Who should be the person to release product to customer

DRDDO · Jun 6, 2009

Dear All
In Thailand, we (mean many MR & me too, except Non-Thai) have a big problem concerning who should be the person autholizing-release of product for delivery to customer as mention in (ISO 9001:2008 & ISO 13485;2003) clause 8.2.4.
and what he should or shall do to release the product ( I beleve not only sign the delivery document...)
:frust:

DRDDO

Polly Pure Bread · Jun 6, 2009

DRDDO said:
Dear All
In Thailand, we (mean many MR & me too, except Non-Thai) have a big problem concerning who should be the person autholizing-release of product for delivery to customer as mention in (ISO 9001:2008 & ISO 13485;2003) clause 8.2.4.
and what he should or shall do to release the product ( I beleve not only sign the delivery document...)

DRDDO

authorities for the disposition of products after verification should be identified

JaneB · Jun 6, 2009

DRDDO said:
who should be the person autholizing-release of product for delivery to customer as mention in (ISO 9001:2008 & ISO 13485;2003) clause 8.2.4.
and what he should or shall do to release the product ( I beleve not only sign the delivery document...)

I can't speak for 13485, but in 9001, it requires you to:
have records that indicate the person(s) authorizing release of product for delivery to the customer' 4.2.4

That means at least one record that shows at least one specific role/person (and who that was) decided that product X (or batch X of product) was OK to go.

Bottom line: before it leaves you who produced it and are selling it, you should have a way of demonstrating (here, to an external party) that it met all the requirements.

Who decides that? And what kind of record/s are needed? You get to determine that. But whoever it is should have the authority to decide it and be competent to make that decision, and have some kind of criteria on which that decision is made (as opposed to 'gut feel').

I mean, you could have the truck driver authorising release, but you'd have trouble convincing me (let alone anyone else) that a truck driver had the necessary competency (per 6.2 of ISO 9001) to distinguish between product that was OK to go and product that wasn't.

Some ways of achieving this (for example) might be to have inspection points along the way, with a signoff /acceptance of satisfactory pass on the final inspection being the record of release.

Signing a 'delivery docket' might be OK, but only if there were sound inspection processes that ensured that before it got to the delivery stage it had been inspected by someone competent and = OK.

But if it's simply a matter of something being moved across to despatch (without anyone checking final) and then the warehousing person or whoever sending it out... then that sounds a bit loose, to put it mildly, and not likely to meet the requirements.

Hope this helps.

Ajit Basrur · Jun 7, 2009

DRDDO said:
Dear All
In Thailand, we (mean many MR & me too, except Non-Thai) have a big problem concerning who should be the person autholizing-release of product for delivery to customer as mention in (ISO 9001:2008 & ISO 13485;2003) clause 8.2.4.
and what he should or shall do to release the product ( I beleve not only sign the delivery document...)

DRDDO

Since this question is raised in the ISO 13485 forum, the answer is "Quality Assurance".

They will gather all the pertinent documents vix. Manufacturing records, Quality Control testing reports, all Warehousing particulars on raw materials and packaging materials and then RELEASE the batch that meets the customer specifications.

DRDDO · Jun 7, 2009

JaneB said:
I can't speak for 13485, but in 9001, it requires you to:
have records that indicate the person(s) authorizing release of product for delivery to the customer' 4.2.4

That means at least one record that shows at least one specific role/person (and who that was) decided that product X (or batch X of product) was OK to go.

Bottom line: before it leaves you who produced it and are selling it, you should have a way of demonstrating (here, to an external party) that it met all the requirements.

Who decides that? And what kind of record/s are needed? You get to determine that. But whoever it is should have the authority to decide it and be competent to make that decision, and have some kind of criteria on which that decision is made (as opposed to 'gut feel').

I mean, you could have the truck driver authorising release, but you'd have trouble convincing me (let alone anyone else) that a truck driver had the necessary competency (per 6.2 of ISO 9001) to distinguish between product that was OK to go and product that wasn't.

Some ways of achieving this (for example) might be to have inspection points along the way, with a signoff /acceptance of satisfactory pass on the final inspection being the record of release.

Signing a 'delivery docket' might be OK, but only if there were sound inspection processes that ensured that before it got to the delivery stage it had been inspected by someone competent and = OK.

But if it's simply a matter of something being moved across to despatch (without anyone checking final) and then the warehousing person or whoever sending it out... then that sounds a bit loose, to put it mildly, and not likely to meet the requirements.

Hope this helps.

Perfect anwer
:thanks:

DRDDO

SteveK · Jun 8, 2009

Ajit Basrur said:
Since this question is raised in the ISO 13485 forum, the answer is "Quality Assurance".

They will gather all the pertinent documents vix. Manufacturing records, Quality Control testing reports, all Warehousing particulars on raw materials and packaging materials and then RELEASE the batch that meets the customer specifications.

I would beg to differ on this. My thought was indeed that "Quality" was the final sign off for release of product (medical devices). However my auditor decided this was not the case, it was the person in charge of the production department because he was responsible for the shipping operation. Nearly got a NC for this. :2cents:

Ajit Basrur · Jun 8, 2009

SteveK said:
I would beg to differ on this. My thought was indeed that "Quality" was the final sign off for release of product (medical devices). However my auditor decided this was not the case, it was the person in charge of the production department because he was responsible for the shipping operation. Nearly got a NC for this.

The FDA (Food Drug Administration) requires the release of bacthes from the Quality unit.

Allan66 · Jun 8, 2009

SteveK said:
I would beg to differ on this. My thought was indeed that "Quality" was the final sign off for release of product (medical devices). However my auditor decided this was not the case, it was the person in charge of the production department because he was responsible for the shipping operation. Nearly got a NC for this.

It is always a difficult area when an auditor has a strong opinion which differs from that of the client - or in the case of products being sold to multiple companies - other auditors. In these cases it is often useful to go back to the specification defining the requirements. With the 'new' answer, I would quite strongly question how the person in charge of a production department head could be considered to have the necessary degree of independence to authorise a final release, so I am with Ajit on this one. Do you know how experienced your auditor was in this field?

Chris Ford · Jun 8, 2009

Ajit Basrur said:
The FDA (Food Drug Administration) requires the release of bacthes from the Quality unit.

Actually, the Quality System Regulation does not require a quality function to be responsible for final release of product. The requirements are generally the same as 13485.

21CFR820.80(d)Final acceptance activities. Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until:
(1) The activities required in the DMR are completed;
(2) the associated data and documentation is reviewed;
(3) the release is authorized by the signature of a designated individual(s); and
(4) the authorization is dated.
(e)Acceptance records. Each manufacturer shall document acceptance activities required by this part. These records shall include:
(1) The acceptance activities performed;
(2) the dates acceptance activities are performed;
(3) the results;
(4) the signature of the individual(s) conducting the acceptance activities; and
(5) where appropriate the equipment used. These records shall be part of the DHR.

Qualqueen · Jun 8, 2009

DRDDO said:
Dear All
In Thailand, we (mean many MR & me too, except Non-Thai) have a big problem concerning who should be the person autholizing-release of product for delivery to customer as mention in (ISO 9001:2008 & ISO 13485;2003) clause 8.2.4.
and what he should or shall do to release the product ( I beleve not only sign the delivery document...)

DRDDO

We're also an ISO 9001 / 13485 company and what JaneB states is indeed the answer.

Some ways of achieving this (for example) might be to have inspection points along the way, with a signoff /acceptance of satisfactory pass on the final inspection being the record of release.

We didn't name any specific person or department. We simply stated records provide the evidence of product conformance, indicating the person authorizing the release of the product.

In our cross reference table for 8.2.4 are our WI's for inspection activities, sampling plan and so on with a needed sign-off for each phase of the product. By the time it's in shipping, all of the production has been inspected at incoming, inprocess and final along with an inspection card of acceptance. A traveler and copy of the process sheet accompany finished product to shipping and they sign off. This is all kept on file and that's our record of release....in one neat bundle without naming one specific person.

Who should be the person to release product to customer

DRDDO

Polly Pure Bread

JaneB

Ajit Basrur

DRDDO

SteveK

Ajit Basrur

Allan66

Chris Ford

Qualqueen

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