Customer Requirements - Deviate or Not? Medical Instruments for the orthopedics

[Katydid]

We are working toward ISO9001:2000 Rev registration in September of this year (already scheduled). I have been running into repetitive issues with Engineering, Quality, and Manufacturing. We are a machine shop that makes Medical Instruments for the orthopaedics industry. All product machined is produced to the customer drawings and specifications.

Here is the problem, our customers are so large that requesting a deviation or a change to a drawing can take up to two years. Previously the company has not been running to the ISO standard so it was standard practice for upper management to determine if the dimension in question truly affects fit, form, or function, and will deviate internally only. We have only one customer that has already given us a "blanket" approval of this process. We have not had success getting this information documented so it is valid, or getting our other customers to approve this practice, but they also do not want to be bogged down with frequent requests for deviation or changes to their drawings.

The biggest issue is that 10 to 15 percent of our product has one or more dimensions that are run outside of customer requirements, and the customer is uncooperative to change these requirements. With the upcoming registration audit in September, we need to find a way for us to satisfy our customers with timely delivery, a quality product, and limiting the customer contact to issues affecting fit form or function.

I need suggestions on effective ways to handle this type of customer base. Do you have any ideas?

Thanks!

 

[ralphsulser]

If your customers won't give you an official deviation and print revision, how about a signed waiver for X dimensions ofr X amount of time or pieces. Or a signed, dated print showing the allowable deviations.

 

[mshell]

We have the same situation here. I have started a specification review and we are in the process of identifying dimensions that do not meet the customer print. If the dimensions are identified as reference only on the print, we approve the deviation internally, modify the specification and reference the deviation # on the spec. If they are critical dimensions, we send the deviation to the customer for approval prior to modification of the spec.

You might want to try listing ALL deviations for each part per customer in one document (e-mail, fax, letter) and obtaining approval. You could then complete a deviation for each part # and attach a copy of the customer approval to each one. This would reduce the amount of paperwork for the customer and might speed up the process.

 

[Katydid]

mshell & ralphsulser, Both of your examples define what I want to do, but also is exactly what our customers drag their feet about while still demanding on-time delivery without concession. In my world, the least amount of work would be a "blanket" approval of our authority to determine fit form or function in house based on our review, but of course they don't want to approve that and loose their "control". I am hoping that someone out there has found a way to justify our reviews and approvals by default if customers are slow to respond. I'm just not sure how, or if it is even possible!

 

[mshell]

We have a similiar issue with First Article approvals. We are going to add a statement to our FA letter that says

"Failure to reject this request for approval within 10 business days will indicate approval of First Article parts."

I don't know if that would work for deviations. Maybe some of the experts can offer feedback.

 

[Caster]

...I am hoping that someone out there has found a way to justify our reviews and approvals by default if customers are slow to respond. I'm just not sure how, or if it is even possible!

[font=Times New (W1)]<O</O[/font]

[font=Times New (W1)]Ah, it sounds like a case of tight specifications loosely enforced!<O></O>[/font]


[font=Times New (W1)]I assume that these parts actually work in the end product? So the problem is with the specs and not the part?[/font]

[font=Times New (W1)]<O</O[/font]

[font=Times New (W1)]What we did in this case was to create a list of deviated specs as suggested. We had our plant manager, engineering manager, and quality manager sign off on it. [/font]

[font=Times New (W1)]<O</O[/font]

[font=Times New (W1)]We sent this to the customer informing them that we were going to run (and ship) to these specs and requesting their approval. We followed up every month. All this was shown to the registrar and was accepted as due diligence in our case.<O></O>[/font]

[font=Times New (W1)]<O</O[/font]

[font=Times New (W1)]Everyone was happy with this, but I made them go the extra mile for prevention. All of our new quotes contained a clause that stated "we will not meet these specs and will use these instead". Remember Contract Review is your friend if used correctly.<O></O>[/font]

[font=Times New (W1)]<O</O[/font]

[font=Times New (W1)]Eventually our customers engineers, buyers, and quality folks got tired of it all, and we all sat down and developed a mutually agreed set of specs. Interestingly, these were our specs and this raised a serious competitive barrier for our competitors. Another win thanks to ISO/QS.[/font]

[font=Times New (W1)]<O</O[/font]

[font=Times New (W1)]We found at this meeting that our customer designers were really good people, and were just as overworked as we were, and that their systems got in the way of doing the right things. We offered to make the drawing changes for them. Strong and lasting relationships were developed that day. This was called the million dollar meeting.<O></O>[/font]

[font=Times New (W1)]<O</O[/font]

[font=Times New (W1)]Sadly, this all took about 4 years, so my advice is start today.[/font]


[font=Times New (W1)]Good luck, never give up![/font]

 

[Bev D]

I have a similar situation, except that I am a prime to aircraft engine manufacturers, so deviating form the drawing without permission is not acceptable. For some medical applications this also the case. With aircraft engines the original designer is often gone...and the new guy has no idea why a requrrement was there, so they take the old "if it ain't broke, don't fix it" approach to changes and deviations.

There are always 2 issues involved: either our current tooling or process is no longer capable of meeting the blueprint (our problem to solve, really) or the drawing is not correct - it's requirements cannot be met. We utilize the quote and PO review period to notify our customer of the specification problems. Then of course we withold shipment until we get the official approval/change from them. If parts don't conform we don't ship.

Becuase we work closely with our Customers, supply them with plenty of 'up-front' warning and provide extensive data and/or analyses to back up our requests we have built a cooperative relationship (this takes TIME and persistance) that works for us. But even then, it can takes months to get the approvals and then usually at the bottom of the 13th inning...'

Just do the right thing over and over and over and eventually you'll get there...sorry but for this there is no magic bullet except postiive persistance...

However, I might advise against shipping nonconforming material that he customer hasnt' officially apporved, legally this probably puts you in violation of your contract and can make you liable for any damage doen if your parts are determiend to be the cause...also, I wouldn't think that this approach woudl be acceptable to a 3rd party auditor...

 

[Wes Bucey]

We are working toward ISO9001:2000 Rev registration in September of this year (already scheduled). I have been running into repetitive issues with Engineering, Quality, and Manufacturing. We are a machine shop that makes Medical Instruments for the orthopaedics industry. All product machined is produced to the customer drawings and specifications.

Here is the problem, our customers are so large that requesting a deviation or a change to a drawing can take up to two years. Previously the company has not been running to the ISO standard so it was standard practice for upper management to determine if the dimension in question truly affects fit, form, or function, and will deviate internally only. We have only one customer that has already given us a "blanket" approval of this process. We have not had success getting this information documented so it is valid, or getting our other customers to approve this practice, but they also do not want to be bogged down with frequent requests for deviation or changes to their drawings.

The biggest issue is that 10 to 15 percent of our product has one or more dimensions that are run outside of customer requirements, and the customer is uncooperative to change these requirements. With the upcoming registration audit in September, we need to find a way for us to satisfy our customers with timely delivery, a quality product, and limiting the customer contact to issues affecting fit form or function.

I need suggestions on effective ways to handle this type of customer base. Do you have any ideas?

Thanks!

This scenario is a typical example of the "what if" type of questions which appear in Quality Manager tests.

Some of the workarounds suggested may work for a short run, but to :ca: , you need to have your top management "jawbone" with the powers that be at the customer, to arrive at a mutually agreeable resolution which will survive the "memory" of the receiving inspection team which currently accepts material which is nonconforming to the print.

This means WRITTEN DOCUMENTATION of the agreement.

Sometimes, it can be as simple as a memo signed by officials from customer and supplier, which explains the situation and declares that material which meets the "expanded tolerances" will be accepted, since it meets "functional" requirements.

In other cases, depending on the customer, it may be necessary to FORCE an Engineering Change Order at the customer through in expedited fashion to incorporate the changes into the approved design.

Don't jump at any solution until both customer and supplier have had a chance to discuss this at a level where the players have ink in their pens to implement the agreement. (low level Quality geeks don't have ANY ink in their pens)

I want to thank you for this topic, because it illustrates one of the issues of Configuration Management for the paper I'm working on.

 

[Claes Gefvenberg]

Good thread

Here is the problem, our customers are so large that requesting a deviation or a change to a drawing can take up to two years.

What on earth??? Somehow, I don't think the company size is to blame for that. What I rather do wonder is how an organisation that rigid can stay in business?

Some of the workarounds suggested may work for a short run, but to :ca: , you need to have your top management "jawbone" with the powers that be at the customer, to arrive at a mutually agreeable resolution which will survive the "memory" of the receiving inspection team which currently accepts material which is nonconforming to the print.

This means WRITTEN DOCUMENTATION of the agreement.

And there we have it, Katy.

As Wes correctly points out, the problem is not your looming registration audit but something much more down to earth: You currently ship products that are out of spec, and that may be (unofficialy) ok today. It is a fair bet however, that some day the customer will decide that it is not, and that is when you may find yourself in a heap of trouble. You are quite right to attack this state of affairs.

/Claes

 

[Katydid]

As Wes correctly points out, the problem is not your looming registration audit but something much more down to earth: You currently ship products that are out of spec, and that may be (unofficialy) ok today. It is a fair bet however, that some day the customer will decide that it is not, and that is when you may find yourself in a heap of trouble. You are quite right to attack this state of affairs.
/Claes

Thanks Claes. I have only been with the company for 2 months, and this will be my first "big" battle. I appreciate the support and affirmation that I am going down the right path on this one. I'll let you know the result of my quest one of these days. It may take a while to acheive the shift in perspective around here, but I feel up to the challenge.

"Life is trouble, only death is not. To be alive is to undo your belt and look for trouble."- Kazantzakis