Controlled Forms or documented requirements for records?

[ThatSinc]

Hi All,

Looking for some guidance on forms, specifically with regards to review of customer requirements 7.2.2 and control of documents 4.2.4

The devices being sold are configured and have multiple options available.
Currently the sales order process uses "quote master templates" that include each product option with its associated price.
These are required for each customer enquiry and the resulting quote is sent back to the customer for review and approval, and then this becomes the record of the review of customer requirements.

These forms are not controlled in accordance with 4.2.4, they are updated as prices change and as new options become available with no identification of the date of revision, and previous copies are overwritten.
The company is small and only one person performs the sales process

Whilst I appreciate that nowhere in 7.2 states that a procedure is required, the sales order procedure doesn't include reference to use of these quote masters, only that a final acknowledgement of the order must be provided once customer requirements are confirmed and accepted.

My questions are;

1. would you consider these templates "documents required by the quality system" - and thus subject to control as per 4.2.4?
2. would it be acceptable to document (in a procedure or otherwise) what the minimum requirements are for the record of the review and then the quote master itself becomes irrelevant as long as the record meets the documented requirements?
3. where 13485 doesn't require a procedure for any of the customer related processes in 7.2, I've never seen anywhere that doesn't document a sales order process - is there a better way?

I'm moving from a company that had 1,001 controlled forms for everything, so trying to avoid creating new forms where they're not strictly necessary.

Thanks all,

TS.

 

[John C. Abnet]

Good day @ThatSinc ;
The short answer is a question....
What does your organization need to ensure the intended results?

Consider a principle I coined years ago, which I call the "WRONG or GONE" principle.

If the document/information is WRONG or GONE, can it lead to a nonconformity? If yes, then what controls are necessary to prevent the nonconformity?

Regardless, be selfish. It is YOUR organization's QMS.

Hope this helps.
Be well.

 

[ThatSinc]

Hi John,

I like that approach, and at this time the process kind of sits in the middle of both potentially leading to an NC.

The appearance of the quote isn't important to quality, it could be written on the back of a napkin as long as it has the right information; quote number, parts lists as per approved parts drawings, prices, any other customer requirements, approvals. Therefore the form isn't important and the sales process could simply require these things to be documented.

However the approved parts lists are not referred back to each time to verify, these parts lists are pre-filled onto the forms for ease of use. If the parts are wrong on the form, and it gets approved and goes to production as a build order, which is simply the approved quote with prices removed, then there's a problem.

Thanks for the help.

TS.