Dear Mr

we do a heat treatment for metal to increase the hardness of metal

we do it under the good condition


after finish the process we mesure the hardness of metal


is this a special process or not ?
7.5.3

Yes, it is.

(plating and coating are also special processes)

Yes, heat treating is a special process. Special processes are under 7.5.2 (not 7.5.3 which is traceability).

You need to validate the process, which it sounds like you may be doing. If you are following a specification (recipe, such as an ANSI or MIL Specification), monitoring the process (oven temps and time) and checking what you can (hardness test) that looks like validation to me. You should be retaining the results of monitoring (oven log and test results) as evidence of validation.

is this a special process or not ?The answer is: It depends. Is the heat treatment done solely for hardening the part? Is the hardening of the metal localized to a specific area of the part? Can you effectively measure the hardness of the area without inducing unacceptable denting onto the part?

If you can answer these 3 questions as "yes", then, this is not a process that needs to be validated since you can effectively "inspect" the characteristics at the end of the process, against the requirements.

It's not a special process if your buisness is the heat treating of metal.

And as has already been said, it depends.

By the way, what does heat treating of metal have to do with shrimp, milk, cheese and other things?

It's not a special process if your buisness is the heat treating of metal.

And as has already been said, it depends.

By the way, what does heat treating of metal have to do with shrimp, milk, cheese and other things?

and garage doors.........

Sydney and Randy have quite rightly mentioned conditions under which the heat treatment may not be called a special process. However if you have a number of identical parts in the heat treatment batch and are accepting the batch by checking only a sample for hardness, then it would be special process. You would need to specifiy and maintain the process parameters - Temp range and time of exposure - besides the hardness check of the sample.

The answer is: It depends. Is the heat treatment done solely for hardening the part? Is the hardening of the metal localized to a specific area of the part? Can you effectively measure the hardness of the area without inducing unacceptable denting onto the part?

If you can answer these 3 questions as "yes", then, this is not a process that needs to be validated since you can effectively "inspect" the characteristics at the end of the process, against the requirements.

Good point. You are right, it depends.

Something to remember is that heat treat can be a very complex subject. What happens inside the metal really cannot be fully analized short of sawing the part for a look inside to see the molucular changes and grain structure changes.

If you are depending on such internal changes, something that you cannot tell from any external check, then it is a special process and you need to show how you are validating it.

i think it is not special process because we have a device to measure the Hardness of metal

we also manfacturing of die

where we produce one upon the requirement of customer then we send it to the customer for trial

and if he accept then it will be approved

is this indicate for any special process


where we can't validate the die untill the customer received it and try

Is this the same place with the cheese on rusty racks and the sewer pipe?

i think it is not special process because we have a device to measure the Hardness of metal

Is hardness the only characteristic you care about, or is hardness used to confirm that the heat treat has progressed to the point you want?

Depending on what you are after, hardness could be part of your validation or it might be your ability to fully test the outcome.

You really need to be able to answer the question "does hardness tell us all we need to know?"

The heat treat shops I call on check hardness, but they also keep meticulous records about oven temperatures and times during the heat treat process. In their case, hardness is not enough.

i think it is not special process because we have a device to measure the Hardness of metal

Do you measure 100% of the parts?
What is your process capability?
Is the hardness check destructive to the part?
Is hardness the only criteria? (what about through hardening, micro/macro structure?
What is your customer requirement?

I think it is unless it can be proven otherwise?

Do you measure 100% of the parts?
What is your process capability?
Is the hardness check destructive to the part?
Is hardness the only criteria? (what about through hardening, micro/macro structure?
What is your customer requirement?

I think it is unless it can be proven otherwise?

Plus, an indentor check isn't a check of homogeneity of the hardness throughout the part.....

No, it is a special process and requires validation.....
(unless you're checking the hardness of dairy products......)

No, it is a special process and requires validation.....As in the Welding - Is welding always a special process per ISO9001:2000 Clause 7.5.2 (http://elsmar.com/Forums/showthread.php?t=20822&highlight=welding+special+process%3F) thread, my conclusion is that all encompassing generalizations bring a degree of risk.

As in the Welding - Is welding always a special process per ISO9001:2000 Clause 7.5.2 (http://elsmar.com/Forums/showthread.php?t=20822&highlight=welding+special+process%3F) thread, my conclusion is that all encompassing generalizations bring a degree of risk.

Well yes Sidney, however, once again, since we're only given a general question, we can only reasonably answer in general terms, lest we confuse the issue with all the caveats..........and what use is that for 90+% of the cases we're presented with.

There is an inherent risk with anything you read here. Who knows anything about the background competencies, knowledge etc. of anyone offering advice?

Well yes Sidney, however, once again, since we're only given a general question, we can only reasonably answer in general terms, lest we confuse the issue with all the caveats..........and what use is that for 90+% of the cases we're presented with.?In another post, you were concerned with someone potentially misleading readers here.

If someone asks Is Heat treatment for metal a special process?the only possible answer is: Not always/It depends.

To state that heat treating is ALWAYS a special process that requires validation would be misleading, in my opinion.

I beg to differ. Heat treatment is a classical example of a special process.

In another post, you were concerned with someone potentially misleading readers here.

If someone asks the only possible answer is: Not always/It depends.

To state that heat treating is ALWAYS a special process that requires validation would be misleading, in my opinion.

So, I will have to disagree with you. Heat treatment in my experience - not opinion - has always been something that cannot be checked - adequately - after the product has been processed! Ask anyone who has ever cooked something......

I beg to differ. Heat treatment is a classical example of a special process.

Why?

What makes it special?

What is the definition of special as it relates to an ISO based QMS?

Heat treatment is a classical example of a special process.Heat treatment in my experience - not opinion - has always been something that cannot be checked - adequately - after the product has been processed!So, why is it that ISO 9001 leaves it open and does not have a statement to the fact that


7.5.2 Validation of processes for production and service provision
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.

Heat treatment and welding are ALWAYS special processes that need to be validated.
If what you say is incontestable, wouldn't it be much easier for the TC 176 to list all the processes that MUST be validated? :tg:

So, why is it that ISO 9001 leaves it open and does not have a statement to the fact that

If what you say is incontestable, wouldn't it be much easier for the TC 176 to list all the processes that MUST be validated? :tg:

Not if it takes them 8 years to do a revison...they'd always be behind technology advances.........:lol:

Maybe there ought to be some validation of TC176 done as part of the whole process:lol:

That was a good one regarding reference to TC 176 and quite lively discussion too including the 'free advice' that is given by some of us.To take away the 'heat' from the Heat Treatment - if I may say so - here is a quote (source: anonymus)

"If you are wise, take this advice: Never give advice."

Jupitor

Its a very healthy and lively discussion on the subject, and experts have covered all the views- for & against -in granting 'Heat treatment' a special process.

I would like to focus attention on the relevant clause:

3.4.1 Process NOTE 3 - A process where the conformity (3.6.1) of the resulting product (3.4.2) can not be readily or economically verified is frequently referred to as a "special process".

Since a heat-treated product can not be readily or economically verified, that it has achieved the desired result after the process, IMO it falls under the category of a "Special Process"; and needs validation under 7.5.2.

Umang :D

i think it is not special process because we have a device to measure the Hardness of metal


Determining the Rockwell or Brinell hardness number from a heat treated sample would not be able to tell you whether this requires validation or not IMHO.This may come under 8.2.4 - measuring and monitoring of product, that too the result would be a general result and for the whole batch sent for heat treatment in the furnace.

In My opinion for a clear understanding you may stick to the "recipie" concept, if there is a defined recipie for something it needs to be validated for adequacy from time to time, this is also true that if you are able to do a 100% inspection without causing any kind of damage to the product then you can do away with clause 7.5.2.

The heat treatment depends on a lot of things like heating time, heating temeperature, type of material , no. of batches in operation whether normalization is required or not...etc. But it is worth mentioning that 7.5.2 talks about validation of the "PROCESS" (of heat treatment),not the "PRODUCT" (output of the heat treatment process).

Regards,

Arin

Define....can not be readily or economically verified

If you supply automotive, HT is special, and even has its own special process audit.

https://www.aiag.org/source/Orders/index.cfm?mystartrow=11&realstartrow=21&section=orders&activesection=AiagPubs&task=0&search=S (https://www.aiag.org/source/Orders/index.cfm?mystartrow=11&realstartrow=21&section=orders&activesection=AiagPubs&task=0&search=S)


If you supply me, I would want to know that you control your HT process, not just do a few hardness tests.

Every time I see spacial processes, I hear Dana Carvey on SNL as the Church Lady!

"Now isn't that special!"

http://www.geocities.com/Hollywood/Agency/5280/DanaCarvey.html (http://www.geocities.com/Hollywood/Agency/5280/DanaCarvey.html)

i think it is not special process because we have a device to measure the Hardness of metal
Dear Tech.
I think your ability to measure hardness is in a way giving you the confidence to say it is not special. However as said in one of the thread here, heat treatment is a very complex process and the desired results can be achieved only in the controlled conditions necessary for the desired result.
I have this list for you to think and make a judgement about it :
1. How big is the heat treatment furnace ?
2. Are you able to get the same range of temperature at all zones of the furnace ?
3. What is the load everytime to the furnace ? Is it same or it varies ?
4. Do you measure the hardness of parts heat treated from all zones of the furnace each time ?
Hardness measurement capability that you have is one of the required measure to assess that the set parameter for the heat treatment process is good. It helps you to validate and revalidate the heat treatment process as and when charge batch changes or a maintenance schedule on the furnace is executed or any such repairs are done to the furnace. Hence on a larger look you have to notice that you have ability to validate the heat treatment process and that is the requirement.
Hence with just the ability to measure hardness, do not dilute the requirment of validation of this very critical metal process. It needs validation and constant revalidation as you go along.
I hope you are able to appreciate the requirement my friend .... good luck

I think some people are showing they have a hard time, thinking out of their boxes. Specially in auditing, this is a very bad trait. ISO 19011 reminds us that auditors must be open minded.

Imagine that I design and install automated gates. One of my sliding gates (see example below) rolls back and forth on a metal rail. My years of experience tell me that, when dealing with heavy gates such as this, there is a lot of wear on the parts of the rail that are in contact with the metal rollers. So, I decide to improve the product by hardening that surface on the rail and I have established a hardness requirement, based on my experience. I use a simple MAPP (methacetylene propadine) gas torch to harden the metal. I check the hardness of the metal surface with a properly calibrated hardness tester in 10 different spots, which provides me with confidence that the part will last for the projected life cycle of the gate. So, there you have it: a heat treating process that can be fully verified at the end. No validation required.

http://www.midlandgateautomation.co.uk/images/gate%20photos/Sliding5.jpg

Hey Sidney.don't hit people with "out of the box", that'll really mess 'em up:lol:

I kinda like "professionals" existing in their own induced state of Tunopia...it leavse more room for me to move around;)

With all due respect, this is not thinking out of the box, this is bending backwards to prove a personal opinion. Everything in your example are just opinions. May I ask how exactly you determine the required hardness "based on your experience"? How many rails have you designed and installed and monitored for years to arrive at the required hardness?
"I use a simple MAPP (methacetylene propadine) gas torch to harden the metal."
Well this is the exact opposite of professional metal hardening by heat treatment.
For your info the process is done in a furnace with controlled temperaure for a defined number of hours that is dependent on the steelyou start with and the hrdness you want to achieve (this is based on engineering tables , not on anyone's OPINION
With a hand burner the chances of getting the same hardness at 10 points along the rail is same as winning the lottery. And if I may ask , what do you do if you get 10 different hardness values ?.....
You give an example of a process that you perform as a non-process and then go on and state it doesn't need validation. I agree that the way you carry out the process it cannot be validated because a priori each rail hardened this way will have different values...

So, Sidney, how do you feel about the stress risers you introduced by hitting the part with an indentor? I fully agree with Mr. Grunfeld and his analysis of your post. And please, don't ever suggest that we have a hard time thinking out of the box.......simply because someone takes a contrary position to your own.....

For your info the process is done in a furnace with controlled temperaure for a defined number of hours that is dependent on the steelyou start with and the hrdness you want to achieve (this is based on engineering tables , not on anyone's OPINIONSomeone should tell the master sword-smiths making samurai swords for centuries that they need enclosed furnaces with calibrated thermocouples and the profile checked every 3 months or so and engineering tables to achieve the end result. And, golly, they better have records of those validation steps.

I've exhausted my argumentation. I think it is very useful that readers know very clearly where some of the covers (and possibly their employers) stand on this issue.

Someone should tell the master sword-smiths making samurai swords for centuries that they need enclosed furnaces with calibrated thermocouples and the profile checked every 3 months or so and engineering tables to achieve the end result. And, golly, they better have records of those validation steps.

If we are going there, how about Henry Ford's SPC charts and MSA's?

Someone should tell the master sword-smiths making samurai swords for centuries that they need enclosed furnaces with calibrated thermocouples and the profile checked every 3 months or so and engineering tables to achieve the end result. And, golly, they better have records of those validation steps.

I've exhausted my argumentation. I think it is very useful that readers know very clearly where some of the covers (and possibly their employers) stand on this issue.

The simple fact is that in modern manufacturing volumes, we don't have the luxury of waiting for 20 - 30 years before those chaps learned their trades..... I find it almost ridiculous that you'd compare an artisan's skills to production technology. The 'special process' requirements are there because we no longer have artisans.....

Oh, and in case any Covers need to know - like most of us and our employees we usually post in our personal - not professional - capacity just as you do Sidney!

The simple fact is that in modern manufacturing volumes, we don't have the luxury of waiting for 20 - 30 years before those chaps learned their trades..... I find it almost ridiculous that you'd compare an artisan's skills to production technology. The 'special process' requirements are there because we no longer have artisans.....The example I offered for my sliding gate project is an industrial application, albeit low volume. Since you agree with Mr. Grunfeld, you also agree that my example does not constitute a heat treating process, just because it is not done in enclosed, profile verified furnaces.

You keep limiting the discussion to modern manufacturing volume and the like. I don't. ISO 9001 was developed in a open, generic manner by design, so it would accommodate the specifics of the business at hand. There are many unconventional business that use ISO 9001 as a model for their quality management system. While in the majority of cases, heat treatment processes need to be validated, that does not apply in 100% of the cases. That is why the standard leaves it open; that is why we have to determine what are the requirements associated with the product and the process, before we assess if the process needs to be validated or not.

When it comes to ISO 9001 implementation, one size does not fit all.

I think it is extremelly important for us to remember that if I unecessarily impose a process validation requirement onto an organization, I am adding costs to their operation. We should not forget the financial implications of mandating steps which might not be required, nor value-adding, in terms of improving product performance or reliability.

the National Aerospace and Defense Contractors Accreditation Program (NADCAP) is an accreditation organization specializing in Special Processes; they definitely define heat treating as one of these. Just Google "NADCAP" if you want more info. They have a glossary of terms that you may fine helpful.

As mentioned by other folks posting here, it depends on how you are using the process, I suppose, but really it is not that hard to validate this process through work instructions, specifications (both of which you can obtain externally from various sources, including oven and hardness testing equipment manufacturers) and qualification of your operators.

The point I am trying to make is it is easier to validate this process than get in a discussion with your auditor on why you didn't. It is my experience that Heat Treating is assumed to be a Special Process by auditors, so just go ahead and validate it.

:)

the National Aerospace and Defense Contractors Accreditation Program (NADCAP) is an accreditation organization specializing in Special Processes; they definitely define heat treating as one of these. Just Google "NADCAP" if you want more info. They have a glossary of terms that you may fine helpful. Yes, I am very familiar with NADCAP and it's implications to aerospace & defense organizations as you can tell by this post (http://elsmar.com/Forums/showpost.php?p=246581&postcount=15). But not every organization out there is in the aerospace, automotive, nuclear, etc. supply chains. There are organizations that have an unsophisticated, non-critical product lines that still have to demonstrate compliance with ISO 9001. The point I am trying to make is it is easier to validate this process than get in a discussion with your auditor on why you didn't. It is my experience that Heat Treating is assumed to be a Special Process by auditors, so just go ahead and validate it.As someone who works for a certification body, I offer you a different opinion. Because true process validation will add cost to your organization. Accepting unjustified expectations by a third-party auditor is a sure fire way to end up with a dysfunctional quality system. Imagine, for example, if you have a curing process that requires the part to be in the oven at 250 degrees +/- 10, for 45 minutes. You tell the auditor that you use a log to record when the parts went in the oven and the wall clock tells you the elapsed time. If the auditor tells you that you have to calibrate the wall clock, would you accept it? :frust:

I didn't mean to imply that NADCAP was appropriate for the man who made the original post-just that their website was a good resource.

...still contend that the assumption is HT is a special process by most auditors and customers for that matter. It may be easier to go ahead and validate it as mentioned in my earlier post (work instructions, specifications, personnel qualification).:)

I am in 100% agreement with you that if a requirement is not applicable and complying will be expensive and non-value added then you should not do it. Exception of course is if it is a customer requirement. I saw a post here the other day which was very astute: "sometimes the only ROI (return on investment) is keeping the customer satisfied"

Someone should tell the master sword-smiths making samurai swords for centuries that they need enclosed furnaces with calibrated thermocouples and the profile checked every 3 months or so and engineering tables to achieve the end result. And, golly, they better have records of those validation steps.

I've exhausted my argumentation. I think it is very useful that readers know very clearly where some of the covers (and possibly their employers) stand on this issue.

Dear Sidney,

I understand that you have added a bit of :sarcasm: in your post and it is very relevant to think that the samurai sword smiths have achieved mastery in their production as far as the quality of the product is concerned.

But it is also for sure that while we talk about the mastery, we never talk about the rejections during the product realization process as the flip side. They used to prepare gem of a sword after may hits and trials.

Just let me share one more though with you, were there many competitors competing for a chunk of business??? Were there laid down specifications those days? IMO - no!!!!!

Just consider a modern age scenario where two weapon manufactures are supplying the same gun, one having a well validated process with less rejection and quality of product as conforming, and other having excellent product quality with more rejection figures due to lack of process conformity.....I would undoubtedly go with the first.

Regards,

Arin

As in the Welding - Is welding always a special process per ISO9001:2000 Clause 7.5.2 (http://elsmar.com/Forums/showthread.php?t=20822&highlight=welding+special+process%3F) thread, my conclusion is that all encompassing generalizations bring a degree of risk.

Any process where you cannot validate the end result without performing a destructive test is a special process. Welding and heat treating are included in this, no thinking outside of the box required.

I understand that you have added a bit of :sarcasm: in your post and it is very relevant to think that the samurai sword smiths have achieved mastery in their production as far as the quality of the product is concerned.You missed my point. According to Mr. Grunfeld, heat treatment only happens in modern, thermo-profile verified industrial ovens. My example of samurai swordsmithing was to show the fact that heat treatment of metals has been in existence for millennia, preceding modern equipment. Any process where you cannot validate the end result without performing a destructive test is a special process. Welding and heat treating are included in this, no thinking outside of the box required.The piece about destructive testing is your own addition to the definition of "special processes" and unsupported by the ISO 9001 standard. Many times, you can validate processes using non-destructive techniques. I've already offered (what I believe are) examples of a welding and heat treating process that do not need to be validated. You are obviously entitled to disagree, but let me offer you this: In the sliding gate scenario, the hardening of the rail would be a definitive product enhancement, minimizing the wear on the rail, increasing it's life cycle. Now, you come as an auditor, observe the fact that the gate maker is doing this heat treatment and demand the process be validated. The gate maker will have to develop a process specification, make samples, have samples destructive and non-destructive tested, etc., all non-value adding steps in order to comply with your interpretation of the standard. Or the gate maker might say: forget this non-sense. I will no longer heat treat the rail, which will make the product inferior, but the system will now be in compliance with the auditor's interpretation of what special processes are. A typical example of how ISO 9001 mis-implemented and mis-audited goes against the goal of improvement.

You missed my point. According to Mr. Grunfeld, heat treatment only happens in modern, thermo-profile verified industrial ovens. My example of samurai swordsmithing was to show the fact that heat treatment of metals has been in existence for millennia, preceding modern equipment. The piece about destructive testing is your own addition to the definition of "special processes" and unsupported by the ISO 9001 standard. Many times, you can validate processes using non-destructive techniques. I've already offered (what I believe are) examples of a welding and heat treating process that do not need to be validated. You are obviously entitled to disagree, but let me offer you this: In the sliding gate scenario, the hardening of the rail would be a definitive product enhancement, minimizing the wear on the rail, increasing it's life cycle. Now, you come as an auditor, observe the fact that the gate maker is doing this heat treatment and demand the process be validated. The gate maker will have to develop a process specification, make samples, have samples destructive and non-destructive tested, etc., all non-value adding steps in order to comply with your interpretation of the standard. Or the gate maker might say: forget this non-sense. I will no longer heat treat the rail, which will make the product inferior, but the system will now be in compliance with the auditor's interpretation of what special processes are. A typical example of how ISO 9001 mis-implemented and mis-audited goes against the goal of improvement.

In addition to all of this, there's an assumption that "heat treating" is limited to processes intended to harden metals. Where does this leave a process such as the baking used to prevent hydrogen embrittlement of electroplated parts? It's not unusual at all to see customer drawings that just say (as part of a plating spec) "Bake for [x amount of time] at 400 degrees F within one hour of plating." Doing what the specification says to do fulfills the requirement.

The need for destructive testing isn't, by itself, a criterion either. If I choose to accept the financial burden of destructive testing of a statistically valid sample of heat-treated parts, I've done "subsequent monitoring and measurement," haven't I?

Validation of a heat treating process relieves the organization of the need for destructive testing, and is presented as an option to destructive testing, not a mandate against it.

The need for destructive testing isn't, by itself, a criterion either. If I choose to accept the financial burden of destructive testing of a statistically valid sample of heat-treated parts, I've done "subsequent monitoring and measurement," haven't I?



I believe you have not. You cannot sell the parts you have destructively tested. You have not monitored and measured what you are selling and that is why validation is needed.

I believe you have not. You cannot sell the parts you have destructively tested. You have not monitored and measured what you are selling and that is why validation is needed.

So you're saying that a statistically valid sample doesn't represent the lot? If that's the case, how can I ever validate anything? Why would you accept the idea of a statistically valid sample of almost anything else, such as machined parts?

So you're saying that a statistically valid sample doesn't represent the lot? If that's the case, how can I ever validate anything? Why would you accept the idea of a statistically valid sample of almost anything else, such as machined parts?

I'm certainly not saying that.

I'm saying that you have not performed "subsequent monitoring and measuring". If you could, then you would not need to validate. Validation is not "subsequent monitoring and measuring".

A statistically valid sample that confirms the product can be used as intended CAN BE PART OF VALIDATION.

I'm certainly not saying that.

I'm saying that you have not performed "subsequent monitoring and measuring". If you could, then you would not need to validate. Validation is not "subsequent monitoring and measuring".

A statistically valid sample that confirms the product can be used as intended CAN BE PART OF VALIDATION.

Define "subsequent" in this context. Or more to the point, subsequent to what? I think it means "after manufacture," (which includes secondaries like heat treating) so if I do legitimate lot sampling subsequent to heat treating, how is it that I have not performed subsequent monitoring and measuring?

ETA: Whether or not heat treating is a special process depends wholly on the specifications.

ETA: Whether or not heat treating is a special process depends wholly on the specifications.http://www.ben-newman.de/smilie/signs/blasphemy.gif
Stone him....:lol:
R_hlMK7tCks

Define "subsequent" in this context. Or more to the point, subsequent to what? I think it means "after manufacture," (which includes secondaries like heat treating) so if I do legitimate lot sampling subsequent to heat treating, how is it that I have not performed subsequent monitoring and measuring?

ETA: Whether or not heat treating is a special process depends wholly on the specifications.

The context is right there in 7.5.2. No word-smithing will get around it. With your train of thought there would never be a need for validation of processes.

It IS a special process if you need to evaluate a characteristic that is changed by the process, but cannot be evaluated without some consumption of the product itself. If you have to use NDE (itself a special process) or a sample prepared by exposure to the process to perform the evaluation of the characteristic... then you have a special process. :cool:

Hmmmm

So you hardened the wear plate?

Perhaps the gate designer made the plate softer than the rollers because it would be easier, faster and cheaper to replace than the rollers?

Have we gone sideways on special processes? It means less than nothing IMO.

I always like to look beyond the words of the standard for the intent.

You need to control time and temperature to heat treat. Period.

Yes, you can measure some part properties after the fact, but if the process is off, it is too late and at best you may need to re heat treat, or at worst you may have made scrap.

Thus a thinking person would make sure that time and temperature we in control, making this into that scary, scary thing called a special process.

Don't even get me started on the art of blacksmithing or Damascus steel, or crystal skulls or ancient batteries, or pyramids made by UFOs, or any old ways were better bunk.

Indiana Jones showed us all how to deal with a sword!

Steel is steel, there are no magical properties in a Samurai sword.

The context is right there in 7.5.2. No word-smithing will get around it. With your train of thought there would never be a need for validation of processes.

No "word-smithing" is necessary, and my train of thought, though it might move slowly, is firmly on the tracks. Let me ask another question, since you avoided the one about the meaning of "subsequent," and didn't acknowledge that any destructive testing (monitoring and measuring) I choose to do will be "subsequent" to production.

Suppose you have a drawing with a specification that says, "Heat treat to x degrees (F) for y hours after machining." That's all she wrote. What do I check? How do I (and why should I) validate the process? Don't think for a minute that specs like that don't exist; I've seen 'em.

You can't say that validation of any process is necessary or required in all cases so long as a single case exists where it's obviously not necessary. And I gladly acknowledge that in the vast majority of cases, validation is necessary. But "vast majority" ≠ "100%."

No "word-smithing" is necessary, and my train of thought, though it might move slowly, is firmly on the tracks. Let me ask another question, since you avoided the one about the meaning of "subsequent," and didn't acknowledge that any destructive testing (monitoring and measuring) I choose to do will be "subsequent" to production.

Suppose you have a drawing with a specification that says, "Heat treat to x degrees (F) for y hours after machining." That's all she wrote. What do I check? How do I (and why should I) validate the process? Don't think for a minute that specs like that don't exist; I've seen 'em.

You can't say that validation of any process is necessary or required in allcases so long as a single case exists where it's obviously not necessary. And I gladly acknowledge that in the vast majority of cases, validation is necessary. but "vast majority" ≠ "100%."

I'm not going to break the sentence down for you. The context is clear.

Now getting back on track, you may remember that I agreed that in determining if something is a special process "it depends" so I'm not in the school that says there are hard fast rules on what is or is not a "special process". Perhaps better said is the hard and fast rule is as the standard states "The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered."

So the fact that monitoring or measuring took place is not enough when you still cannot for certain tell the outcome.

I know you know this stuff.

So the fact that monitoring or measuring took place is not enough when you still cannot for certain tell the outcome.

We work with uncertainty all the time. In fact I'll go so far as to say that there is almost no occasion ever when dealing with a large lot of products when we can "for certain tell the outcome" for all of the individuals. The best we can do in most cases is be able to predict with a reasonable amount of certainty how many bad ones there might be. Thus my point about statistically valid sampling plans--why are they considered OK for machining (e.g.) and not for heat treating? In both cases, conscientious process control will almost never account for every possible variable, and the best-laid plans will sometimes go astray.

I'm not against validation; in fact I think we should do more of it because validation is about understanding and controlling variation such that outcomes are reasonably predictable and risks are understood. The great irony to me is that customers, by and large, will accept the idea of validation without subsequent monitoring and measuring for heat treating (and other special processes) but not for non-special processes.

I know you know this stuff. There's some stuff I know, but there's more stuff to learn, and sometimes I learn it in these conversations. :agree1:

Suppose you have a drawing with a specification that says, "Heat treat to x degrees (F) for y hours after machining." That's all she wrote. What do I check? How do I (and why should I) validate the process? Don't think for a minute that specs like that don't exist; I've seen 'em. ."
I don't see anything wrong with that spec. All it requires that the piece be heat treated according to a specified recipe. Perhaps it's just for strain relief, or hydrogen de-embritlement or hardening without a specific Rockwell hardness required.
How and why should you validate?
First off, in previous posts you decribed validation as writing a spec,preparing samples, testing the samples, etc.- all implying that you have to validate your product and not the process.(The two shouldn't be mixed up. Validating your product that may or may not incorporate a heat treatment step in its manufacturing process is a totally different issue! )
In practice,companies don't do heat treatment in -house except if the volume justifies having a dedicated department for that. The usual case is that you go to a subcontractor that already has a heat trement process in place that is validated. Remember that the process has to be validated before you use that process on your part.(Likewise if it's in house the validation of the heat treatment process is done once ( ok ocassionally it needs re-verification) on typical parts used as vehicles for the validation of the process) so it's one time (or yearly) expense with just a negigible effect on the price of a specific product
How do you do that? simply , you visit the place, audit if their furnace has the necesary temperature range, control of temperature and time, that the instruments are calibrated and the operators are trained/certified. In addition you would also audit to verify that they have in place adequate material management control and records to ensure they don't mix up different batches of different clients.
I may have skiped a few points , but that's the general idea.
As opposed to what you implied in previous posts, one doesn't have to pay for that when you go to such a certified processor.
Once your parts have passed through a validated process as above,and receive the adequate paper work attesting to it, it's up to the specific application and criticality to decide how much subsequent testing and at what confidence (sampling plan) should be done on the parts.
And btw, I take your advice and next time I audit a samurai sword-smith shop for compliance to ISO9001, I'll consider skipping the validation of the steel hardening provided he can show me that he's finishd his 20 years long apprenticeship. All others- don't count on it.

I don't see anything wrong with that spec. All it requires that the piece be heat treated according to a specified recipe. Perhaps it's just for strain relief, or hydrogen de-embritlement or hardening without a specific Rockwell hardness required.
How and why should you validate?
First off, in previous posts you decribed validation as writing a spec,preparing samples, testing the samples, etc.- all implying that you have to validate your product and not the process.(The two shouldn't be mixed up. Validating your product that may or may not incorporate a heat treatment step in its manufacturing process is a totally different issue! )
In practice,companies don't do heat treatment in -house except if the volume justifies having a dedicated department for that. The usual case is that you go to a subcontractor that already has a heat trement process in place that is validated. Remember that the process has to be validated before you use that process on your part.(Likewise if it's in house the validation of the heat treatment process is done once ( ok ocassionally it needs re-verification) on typical parts used as vehicles for the validation of the process) so it's one time (or yearly) expense with just a negigible effect on the price of a specific product
How do you do that? simply , you visit the place, audit if their furnace has the necesary temperature range, control of temperature and time, that the instruments are calibrated and the operators are trained/certified. In addition you would also audit to verify that they have in place adequate material management control and records to ensure they don't mix up different batches of different clients.
I may have skiped a few points , but that's the general idea.
As opposed to what you implied in previous posts, one doesn't have to pay for that when you go to such a certified processor.
Once your parts have passed through a validated process as above,and receive the adequate paper work attesting to it, it's up to the specific application and criticality to decide how much subsequent testing and at what confidence (sampling plan) should be done on the parts.
And btw, I take your advice and next time I audit a samurai sword-smith shop for compliance to ISO9001, I'll consider skipping the validation of the steel hardening provided he can show me that he's finishd his 20 years long apprenticeship. All others- don't count on it.

I don't think I disagree with anything you've said here, but you've ascribed to me things I didn't say and you don't address anything that I did say.

You always have the option of asking your customer their interpretation of whether a process that affects their product is "special". Most will be happy to help out with that.

You always have the option of asking your customer their interpretation of whether a process that affects their product is "special". Most will be happy to help out with that.

You should be careful; that sort of thinking can lead to workable solutions. :tg:

You should be careful; that sort of thinking can lead to workable solutions. :tg:

My bad.:tg: It does assume your customer understands your processes, however.

The answer is: It depends. Is the heat treatment done solely for hardening the part? Is the hardening of the metal localized to a specific area of the part? Can you effectively measure the hardness of the area without inducing unacceptable denting onto the part?

If you can answer these 3 questions as "yes", then, this is not a process that needs to be validated since you can effectively "inspect" the characteristics at the end of the process, against the requirements.
:agree1::yes:

Hi all! I know I'm late into the discussion. One always hates Old Sayings. But that does not take away from their legitimacy.:D Saying, it depends.

Whether heat treat is a special process will depend on several factors including the type of material, the ability to run post checks, redundant checks, etc.

If you are solution heat treating aluminum, it's probably too late to find out there was a temperature problem when a part gives way under stress 10,000 feet in the air.:D

However, (thanks NADCAP) a Chem Mill process was having to do uniformity surveys, which the owners were strongly objecting. They know their process, and they can tell by the condition of the skin when it comes out if there is a hot spot/ cold spot. Now... would uniformity surveys be helpful? Yes. Did it require validation? No. They could justify the acceptance of the product (depth/deviation of etching) from the final product, and did not need the uniformity survey.

You are heat treating to do something to the product/surface. If the acceptable results of that something can be verified through inspection/testing or some other means, that the validation of the process is optional. If it cannot be conclusively tested, then validation is in the forecast.:2cents:

Already had Enough of heated arguments!!! now it's time for a :cool::agree:

Regards

Arin