Engineering Drawing = Record or Document?

#1
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!
 
Elsmar Forum Sponsor

Ninja

Looking for Reality
Trusted Information Resource
#2
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

Thaumaturge
Super Moderator
#3
First let's get the definitions:
ISO 9000:2015 said:
document
information and the medium on which it is contained
ISO 9000:2015 said:
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.
 
#4
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

Post Responsibly
Staff member
Admin
#5
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).
 
#6
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

Thaumaturge
Super Moderator
#7
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

Trusted Information Resource
#8
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

Trusted Information Resource
#9
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.
 
Thread starter Similar threads Forum Replies Date
D Engineering Drawing Review and Approval Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
T Engineering Drawings - Once a customer has signed off on an engineering drawing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L How to document use of wrong engineering drawing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 22
K Engineering Drawing Convention for Units of Measure Other ISO and International Standards and European Regulations 8
C Engineering Drawing Pre-Release/Advance Release Process Document Control Systems, Procedures, Forms and Templates 5
J Drawing Approvals vs. Engineering Order Approvals Document Control Systems, Procedures, Forms and Templates 2
M Engineering Drawing Number Procedure Requirement - ISO 13485:2003 4.2.1 d)? Document Control Systems, Procedures, Forms and Templates 3
Y What shall we do on Engineering Drawing mentioned in APQP APQP and PPAP 8
B Drawing Title Blocks - Control / Number them? Engineering Drawing Practices Y14.100M Document Control Systems, Procedures, Forms and Templates 14
Marc Definition Critical Characteristic Symbol - ASME Y14.100 Standard (Engineering Drawing Practice) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
Marc Job Opportunity - Engineering Technician - Suspense 23 Sept 2020 Job Openings, Consulting and Employment Opportunities 0
J UCLA extension Medical Device Engineering Program Training - Internal, External, Online and Distance Learning 0
G Engineering retest in line - Machine stability issues IATF 16949 - Automotive Quality Systems Standard 8
A FDA and NB audit of Engineering Drawings in DHF and DMR. Medical Device and FDA Regulations and Standards News 1
I Good resources for learning statistics (quality engineering related) Statistical Analysis Tools, Techniques and SPC 10
B Lessons Learned Implementing ISO 50001 (Chemical Engineering Progress) Other ISO and International Standards and European Regulations 0
G Engineering Specifications - APQP APQP and PPAP 5
O Vendor vs Engineering Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C E signatures on Engineering Change Notes AS9100 / AS9116 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Icy Mountain Engineering Change Order...Modification Order Document Control Systems, Procedures, Forms and Templates 18
jjmusicjr Implementing Machine Replacement Part Reverse engineering technology Manufacturing and Related Processes 3
T Why are most companies have Quality reporting to Engineering or Operations and not to CEO ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
I Document templates required for ISO ISO 45001 - Engineering Construction company Occupational Health & Safety Management Standards 5
R The alignments and contradiction in Quality Engineering and management between the Automotive and Aerospace industry AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
V Thinning percentage in sheet metal forming per SES (Suzuki Engineering Standard) Manufacturing and Related Processes 1
P Usability/human factors engineering requirement (standard) for IVD medical device Other Medical Device Related Standards 2
R Creating WIs for a Heavy Civil Engineering Services company Document Control Systems, Procedures, Forms and Templates 19
S Ballooned Drawings and Engineering Changes Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
J Class 1 Medical Device ECR (Engineering Change Request) Changes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Tactics to work with Design Engineering on CAR Nonconformance and Corrective Action 3
D Are detailed engineering requirements Design Inputs or Design Outputs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
2 First Article Requirements for Revision Changes of Engineering AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S Engineering change order versus a design change request ISO 13485:2016 - Medical Device Quality Management Systems 1
C Applicability of ISO 9001:2015 Section 8.5 - Engineering company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T Setting up a quality department in an Engineering Firm Quality Management System (QMS) Manuals 11
C ISO 9001 2015 Documentation for Engineering and Design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
G ISO 9001:2015 8.3 Design and Development (in Civil Engineering) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G FAI (First Article Inspection) Responsibility - QC or Engineering? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q M-282 - Engineering Standard for Tolerances - Is it ASTM, DIN? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L Supplier Revision Confirmation of Received Engineering Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Document Control Guidelines in Engineering Projects - Excel sheets with VBA coding Document Control Systems, Procedures, Forms and Templates 3
A Software Suggestions for Engineering Change/QMS Design and Development of Products and Processes 2
M New MHRA guidance on Human Factors - Usability Engineering IEC 62366 - Medical Device Usability Engineering 1
S Process Map for an Engineering Consulting Firm Process Maps, Process Mapping and Turtle Diagrams 6
S Quality Measure for Engineering Services Misc. Quality Assurance and Business Systems Related Topics 1
G Senior Project for BS Mechanical Engineering Student Career and Occupation Discussions 4
L BSI White Paper on Human Factors/Usability Engineering IEC 62366 - Medical Device Usability Engineering 12
M More than canned audit check-sheets? Auditing the Engineering Department Process Audits and Layered Process Audits 5
A Remote Support Location Audit - Engineering prototyping and process evaluation Internal Auditing 2
M Engineering Release Process Owner Manufacturing and Related Processes 4

Similar threads

Top Bottom