Engineering Drawing = Record or Document?

[Inclag]

Hi All,

Preface; I'm not a QS Manager or Quality Engineer, but have done a fair amount of research and self learning to push the organization I'm in towards getting ISO 13485 certification.

Can someone please tell me if a completed engineering drawing is handled as a record or a document?

My perspective on this was that;

1) A engineering drawing template is viewed as a form or document and therefore adheres to document control procedures
2) A completed engineering drawings for a part, assembly, ect. is viewed as a records and therefore should comply to an organizations record control procedures

I'm in discussions with someone that is more senior than myself and has a boatload of experience in med device design but also doesn't have a formal quality background either so our views differ on this and some clarification for us would be helpful.

Thanks!

 

[Ninja]

Knowing that the words can mean different things...

An engineering drawing template is a useful tool...but not a necessary one...a blank piece of paper is just as viable a starting point. It's up to your company whether to use it or not...so it's up to you whether or not to control it. What is the risk if you don't?

A completed engineering drawing (assuming approval by mgmt/end user or other) is something that must be followed henceforth...thus control is necessary to make sure that unapproved drawings are not used and only approved ones are used...control is what makes this happen.

It is the control that is necessary...possibly in both cases...not whether you call it one word or the other.

 

[howste]

First let's get the definitions:

document
information and the medium on which it is contained

record
document stating results achieved or providing evidence of activities performed

The short answer is that a completed engineering drawing can be both. But the primary purpose of a drawing is as a document.

It contains information which is used to create parts, so it's a document. Once parts are made using the drawing then it can become a record of what the part was made to. When a new version of a drawing is issued then the (obsolete) drawing would be a record of how the part used to be made.

 

[Inclag]

First let's get the definitions:


The short answer is that a completed engineering drawing can be both. But the primary purpose of a drawing is as a document.

It contains information which is used to create parts, so it's a document. Once parts are made using the drawing then it can become a record of what the part was made to. When a new version of a drawing is issued then the (obsolete) drawing would be a record of how the part used to be made.

OK...

So a quality person once told me that anything that was signed off on and had a revision could be considered a record. This doesn't necessarily mean that a document can't also be a record (SOP's for example). I suppose from a manufacturer's perspective, a completed and signed engineering drawing would be viewed as a document since that is what a finished good is made from. Therefore the drawing is a document and the part is a record.

This logic also makes sense to me if I were at a large horizontally integrated firm that did design & development and manufacturing, or was a firm that managed the production of finished goods with outside vendors, however, my organization is a design and development firm only, and we neither produce or manufacture finished goods. Our clients are responsible for and take over this as we near pilot build typically.

I guess maybe what I'm getting hung up on is it seems that since we're not responsible for the manufacture and production of the finished products then we should not be responsible for reviewing all engineering drawings yearly as part of a doc control procedure. This is a thing that my colleague is suggesting we do. We're a small consultancy with several clients and this seems incredibly wasteful since we're handing off the work and responsibility to our customers so from my point of view, the engineering drawing is considered a record at our firm. For our customer whom uses the drawings to produce parts and maintain a product line, the drawing would be considered more of a document.

Does the above logic make sense? I'd like to avoid wasteful time reviewing completed engineering drawings once a year if it is not necessary based on the type of activities our company completes in the development process.

 

[Sidney Vianna]

Can someone please tell me if a completed engineering drawing is handled as a record or a document?

I agree with Howste, but keep in mind that ISO 13485:2016 specifically stipulates at the very last sentence of 7.3.4 that records of the design and development outputs shall be maintained. Engineering drawings are one of the most typical design outputs, thus, the (ISO 13485) standard clearly wants you to ensure they are kept as part of the device history file (as records).

 

[Inclag]

Knowing that the words can mean different things...

An engineering drawing template is a useful tool...but not a necessary one...a blank piece of paper is just as viable a starting point. It's up to your company whether to use it or not...so it's up to you whether or not to control it. What is the risk if you don't?

A completed engineering drawing (assuming approval by mgmt/end user or other) is something that must be followed henceforth...thus control is necessary to make sure that unapproved drawings are not used and only approved ones are used...control is what makes this happen.

It is the control that is necessary...possibly in both cases...not whether you call it one word or the other.

Understood that control is necessary.

I think where I'm getting confused is that a colleague as part of the doc control procedure is suggesting that we have an periodic (annual) document review. I believe that this is being implemented in response to ISO13485 Clause 4.2.3 b.

"b) to review and update as necessary and re-approve documents,"

The way I read ISO 13485, I don't understand how this applies to engineered drawings. If we want to use a controlled drawing template, then periodic review of them would likely be helpful in improving them over time. Since this clause states 'as necessary' logic implies to me (see my first response) that it is not necessary for us to need to review and re-approve engineering completed engineering drawings.

Is this a fair way of interpreting the ISO standard based on my description of what our company does?

 

[howste]

More context helps us to understand what you're looking for. It sounds like your drawings are part of your product. As Sidney said, in your system they would primarily be considered records. If you have procedures or work instructions that you use to develop a design, they would be examples of documents that ISO 13485 would require you to review and update. Others would be procedures for document control, control of records, management review, design & development, design transfer, design change control, purchasing, servicing, etc.

 

[Golfman25]

Understood that control is necessary.

I think where I'm getting confused is that a colleague as part of the doc control procedure is suggesting that we have an periodic (annual) document review. I believe that this is being implemented in response to ISO13485 Clause 4.2.3 b.

"b) to review and update as necessary and re-approve documents,"

The way I read ISO 13485, I don't understand how this applies to engineered drawings. If we want to use a controlled drawing template, then periodic review of them would likely be helpful in improving them over time. Since this clause states 'as necessary' logic implies to me (see my first response) that it is not necessary for us to need to review and re-approve engineering completed engineering drawings.

Is this a fair way of interpreting the ISO standard based on my description of what our company does?

Document vs record really is semantics. I am not sure you would want to review prints or any document for that matter once a year. But, if you choose, you could exempt prints from this annual review. Frankly, I would only review and update when necessary -- like a change, improvement project, etc.

 

[Ron Rompen]

I agree with your assessment in your first post, Inclag. The template is a document, and once it contains information (i.e. a completed drawing) then it becomes a record.