Hi,
Our company has just had a major reorganisation. My question addresses the issue of final release / verification of product.

Does there have to be a seperate responsibilty for the release of a product?
Can the Production Manager or personnel working directly under him ,be responsible for the final release of the product? Or as I would prefer to see, a seperate unbiased authority for final release from a department with no vested interest in releasing products to achieve targets?

Comments please. We are moving towards 2000 standard and would like to clear this aspect up soon.

The standards dont specifically state that final release authority has to be independent of manufacturing, but I understand your concerns.

At the end of the day however manufacturing must be accountable for any defects, whether they are finally inspected by a QC function or not - hence so long as there is traceability to the final release authority it shouldnt be a problem in itself.

Denis,

Of course, having a separate unbiased authority, as you say, would be preferred, but the ISO Standard does not restrict who can perform this function. Think about how 2-person organizations might handle this. IMO, a Production Manager or someone working for him could be responsible for this function. I think where a problem may arise could be in the area of continuous improvement. Let's say for instance, a Production Manager is reluctant to reject any incoming material because he desperately needs it for production. If his measurement of nonconforming product goes up, or shows no improvement, then maybe the process should be altered. By the same token, if the person responsible for authorizing release of product feels that they can't reject nonconforming product because of their reporting structure, then you may not see continuous improvement in the number of customer returns.

I think that as long as you can show objective evidence that the process works for you and you maintain customer focus, satisfaction and continuous improvement, then its up to the company to decide tasks and responsibilities.

I hope this helps.


Best Regards,
Hank Fowler
:)

It would be optimal if manufacturing were accountable for the final product. While quality may do a cursory check of the final product, meeting the specifications required happens during the manufacturing process, not after it.

Manufacturing must be accountable for the product they produce. When the quality department gets too involved they will likely become the scapegoat if management and manufacturing consider quality department their "goalie".

Management must let manufacturing be responsible for their product. This might mean a few bumps in the road when something is shipped out of spec because "it is close enough". After a few instances of this, manufacturing will get the message that responsibility equals accountability.

Thanks for the comments so far.

I guess we need to have a "cultural" change to the way we satisfy our customers needs.

Many of the posters are correct in saying that it is ultimately Production dept responsibility to ensure that the product is supplied within specification and satisfies their needs and requirements ( in this case accompanying documentation / reports).

Quality dept should not been seen as policemen in an ideal world, lets hope we can change the culture.

Hi,

We are developing our system at the moment and I am trying to settle the responsibility and form of product release. Can you please comment on our solution? Is it sufficient, correct ?

We have a release only with the final product, before it is released to the customer. The responsibility is always with the department that was responsible for realisation.
In one of the cases product is a report on the result of the activities performed on the units the customer delivers to us. Customer interest is in the fact the we have processed the units and the result of the processing. He receives the report, we keep the units. The way we want to keep the record of the release of this product is to include in each report a sentence "Report verified and approved by Name and date". All of it is in the electronic form only (based on customer request pdf or xls).

Is it a good enough record in the understanding of the 8.2.4 clause? I would like to avoid creating a separate document for listing the reports and approval signatures. The above solution makesthe activity smooth for us.

I will appreciate all your comments:thanks:

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Maja

Hi,

We are developing our system at the moment and I am trying to settle the responsibility and form of product release. Can you please comment on our solution? Is it sufficient, correct ?

We have a release only with the final product, before it is released to the customer. The responsibility is always with the department that was responsible for realisation.
In one of the cases product is a report on the result of the activities performed on the units the customer delivers to us. Customer interest is in the fact the we have processed the units and the result of the processing. He receives the report, we keep the units. The way we want to keep the record of the release of this product is to include in each report a sentence "Report verified and approved by Name and date". All of it is in the electronic form only (based on customer request pdf or xls).

Is it a good enough record in the understanding of the 8.2.4 clause? I would like to avoid creating a separate document for listing the reports and approval signatures. The above solution makesthe activity smooth for us.

I will appreciate all your comments:thanks:

--
Maja

Maja,

You are on the right track. In keeping with the maintaining readily available and retrievable documents is the important part. Its much easier to pull them or email them later when you have them in electronic format. :)

However, many organizations have to also use due diligence in their IT departments, or you yourself if your company is small. Data should/must be backed up on a regular basis in the event of computer viruses, hard drive crashes or server malfunctions. Although they seem obvious as I'm writing them, sometimes it is usually overlooked. :bonk:

Imagine the tap dancing you'll have to do in front of the customer or worse a Regulatory Body because you told them you did have the records, but your computer crashed and unfortunately you can't be of assistance at the moment. :argue:

Hi,

Thank you for the advice. All our system will be electronic based and we will need to resolve many issues related to data storage,security and user rights. I will make sure that it is on my list.

I am also wondering how to secure record when it is in electronic version. In the case I was describing - the record of release will in be the actual product itself. I have two concerns regarding this:

1. Is it a good enough record? Or will the auditor question our way of doing it? Not because of the fact that it is electronic version but questioning if this what we have is a record at all.
2. An electronic document could be changed without traces eg. name of the person that took the responsibility initialy, can be changed. A record by definition should not be changed once it is made. It is supposed to document the past. I am wondering how to tackle that. :confused:

I am really not sure how to do it right. I do not have the competence in IT so it is hard for me to see possible solutions. I will have a meeting with IT responsible next week so I need to tell him exactly what do I require from the electronic records that we are supposed to have. If I could also get some advice on that I would realy appreciate.
:thanx:

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Maja