented the days "blue dye" event on a standard internal corrective action form, and then duplicated the same information on an internal preventive action form.

6. Verification of the corrective action was to visually inspect the plant for any similar dye spray cans and/or verify that replacements were obtained and/or controls implemented to ensure proper storage and use of the spray product.

7. Verification of preventive action was to implement a search of the entire plant for ANY other aerosol cans that might have a similar potential risk. (reaction dependent upon search findings).

This is an actual occurrence. I believe it represents the very best that ISO has to offer to any organization. I don't recall ever mentioning to anyone before now that this occurrence did not effect "finished product quality"

Your opinions and comments pro or con would be appreciated.

Thank you in advance

Joe Green

----------------------------

From: ISO Standards Discussion
Date: Wed, 4 Oct 2000 16:06:10 -0500
Subject: Re: Q: Corrective or Preventive? /Green/Andrews

From: [email protected]

Ole Joe wrote (in part);
> I believe it represents the very best that ISO has to offer to any
> organization. I don't recall ever mentioning to anyone before now that
> this occurrence did not effect "finished product quality"
>
> Your opinions and comments pro or con would be appreciated.

Joe,
From your post it seems that this company (or at least the management rep.) knew what they were doing. Corrective actions were implemented (removal of all blue dye cans to safe storage area and Purchasing to investigate alternate supplies). Preventive action was undertaken (entire plant was assessed for other spray cans that might have similar temperature constraints). All sounds good to me.

One question though - with the temperatures well over 100 degrees F (enough to send spray cans into premature discharge) - what impact does the temperature have on the HUMAN resources in the manufacturing areas? Is this considered a "suitable" work environment?

My 2 cents.

Ethan Andrews

---------------

From: ISO Standards Discussion
Date: Wed, 4 Oct 2000 16:16:16 -0500
Subject: Re: Q: Corrective or Preventive? /Green/Randall

From: [email protected]

> From: Joseph & Susan Green
>
> Dear List Members,
>
> As a temporary alternative to tires, please consider the following
> actual event, and comment on
> 1. Is it a corrective/preventive action?
> 2. Is it a preventive action?
> 3. Is it both?

Joe,
I enjoyed reading the events you describe below. In my opinion:

(1) IF the company's quality system requires that dye sprays be handled, stored and used in accordance with the manufacturer's instructions, then it would be a noncompliance and a corrective action would be required to bring the actual practices into compliance with the formal documented quality system.

(2) However, if the company's quality system does NOT require dye sprays to be handled, stored and used in accordance with the manufacturer's instructions (which I assume was the actual case since most company's would not document a requirement to follow such instructions), then the steps taken would be a preventive action.

(3) Whether the dye spray actually came into contact with the finished product or not is irrelevant The question is whether the quality system requires the handling of the dye sprays according to the manufacturer instructions.

According to the definitions given in ISO 8402, there must be an actual noncompliance before corrective action is taken -- otherwise, by definition, the action taken is preventive.

> 4. Does it belong on the discussion list?

I enjoyed reading something a little different from the normal type of questions / issues raised in this discussion group -- so I would say yes. I think that this type of topic / question certainly belongs in this discussion group.

Richard C. Randall

-----------------------------------

From: ISO Standards Discussion
Date: Wed, 4 Oct 2000 16:20:02 -0500
Subject: Re: Q: Corrective or Preventive? /Green/Paten

From: "Mike Paten"

Joe,

An interesting story. I'm not sure it matters whether you call this corrective or preventive - but, to me, it is clearly a preventive action - because by definition no failure occured - although the process controls in place where "barely good" enough to "detect" the condition before failure could occur!

Actually a lot of preventive actions are initiated by people who "know" that a condition exists that IS going to cause failure - sooner or later.

Mike Paten

-----------------------------

From: ISO Standards Discussion
Date: Wed, 4 Oct 2000 16:29:49 -0500
Subject: Re: Q: Corrective or Preventive? /Green/Kozenko

From: [email protected]

> 7. Verification of preventive action was to implement a search of
> the entire plant for ANY other aerosol cans that might have a
> similar potential risk. (reaction dependent upon search findings).
>
> This is an actual occurrence.
> I believe it represents the very best that ISO has to offer to any
> organization. I don't recall ever mentioning to anyone before now
> that this occurrence did not effect "finished product quality"

Joe:

I selected only "No. 7" although my opinion runs consistently throughout your post.

It was a corrective action, especially when one quick thinking operator grabbed a self-discharging aerosol can and pointed the discharge where it would do no environmental harm. Big plus.

It was a preventive action when other potential self-discharging cans were collected and placed in a temperature zone less conducive to their independent self-discharge. This was also an OHSA-flavoured safety action which I will rub under the nose of white collared engineer types who tell me ISO and OSHA don't ever mix. Balderdash.

Granted, a further preventive action would have been to air condition the entire plant. No doubt, lots of people thought of this. Perhaps one day, someone will implement it. It is a tribute to your management people that at least something was done with the remaining cans. A less satisfactory, and less safe, approach, would have been to tell everyone what to do in the event "their" can started to self-discharge. One slip-up amongst all those cans, and someone could have gotten a lung full of nasty stuff, or worse, one or both eyes...

Does it belong on this list? I'd surely say yes. It's a fine example of the theory of the standard and how it actuates into floor- and executive-behavior.

David M. Kozenko

-------------------------------

From: ISO Standards Discussion
Date: Mon, 9 Oct 2000 12:49:58 -0500
Subject: Re: Q: Corrective or Preventive? /Green/Andrews/Green

From: Joseph & Susan Green

> From: [email protected]
Ethan responded:
> Joe,
> One question though - with the temperatures well over 100 degrees F
> (enough to send spray cans into premature discharge) - what impact
> does the temperature have on the HUMAN resources in the
> manufacturing areas? Is this considered a "suitable" work environment?
> My 2 cents.

My reply to Ethan

Good catch. I hadn't thought about that one. Especially with regard to 9K2K. It leans toward "work environment" or "infrastructure". It makes me wish the "Human" and "Physical" factors had not been removed from the FDIS.

Value added comes from the improved awareness of events. (such as a spray can uncontrolled discharge) ..The point I press over and over is that no matter how immature or incompetent the organization, the more they focus energy on reality, appropriate reaction to reality, and pat themselves on the back for doing what they should have done all along, the entire world "International" gets a little better. (Hard to measure, but I still believe in ISO and it's inherent GOOD.