Example Corrective and Preventive Action procedures needed

[qualeety]

anyone has an example of CA/PA procedures for the following situation..

this company does inspection for the other companies....it follows customers' procedures...all work instructions are a carbon copy of customers' procedures....the company issues inspection reports to cutomers without any recommendations. (a customer requirement....they don't want see any recommandation....yah yah, bite me).... the inspection results varies from time to time......the company has almost ZERO influence on the customers' performance....any CA/PAs are done by the customers with or without informing the company....and it does not matter to the company since it only does inspections regardless of good or bad......there is no process of CA/PA related to the inspection procedures since it follows customers' procedures (even if they are wrong, the company follows WRONG procedures as long as they does not endanger the employees)....the company is doing what customers want, nothing more nothing less........continual improvement can be made on the timing and delivery ....but CA/PA? :truce:....yikes



In this situation, can there be CA/PA procedures?...recognizing CA/PA portion cannot be omitted for ISO registration....been banging my head against the wall on this matter for awhile

oh, one more thing....not all inspections are hard and concrete.....some are very very very soft (eg monitoring behaviour).....there is no way of re-verifying the inspection results (another headache topic)....don't tell me....i know it sounds crazy but that is how it is


Looking forward to your comments and/or examples.

 

[Sidney Vianna]

From what I understand in your post, this organization could institute CA in case their SERVICE is faulty, eg, they approved a product that should have been rejected according to their customers procedures or vice versa. The CA would apply to them, not the customers.

 

[RoxaneB]

You could always take CA/PA based upon the results of your metrics/indicators (assuming you them). What about actions taken when a Customer complains? What about actions to be taken to avoid potential internal nonconformities?

 

[JRKH]

What procedures do you have in place and how can they go wrong

You may need to expand your thinking a bit.
You use your customers instructions to check parts. OK that takes care of only one aspect. There are still a lot of things that can go wrong. How do you receive parts? What if a part is damaged whille in your care? How are tools calibrated. verified? Are there environmental issues (heat and humidity) that must be monitored?

My point is that there are a lot of things that can go wrong within your system. There are a lot of processes that are not related to the actual inspections. This is where your CA/PA will apply.

James

 

[qualeety]

ok....additional info....and i bet this sounds crazy but it is very real

the inspection results are never questioned by the customers....YES THE COMPANY HAS IT GOOD!!!!......any defectives or non-conforming parts are handled by the customers.....the company has no liabilities....all parts/tools are borrowed from the customers at the time of inspection......so calibration is not an issue....this is clearly stated in the work instructions....there were no complains from the customers for last 4 yrs.....regardless of the inspection results: good or bad.....except one occasion where the inspection results were soooooooooo bad, customers actually changed the acceptance criteria......which the company adopted....the actual inspection method stayed the same but the acceptance standard has changed....now customers are happy since they are getting better results.....(yah, yah.. i had to threw up when i saw that but CUSTOMERS ARE ALWAYS RIGHT!!!!! as long as they don't violate any legal obligations).... the performance indicators are based on the number of inspections performed as scheduled.......again this sounds crazy but the customers are very flexible on the schedule and allow the company to do whenever it wants to do the inspections....(i know i know....but don't go there please)....only hick-up in the process is.....when there is a new inspection to be performed...but this is addressed in the clause 7.3 of the ISO9001...

sydney....your suggestion does not apply as explained above.sigh

james...thanks for you info but your examples does not apply to this case :truce: .... can you suggest any other examples

roxanne... there are no internal non-comformities....all inspectors are trained and approved by the customers...


as you can tell.....am very frustrated.....i cannot think of any examples where things can go wrong...any failures are externally influenced....of 400 inspections performed, there was no single incident of "trouble/failure/mistakes"...i thought of the following examples but i am really stretching it.....and i don't want to create something for nothing.

inspection not done because customers not ready (i mean, is this really CA/PA?)...please note, the company arranges everything prior to inspection...no suprise visits by the company.....imho, this is a logistical problem, not ca/pa....(somewhat covered under the clause 8.2.1)

inspectors take initiative to fix the defectives........but this is no no.....a major customer dissatisfaction if inspectors did that...

inspectors not following the work instructions......but this is captured in the clauses 7.1.5 and 8.2.2

HELP Please!!!!!

 

[Cari Spears]

Doesn't anything go wrong internally that the people who run your place don't want to happen again - whether the customer cares or not?

If you come back and tell us your bosses don't care - I'll bang my head on my desk!!

 

[RoxaneB]

Cari's right...does everything always work perfectly in your place of employment?

any defectives or non-conforming parts are handled by the customers.....the company has no liabilities

Does this apply to in-coming or in-process parts? Either way, it's great that the Customer handles them, but do you track them? How do you tell the Customer about nonconforming product?

....all parts/tools are borrowed from the customers at the time of inspection

And what if a tool is damaged while on your property and while being used by one of your employees?

so calibration is not an issue....this is clearly stated in the work instructions

Whose WI's? I mean your Customer is also, by the sounds of it, a Supplier...CA/PA could apply to them. They may give you bad product/tools.

there were no complains from the customers for last 4 yrs

So how are you handling Customer Satisfaction, out of curiousity? How are you demonstrating steps to improve your service to them?

the performance indicators are based on the number of inspections performed as scheduled

Is this your only performance indicator? Actual vs. scheduled? What about results of inspections? What about tracking it by inspections - you may spot a trend here.

when there is a new inspection to be performed...but this is addressed in the clause 7.3 of the ISO9001...

And does the new inspection always go according to plan?

james...thanks for you info but your examples does not apply to this case :truce: .... can you suggest any other examples

roxanne... there are no internal non-comformities....all inspectors are trained and approved by the customers...

Why don't they apply? Cari basically said the same thing as James....focus on internal failures. Better yet, implement a CA/PA process that will benefit your company in other areas...financial, safety, etc.

inspection not done because customers not ready (i mean, is this really CA/PA?)

Why weren't they ready? Saying they weren't ready isn't really adequate root cause analysis. Was there a communication break-down? Was there a malfunction with a piece of receiving equipment?

inspectors take initiative to fix the defectives........but this is no no.....a major customer dissatisfaction if inspectors did that...

So, take the initiative on the process, not necessarily the product.

inspectors not following the work instructions......but this is captured in the clauses 7.1.5 and 8.2.2

Huh? Why do you say that and what is 7.1.5? I also fail to see how you attribute the failure to follow documentation under Internal Audits.

IA findings could be tied into a CA/PA system.

And again, you have not identified the root cause here. The failure to follow documentation is the situation. WHY is documentation not being followed?

 

[qualeety]

thanks for your wonderful replies.

BCB, thanks for your thoughtful insight....i appreciate very much and given many thoughts....but sadly, it still does not work for me.... i swear this one is the toughest one i ever faced....i mean, i can put something together for the sake of registration but i prefer not to do that....since there is no benefit to the company, if i did that....so, here are some of the thought regarding your insights...please don't take it wrong....i am trying to explain it....just that am totally frustrated...

Cari's right...does everything always work perfectly in your place of employment?



Does this apply to in-coming or in-process parts? Either way, it's great that the Customer handles them, but do you track them? How do you tell the Customer about nonconforming product?

there is no need for the company to track the non-conforming parts (not required by the customers and no benefit to the companies to track the performance of customer's products....although this could be a continual improvement for the company, it does not fit into CA/PA)....the company inspects in-coming, in-process and finished parts (as demanded by the customers).....the inspection reports contains all the results, needed by the customers

And what if a tool is damaged while on your property and while being used by one of your employees?

the company does all the work in the customer's property.....if a tool is questionable (a judgement call by an inspector) while being used, an inspector will borrow another tool from the customers...this is addressed in the company's work instruction...for last 4 yrs, this never happened....btw, the company does not use delicate instruments such as vernier or micrometer or any other fine gages... a typical insturction would be a heavy duty torgue wrench (15lb+) with go/no-go setting....the customer takes care of any defectives found by the company.....from CA/PA view, there is not much, unless you take the "questionable gage" out of the work instruction and put it in CA/PA procedure....but it does not do anything but add paperwork.

Whose WI's? I mean your Customer is also, by the sounds of it, a Supplier...CA/PA could apply to them. They may give you bad product/tools.

see above....if bad tools are given by the customers, the company still uses the tool (unknowingly) and issues the report....since the company borrows the tool from the customers and customers never questions the inspection results, CA/PA does not apply to the comany .... i know it sucks but that is how it is...sigh.

So how are you handling Customer Satisfaction, out of curiousity? How are you demonstrating steps to improve your service to them?

an interesting question.....the customer satisfactions are measured by the increasing number of inspection requests....every year, the number of inspection requests increased....also, there a general meeting with the customers once a year.... this is addressed in the quality manual....clause 8.2.1 - customer satisfaction of ISO9001


Is this your only performance indicator? Actual vs. scheduled? What about results of inspections? What about tracking it by inspections - you may spot a trend here.

if any, the results of inspections are addressed by the customers with ZERO input from the company (other than the insepction reports)....this is mandated by the customers....all inspectors have been instructed to do the assigned work only....nothing more...there are many peformance indicators but number of inspections performed vs schedule is the only one.


And does the new inspection always go according to plan?

the biggest company's headache stems from new inspections....once approved by the customers, all new inspections go well according to the written instructions....getting approval is the hardest part...yah, i can see you or ....but for last 4 yrs, there was zero occurence of things going wrong with the new inspections by the company....also, the company has a generic inspection FMEA as a part of quality planning....(if i am desparate, i might use FMEA as CA/PA)

Why don't they apply? Cari basically said the same thing as James....focus on internal failures. Better yet, implement a CA/PA process that will benefit your company in other areas...financial, safety, etc.

for safety, the company has a system safety plan program...the company has ca/pa for safety (eg PPE) ...remember, i want to benefit the company but also i want the company to be iso9001 registered....am not going include things that are unncessary for iso9001...and if i recall safey/finance are not mandated in iso9001 unless one includes them.

Why weren't they ready? Saying they weren't ready isn't really adequate root cause analysis. Was there a communication break-down? Was there a malfunction with a piece of receiving equipment?

Regardless what are the reasons behind the cancellation, it is the beyond the control of the company.....one cannot create CA/PA for something one has no influence...yes, i sound defensive but what customer wants, customer gets....(am still puzzled over your suggestion...how i can use this as a part of CA/PA)

So, take the initiative on the process, not necessarily the product.

the company only does inspection....nothing more...all inspection processes have been approved by the customers and cannot be deviated without the customer approval...so the company's hands are tied more or less.....am sure inspectors can take a proactive approach and make the process better but this action will cause a major customer dissatifaction....internally, the decision has been made: what customers want, customers get...there is very little creativity for the inspectors....other than how they allocate their time to complete the inspections.


Huh? Why do you say that and what is 7.1.5? I also fail to see how you attribute the failure to follow documentation under Internal Audits.

the management does audits (for lack of better words) to check up on inspectors....to ensure they are doing the tasks per work instructions....all audits are recorded for internal audit purpose...for last 4yrs, there were zero problems.......oops, my mistake...7.1.5 should be 7.5.1


IA findings could be tied into a CA/PA system.

And again, you have not identified the root cause here. The failure to follow documentation is the situation. WHY is documentation not being followed?

the company has excellent training programs and the moral of the workforce is good...btw, if i created an impression of workers not following procedures, i am sorry....i was just throwing ideas of "what if"

YES, THIS IS CRAZY...THERE ARE MANY THINGS THAT CAN AND DO GO WRONG. (eg safety)..BUT I CANNOT RELATED THEM TO QUALITY...MORE SPECIFICALLY TO ISO9001 REQUIREMENTS ...i will get off the soapbox now...this has been very therapeutic.....

anyhow, thanks for all your comments....and looking forwad to new comments (if any)...i guess i better bang my head my against the wall few more times.....if the time comes for the registration audit, i guess i have to wing it.....

 

[RoxaneB]

YES, THIS IS CRAZY...THERE ARE MANY THINGS THAT CAN AND DO GO WRONG. (eg safety)..BUT I CANNOT RELATED THEM TO QUALITY...MORE SPECIFICALLY TO ISO9001 REQUIREMENTS ...i will get off the soapbox now...this has been very therapeutic.....

anyhow, thanks for all your comments....and looking forwad to new comments (if any)...i guess i better bang my head my against the wall few more times.....if the time comes for the registration audit, i guess i have to wing it.....

Quality? ISO 9001? Apply Continual Improvement to the everything, not just Quality! Think outside of (and off of) the soapbox! ISO 9001 is flexible enough to apply to more than just the product! Read ISO 9004.

 

[Cari Spears]

Have you ever had a nonconformance found as the result of an internal audit? Are internal audits being conducted yet?

I see from your profile that you're a QA Engineer in the Safety Dept of a 10,000+ organization. Are you the Management Rep or the one charged with implementation? Which standard is your organization trying to become registered to?