My company is certified ISO but they are not willing to spend money in calibration/preventive maintenance, calibration/PM activities of most equipmemnt are overdue, some of them has not been calibrated when received, how do I avoid the n/c from auditor?

Thanks

Hi
since im mechanical engineer i can tell you that PM is scheduled to save money to to waste money!!! as you say , I dont know from where you get this idea?
PM:

the extent of PM schedule depends on the company itself ,you can reschedule or limit yr PM- if it costly-, but make sure that this will not affect the quality of yr product on the long run .

calibtation;
the thing you can do here is to have inhouse calibration , that means that you will make the calibation by yr self , but surely depending on defined standards- like standards lengths or weights - and standard procedure

this is all according to the nature of yr work , consequently ,you cant omit the PM and calibration activities from yr quallity system

samer

Welcome to the Cove :bigwave: My company is certified ISO but they are not willing to spend money in calibration/preventive maintenance, calibration/PM activities of most equipmemnt are overdue, some of them has not been calibrated when received, how do I avoid the n/c from auditor?Unless the calibration gets done and the cause for the current situation is corrected, I don't see how you could possibly avoid getting dinged by the registrar. Nor should you...

If you have done your level best to inform those in charge about the problem (and do not forget to do so in writing, in order to protect your own bottom), such a n/c could be just what you need to get things back on track. Just make sure you avoid saying "I told you so" when it happens. Very destructive sentence, that one...

/Claes

I work for a small company that is ISO certified as well and have had the same problems what we did as a group was to evaluate what really needed to be calibrated in our company i.e. equipment used to test prototypes (we're a development firm). I would suggest tackling this with your manufacturing team and see if you can come to solution.

Best of luck,

Al

Klluk,
As Claes mentioned, inform those in charge of the situation. Has this issue been picked up during an internal audit? During an internal audit an NC should be issued if indeed these activities are not taking place no matter what the reason. Being already ISO certified, let the system drive your corrective actions.

Phil

If you have done your level best to inform those in charge about the problem (and do not forget to do so in writing, in order to protect your own bottom),Exactly - send out emails or something - but don't sound like the sky is falling - just let them know that you do expect to receive a nonconformance at your next surveillance audit. You could also mention the risks to product quality.

such a n/c could be just what you need to get things back on track. Just make sure you avoid saying "I told you so" when it happens. Very destructive sentence, that one...So true!:yes:

what we did as a group was to evaluate what really needed to be calibrated in our company i.e. equipment used to test prototypes (we're a development firm). I would suggest tackling this with your manufacturing team and see if you can come to solution.
Good idea, Allen.

klluk - Is your equipment calibrated in-house? Is it all sent out? Do you have a lot of equipment requiring calibration? Are there employee owned equipment - company owned - both?

When you approach management about this - can you offer up some possible ways to make it less costly and/or time consuming?

This is an example of the classic trade off between prevention and appraisal costs versus internal and external error costs. Although sometimes difficult, if the problem at hand can be expressed to upper management in these terms, costs, there will be a greater chance of success.

So, what would the cost be if your customer recieved bad product and (gasp) used it in their product before realizing the error? Or, say a critical piece of equipment breaks down, at a really bad time, due to lack of PM, and you miss a shipping deadline, shutting down your biggest customer. How much would that cost?

I would say that for many companies, the combined costs of just one instance of each of these snafus compared to the combined proposed maintenance and calibration costs would clairify things in an otherwise cloudy managerial environment. Show me the money.

My company is certified ISO but they are not willing to spend money in calibration/preventive maintenance, calibration/PM activities of most equipmemnt are overdue, some of them has not been calibrated when received, how do I avoid the n/c from auditor?

Thanks

Short answer, you can't and shouldn't.

I get to be the voice of doom and so forth here, but read the whole post first.....

PM:

Depending on your equipment, may be a nice thing to do or more likely is critical.....if PM is not done, do not expect machines to work well or turn out good product.....after all, what happens if you run your car for 15K miles without changing the oil?

CALIBRATION:

Calibration - done properly by professionals - is not cheap. Deal with it. Again, to your car, do you want Joe's Gas Station/Pizzeria/Calibration Lab doing your work, or take it to the dealer so it is handled by trained and qualified professionals?

You are in a no-win situation.....you need PM and cal done right, some folks do not want to spend money for that, and you get the CAR for it.....so here is what I would do for long term.....

Put together the numbers showing the cost of proper PM and having an accredited lab do your cal.....and the cost of repairs and recalls from bad product and broken/way out of spec machines.....give that to management.

Let's get real, managament is paid to look at the bottom line and make good things happen there.....if they are convinced that spending the money will do that, they will spend it.

Hope this helps.

Hershal

klluk: It is natural to want cost effective calibration. I suggest a look in the old thread Monitoring and Measurement - Small shop making tooling for the foundry industry (http://elsmar.com/Forums/showthread.php?t=6692), where another poster was concerned about the same thing.

/Claes

Where exactly does the standard say you must perform PM?

Where exactly does the standard say you must perform PM?6.3 is usually interpreted to require PM.6.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product
requirements. Infrastructure includes, as applicable
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport or communication).

6.3 is usually interpreted to require PM.
Yes, but the key word is interpreted. TS specifically calls for PM. ISO leaves you to define what you need. I do not think that you can actual get a NC for no PM.
Of course calibration is a different matter

Yes, but the key word is interpreted. TS specifically calls for PM. ISO leaves you to define what you need. I do not think that you can actual get a NC for no PM.
Of course calibration is a different matterI checked the TC176 web site for interpretation of 6.3 (http://www.tc176.org/pdf/rfi003_final6_3.pdf). If there are no records, then it didn't happen. If records aren't required, then you don't have to do it. How do you like my logic?

In addition to all previous posts of good advice and input, I would stress the following to management:

Weigh the cost of saving $$$ now vs. loss of $$$$$$ in the event of a MAJOR product recall or a potential MAJOR nonconformance from your Registrar's Auditor.

I noticed in your public profile that you are a Quality Engineer. Work the numbers, advise and hope to influence management.

Best wishes, and welcome to the Cove.:agree:

You can start with a review of the program to re-evaluate the procedure's fit to your needs. Change the procedure if you think it's appropriate. Then,

a) you can do an internal audit of the calibration process and give yourself a whopping major nonconformance, complete with a corrective action plan. Or,

b) you can let the registrar find the issue and he/she make the finding.

In either case the question may arise of why the problem wasn't noted sooner and acted upon. A few different elements may come into painful illumination, such as: how you plan to notify customers if you discover your product has been discrepant from this problem; how the problem has gone on this long: where was internal audit and management review?

This is a bad problem, sorry. :nope:

In addition to all previous posts of good advice and input, I would stress the following to management:

Weigh the cost of saving $$$ now vs. loss of $$$$$$ in the event of a MAJOR product recall or a potential MAJOR nonconformance from your Registrar's Auditor.

I noticed in your public profile that you are a Quality Engineer. Work the numbers, advise and hope to influence management.

Best wishes, and welcome to the Cove.:agree:I have attached a calculator for measuring quaity costs in this thread:
http://elsmar.com/Forums/showthread.php?t=13438&page=2

I checked the TC176 web site for interpretation of 6.3 (http://www.tc176.org/pdf/rfi003_final6_3.pdf). If there are no records, then it didn't happen. If records aren't required, then you don't have to do it. How do you like my logic?
:topic:
Very neat, just make sure you do not define other records in your procedures.
4.2.4 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system
Despite the fact that only in certain places are records required does not the above mean that in fact there should be records for every shall. The interpretation says no despite
The organization shall determine, provide and maintain the infrastructure