7.2 Customer-related Processes. Does Quote Form need to be Controlled

Sylvia16

Registered
I'm trying to determine if the form we use for Quotes needs to be a controlled document. Clause 7.2. states that "This review shall be conducted prior to the organization's commitment to supply product to the customer (e.g. submission of tenders, acceptance of contracts or orders ...". This leads me to believe that there needs to be a Quotes process in place and that the form used for Quotes needs to be ECO-controlled (ie: a QMS document). Is this correct?
Thanks!
 

yodon

Leader
Super Moderator
The requirement is to be able to provide evidence that you reviewed the customer order. It does not require a stand-alone record.

If you use the form to fulfill the requirement, that's fine.

Whether you choose to control the form or not is also your choice. Forms are just a means to an end. If it helps ensure things are done the right way every time, then controlling is probably important. If you have reason to need to always adapt the form for the particular case and content doesn't need to be written in stone, then you'll be backing yourself into a corner by trying to control it. What works for you?
 

Sylvia16

Registered
The requirement is to be able to provide evidence that you reviewed the customer order. It does not require a stand-alone record.

If you use the form to fulfill the requirement, that's fine.

Whether you choose to control the form or not is also your choice. Forms are just a means to an end. If it helps ensure things are done the right way every time, then controlling is probably important. If you have reason to need to always adapt the form for the particular case and content doesn't need to be written in stone, then you'll be backing yourself into a corner by trying to control it. What works for you?
Thanks for replying! In your experience, what other modes of evidence are used if not by referencing a quote? We have a paper-based QMS and sales-order "system".
 

yodon

Leader
Super Moderator
We're a contract R&D shop so we do things a bit differently. Our orders are in the form of a work order or statement of work whose scope has already been hammered out between us and our customer. The fact that we have one is evidence that we reviewed the order.
 

Sylvia16

Registered
We're a contract R&D shop so we do things a bit differently. Our orders are in the form of a work order or statement of work whose scope has already been hammered out between us and our customer. The fact that we have one is evidence that we reviewed the order.
I see. I work for a medical device manufacturer and until we have an ERP System in place, the paper quote (form) will have to act as part of the evidence for an order review.
Thanks again for taking the time to reply to my request - greatly appreciate it!
 

Chrisx

Quite Involved in Discussions
In our QMS, the contract review process covers clause 7.2. It is initiated by receipt of a PO from the customer, not a request for quote. Technically, the quote would not be part of the contract review at that stage in our process. At completion of contract review we either refuse the order (very rare) or send an order acknowledgment. Refusal would only occur if we feel that we cannot fulfill the requirements of the PO. Whether the quote form would need to be controlled would all depend upon how you define the process in your QMS.
 

mattador78

Quite Involved in Discussions
In our AS9100 we contract review at quotation to determine whether we have the capabilty of completing the required request. We then perform a secondary contract review against the PO to confirm the customer is asking for the same as the quote. Our contract review form is a controlled document our quote and secondary contract review are built into the ERP system we use.
 

CUSpaceCowboy07

Registered
So we also have a paper based QMS system and we use a sales order review packet. It has sections for Engineering, Quality, and Operations to document their part of the review process and sign off is required. Engineering's review section includes stuff like "what revision are the work instructions at, are there changes that need to be made to the work instructions, etc etc" quality's review includes "are there any open corrective actions, do you have current copies of all applicable specs, are there any open corrective actions, is the FAIR current or is one needed, are there any new requirements, etc etc" operation's review includes "are there any outside services that are needed, what are the lead times, etc etc" This serves as evidence a review was conducted and who conducted the review. Also serves to check some boxes for Planning of Product Realization Processes,
 
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