What Exclusions to the ISO 9001 standard are allowed? Clause 1.2

[samsung]

Exclusions to the ISO standard

I am working in a company dealing with production of cement. The quality parameters are specified by statutory bodies. One of the most important quality parameter is its Final Compressive strength which can only be determined after the cement cube specimen is cured under water for 28 days. No company can wait for 28 days and despatch the product as soon as it is ground.

My question is that if we can still exclude the clause 7.5.2 (9001) in spite of the fact that numerous intermediate checks on other quality parameters are exercised to ensure the quality to conform to the relevant national standards ?

Help much appreciated,

Best regards,

 

[Sidney Vianna]

Re: Exclusions to the ISO standard

I am working in a company dealing with production of cement. The quality parameters are specified by statutory bodies. One of the most important quality parameter is its Final Compressive strength which can only be determined after the cement cube specimen is cured under water for 28 days. No company can wait for 28 days and despatch the product as soon as it is ground.

My question is that if we can still exclude the clause 7.5.2 (9001) in spite of the fact that numerous intermediate checks on other quality parameters are exercised to ensure the quality to conform to the relevant national standards ?

No, you can not exclude it. It is a critical aspect of your product validation. The questions I have for you are:
Do you have full traceability of the batch, post delivery? Can you tell where the product is at (or who has it), in case the specimen tests show unacceptable properties?
Does the customer know that the product might have to be recalled?
Have you ever had a test specimen fail?

 

[somerqc]

Re: Exclusions to the ISO standard

Short answer - no. You need to verify all parameters - not just some (especially for regulatory requirements - do you want to risk government visits?)

 

[samsung]

Re: Exclusions to the ISO standard

No, you can not exclude it. It is a critical aspect of your product validation. The questions I have for you are:

"Do you have full traceability of the batch, post delivery?"
Yes, we have full traceability of the batch despatched. Every bag is marked with Week No., Month & year and can be traced back to the quality of that batch.

"Can you tell where the product is at (or who has it), in case the specimen tests show unacceptable properties?"
By the time, 28 days results are achieved, in all probability, the product (mostly) might have been consumed.

"Does the customer know that the product might have to be recalled?"
May or may not because of lack of education in our country, most of the customers may not be aware of this critical aspect of quality verification procedure, yet, by experience, they know that it might be recalled.

"Have you ever had a test specimen fail?"

No, we never had any specimen failed in any of the quality parameters because as part of the company policy, we always keep the level of quality of the product far ahead of the 'Statutory Requirements' (may it not be too 'far ahead' of the customer expectation).

If we have to include the clause, I don't find a way to devise a method for process validation.

Regards,

 

[Sidney Vianna]

Re: Exclusions to the ISO standard

If we have to include the clause, I don't find a way to devise a method for process validation.

Based on what you describe, the testing of the specimens consitute process validation and revalidation, as well as product monitoring/acceptance. At least, when it comes to "final compressive strenght" characteristic. I don't know if you have to validate the process and monitor the product for other characteristics....

Cement production. A lot of greenhouse gas emmissions...

 

[samsung]

Re: Exclusions to the ISO standard

Based on what you describe, the testing of the specimens consitute process validation and revalidation, as well as product monitoring/acceptance. At least, when it comes to "final compressive strenght" characteristic. I don't know if you have to validate the process and monitor the product for other characteristics....

Cement production. A lot of greenhouse gas emmissions...

I too apprehended that the process may warrant some validation but was never sure of it. Thanks for your response. One of the ways (a test procedure given in the national standard) that can be used to validate the process is to prepare actual cement in laboratory mill by grinding Gypsum & Clinker (exactly how is done at the final stage of production in the grinding mill. Clinker is an intermediate product-just before the final stage). Can the test results of this sample be used to validate the process if the final product has not been shipped? 15,000 tonnes or 300000 bags per day!

In this situation, I foresee another problem. It is a continuous process (not batch) and cement is stored in many big silos each amounting 10,000 Tonnes. Sample is taken every hour during production (at final stage) for subsequent testing & measurement. Product is not traceable as long as it resides inside the silos; only when it is extracted for packing in bags, traceability cab be ensured through sampling from bags during packing.

Complex process. I am interested to know what other cement companies around the globe do. If you have any info. about this or similar category of products, please do share with me.

(Yes, lot of Green house emissions in the form of CO2 from two sources - Limestone & Coal. Since cement is one among the most basic needs of all human beings, it may, upto some extent, be excused for increasing the 'calculated' Global Warming. Surprisingly, a cement process, on the other hand, is contributing a lot in reducing Global Warming & Greening the environment by way of consuming enormous amount of solid waste like fly ash etc. which otherwise would be a potential health & environmental nuisance. Fly ash, being as fine as cement, makes very good cement without consuming any resource such as coal or electricity.)

Best regards,

 

[samsung]

Re: Exclusions to the ISO standard

Short answer - no. You need to verify all parameters - not just some (especially for regulatory requirements - do you want to risk government visits?)

The regulatory requirements too don't obligate us to withheld the shipment till the final quality verification is done but the manufacturer has to ensure that the product conforms to relevant specs. (By all means, it is logically as well as technically not 'ensured' but based on the experience & intermediate controls one may assume it to be OK as planned.)

Regards,

 

[harry]

Re: Exclusions to the ISO standard

I am working in a company dealing with production of cement. The quality parameters are specified by statutory bodies. One of the most important quality parameter is its Final Compressive strength which can only be determined after the cement cube specimen is cured under water for 28 days. No company can wait for 28 days and despatch the product as soon as it is ground.

My question is that if we can still exclude the clause 7.5.2 (9001) in spite of the fact that numerous intermediate checks on other quality parameters are exercised to ensure the quality to conform to the relevant national standards ?

Help much appreciated,

Best regards,

It is precisely because no body can wait for 28 days that a number of test are carried out to predict and give confidence (VALIDATE) that the final product does meet requirements. You also have the 3 days and 7 days testing results, some accelerated test which may or may not be done depending on the technology employed and a host of many others. Many of these will in some ways indicate if your product can meet requirements. Therefore validation is fundamental in your line of business and can never be excluded.

 

[Ajit Basrur]

Re: Exclusions to the ISO standard

........... One of the most important quality parameter is its Final Compressive strength which can only be determined after the cement cube specimen is cured under water for 28 days. No company can wait for 28 days and despatch the product as soon as it is ground.

Just curious ... have you checked with other manufacturers on how they tackle this "statutory" specification since its statutory, all manufacturers would be bound by this requirements ?

 

[harry]

Re: Exclusions to the ISO standard

Just curious ... have you checked with other manufacturers on how they tackle this "statutory" specification since its statutory, all manufacturers would be bound by this requirements ?

Statutory requirements usually relates to the technical specifications such as minimum required compressive strength at 28 days, maximum chloride content, setting characteristics and some others. How you design your product, test, manufacture, validate and others are entirely up to your own.

Over most part of the whole world, manufacturers either follow the practices of the Cement and concrete associations of America or UK.