Tell me why I should no longer reference MIL STD 105E?

[kreco]

Are there any valid reasons as why I should discontinue referencing the MIL-STD-105E specification? As far as I knew this was still a valid standard, it just will no longer be updated. I see no reason not to continue referencing it. Please enlighten me if you know of anything that says "you shall not use".

My reasoning for utilizing the 105E is as simple as we currently have that standard in our possesion, why should the company pay another $100+ to obtain essentially the same information buy purchasing the ANSI standards?

I recently went through a customer audit (not a registrar) and he seems to have many of his own interpretations as to ISO 9001 requirements like "you must have an approved supplier list" and "customer complaints should have it's own work instruction and not be incorporated into another because it has its own section of the ISO standard" and "we certainly would like you to use the same sampling plan we use".

Please note I did do a search but all I came back with is "what are the differences between MIL-105 & ASNI/ASQC Z1.4 & Z1.9" and from what I understand there is very little difference.

 

[Jim Wynne]

Re: Tell me why I should not longer reference MIL STD 105E

Are there any valid reasons as why I should discontinue referencing the MIL-STD-105E specification? As far as I knew this was still a valid standard, it just will no longer be updated. I see no reason not to continue referencing it. Please enlighten me if you know of anything that says "you shall not use".

My reasoning for utilizing the 105E is as simple as we currently have that standard in our possesion, why should the company pay another $100+ to obtain essentially the same information buy purchasing the ANSI standards?

I recently went through a customer audit (not a registrar) and he seems to have many of his own interpretations as to ISO 9001 requirements like "you must have an approved supplier list" and "customer complaints should have it's own work instruction and not be incorporated into another because it has its own section of the ISO standard" and "we certainly would like you to use the same sampling plan we use".

Please note I did do a search but all I came back with is "what are the differences between MIL-105 & ASNI/ASQC Z1.4 & Z1.9" and from what I understand there is very little difference.

There are two issues here: customer requirements, and use of withdrawn MIL standards. For the latter, there's no reason in particular that you shouldn't use it internally if it serves a useful purpose, and you see no utility in "upgrading" to the ANSI/ASQC version(s).

On the other hand, if your customer expects something else, you either have to talk the customer out of it, or bite the bullet, spend $100, and get the newer standard. I recommend the latter, mainly because clinging to old MIL standards often gives the appearance of not keeping up with the times, whether there's any validity to that perception or not.

As for your customer's fanciful interpretations of the standard, welcome to our nightmare.

 

[kreco]

Re: Tell me why I should not longer reference MIL STD 105E

Thanks for the quick response. We received a formal audit report from this auditor and we had to respond. I basically told him we would consider the alternatives. His response to that basically was "no, you will obtain them".

It is not like they have ever made it known to us prior to this audit that this was a requirement of theirs. So does something like this noted in an audit report count as a "customer requirement"? Or would it need to be communicated to us during the BSQ stage of the game in a PO or something?

Your point about keeping up with the times is a good one and I suppose it can't hurt even though we're a very cash poor org at the moment

 

[CarolX]

Re: Tell me why I should not longer reference MIL STD 105E

Unless the customer is stating specifically that you must use the new standard - why not skin this another way, and maybe make life easier for your inspectors.

Write your own sampling procedure and copy the tables from the Mil standard for normal, tightened and reduced inspection.

 

[Jim Wynne]

Re: Tell me why I should not longer reference MIL STD 105E

Thanks for the quick response. We received a formal audit report from this auditor and we had to respond. I basically told him we would consider the alternatives. His response to that basically was "no, you will obtain them".

It is not like they have ever made it known to us prior to this audit that this was a requirement of theirs. So does something like this noted in an audit report count as a "customer requirement"? Or would it need to be communicated to us during the BSQ stage of the game in a PO or something?

Your point about keeping up with the times is a good one and I suppose it can't hurt even though we're a very cash poor org at the moment

How far you want to push this is dependent on a lot of factors we can't know about. You woould be within your rights, for example, to balk at adopting new requirements that weren't a part of the original agreement. It's not a good thing to allow customers to pull stuff out of their posteriors all the time, but it's a judgment call, and basically it boils down to whether the cost of a copy of a standard is worth not alienating the customer, or whether you think that you need to stand your ground.

 

[qualitymanager]

Re: Tell me why I should not longer reference MIL STD 105E

Hi kreco,

Sounds to me that one angle would be to take the new "requirements" and run them back through the "Determination of Customer Requirements" section, where they speak about changes (in this case additions) to the original contract terms.

If you speak with your Accounting and/or Sales people, they may decide that there is an additional cost to the customer - what would the auditor say if the new conditions (and you HAVE to make sure they are not specified in the original agreement) raise the price you charge his company?

 

[Ajit Basrur]

Are there any valid reasons as why I should discontinue referencing the MIL-STD-105E specification? ...............

The valid reason is that it is INVALID. From a quality systems perspective, you can not use obsolete / invalid documents.

As per ISO 13485, section 4.2.3, you are supposed to control the quality management system documents by preventing the accidental use of obsolete documents.

Similarly, as per 21 CFR Part 820 from FDA, section 820.40 on Document Controls say - "Obsolete documents must be removed from circulation and documentation of document approval must include a signature and date. Removal (or prevention of use) of obsolete documents must be verified."

On another note, if you donot want to buy the new ANSI standard, why dont you get the Customer issue you the sampling plan and in turn you include the same in your procedures ?

 

[Jim Wynne]

The valid reason is that it is INVALID. From a quality systems perspective, you can not use obsolete / invalid documents.

Sorry, Ajit, but it's been withdrawn by the US DoD, but that doesn't mean that it's "invalid." The tables, OC curves and statistics will never be invalid so long as anyone finds them useful for their own purposes.

As per ISO 13485, section 4.2.3, you are supposed to control the quality management system documents by preventing the accidental use of obsolete documents.

If my company establishes 105x as its standard for sampling inspection, it is not "obsolete," so there is no issue regarding accidental use.

On another note, if you donot want to buy the new ANSI standard, why dont you get the Customer issue you the sampling plan and in turn you include the same in your procedures ?

Yes--good idea. I think I'd just spend the $100 and get it overwith, but if the customer insists on it being used, they should be willing to share.

 

[Bev D]

Jim is correct.
Mil Std 105 is not invalid (being without foundation or force in fact, truth, or law). the statistics worked then and they worked now as well as they did then.
the ISO reference concerning obsolete documents is intended to control use of procedures that you have superceded. There really is nothing substantively different from the Mil Std version to the ANSI version.

(I will say that I do not use either version for categorical data, nor do my suppliers use either version for our products. We utilize Rejectable Quality Levels, not Acceptable levels and we go straight to the applicable distribution: Poisson, Binomial or Hypergeometric. We do not incorporate lot sizes as part of the sample size selection process but do ensure a random selection method. We are also highly biased to continuous data plans and allow the submission of control charts if shipped quality meets acceptable levels and the process is proven to be stable and capable. SO in this case I have determined that the Mil Std method is "not applicable" - and one could argue that I have therefore made it obsolete for our uses. But I prefer to say it's not preferred...if someone uses it, I won't freak out.)

 

[Coury Ferguson]

I have moved this post to this forum since it is relating to Sampling.

I agree with most of the posts. Using an invalid specification shouldn't cause any issues, unless the issues arise from your customers. As for the valid sampling standard, spend the money and incorporate the sampling plan, in my opinion.