Design Control 4.4 - Design Engineering manager has no structured documentation

A

Andy Bassett

#11
Thanks for everyones contribution. I took my time replying becuase i wanted to wade through all the suggested info and cross-refernce it with my copy of the ISO Standard.

Actually i have to be honest and say i am still struggling, i think maybe i am blinded by my usual environment (Automotive Motosport).

4.4.1 I can accept that a design procedure needs to exist blah blah blah
4.4.2 I can accept that some sort of design and development planning needs to exist. Whatever ISO wants, i usually ask for a Project Plan (Although these inevitably turn out to be a design and production time-plan).
4.4.3 Organisational and Technical Interfaces - In my environment this is too variable to define, in the procedure i just list all the interfaces i can think of and put in a get-out clause like 'where necessary'.
4.4.4 Design Input - Seems simple enough, a description of what we are trying to design (Although some cynical colleagues did once define a design input as 'Car should be as fast as possible'. I cant help but sympathise with them sometimes).
4.4.5 Design output - IE a drawing, and it appears that this should be checked. Against normal drawing standards i can accept, against a design input i have a problem, in most of the examples that i have seen the design input is a product of an engineer or marketing managers fantasy, and the design input is difficult to write until after the finished product can be seen (Maybe i am just unlucky with the products that i work with).
4.4.6 Design Review - My experience of design review is that it is taking place on an almost contiuous unofficial level. All the people involved are shocked when they are asked to fix a date and discuss all the necessary components. The best i have ever been able to do is get a Head Engineer to sign-off that design of the final product is complete. If its Christmas i might actually get him to compare it with the design input.
4.4.7 Design Verification - Err i think i have already done this Mr Auditor. What is wanted here.?????????
4.4.8 Design Validation - Err what are we talking about here, could it possibly be testing the prototype. If so i have no problem. (Wouldnt it be nice if it said this more clearly in the standard)
4.4.9 Design Changes - No problem they have to be handled according to a consistent procedure.

Re-reading the above it seems my problem lies somewhere between 4.6, 4.7, 4.8. Fortunately the auditors must have the same problem, otherwise they wouldnt have approved so many of my companies (Or maybe it was that bottle of whisky....)

Marc
I have a couple of suggestions, during recent debates i have referred people to your site and told them to go through one of the threads.
It is a good sort of training. Do you think it is worthwhile to offer some sort of on-line training? ie i tell engineers to log on to a course for design review, they do some interactive training, answer a questionnaire and get an E Mail certificate. I suppose in some way it takes work away from the implementer/consultant, but it may also support him.

Although i suppose i am paid to interprete the standard, i know that i, and many of my customers can only relate to it through real-life examples. Is it worthwhile to set-up on your web-site 4 or 5 real-life examples for each element of ISO 9000? I dont mean the procedures themselves, as very often they are written in the same dry manner as the Standard itself.

Regards
------------------
Andy B
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#12
Although i suppose i am paid to interprete the standard, i know that i, and many of my customers can only relate to it through real-life examples. Is it worthwhile to set-up on your web-site 4 or 5 real-life examples for each element of ISO 9000?
I am more than willing to 'publish' some if someone wants to provide the material. There have been conversations here about on-line training and such. I'm not 'ready' to spend the time to put something like this together alone, but will collaborate if anyone is interested. If someone want to really get into it we could put something up here as a fee based 'course'. hey - I'm open to ideas.

Does anyone remember the somewhat recent thread where we were discussing on-line training?
 
Thread starter Similar threads Forum Replies Date
W Need for current design or process control FMEA and Control Plans 2
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
Q Relabeler for patent expired product - design control responsibilities? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Design Control - Ways of capturing inputs from manufacturing Other Medical Device Related Standards 5
M Medical Device Design Control Auditor Recommentations General Auditing Discussions 19
R Operator's manuals as prevention design control FMEA and Control Plans 2
S Design Control for Class I Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Defining Approvals Required for Design Control Documents ISO 13485:2016 - Medical Device Quality Management Systems 6
C Design Transfer - How do you guys control the design transfer process? Document Control Systems, Procedures, Forms and Templates 5
S Is Human Factor Testing required as part of Design Control Validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
W Design Control Assistance required ISO 14971 - Medical Device Risk Management 7
V For a Drug-Device Combination Product, 'Design Control' Process is triggered at? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Design Control - Can Validation be based on a limited/first Production Run ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Design Control for Relabeling and Repackaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
N Dual ISO 9001 (Manufacturing) and ISO 13485 (Design Control) for same product line ISO 13485:2016 - Medical Device Quality Management Systems 3
J Incoming Inspection Plans under Design Control (part of DMR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
V Design & Documentation of Control Systems and Procedures Document Control Systems, Procedures, Forms and Templates 11
C How to evaluate the Detection Ranking of a new Design Control FMEA and Control Plans 1
A Design Control Requirements: IDE exempt, NSR Device (Clinical Study) US Food and Drug Administration (FDA) 2
M Class II Medical Device Design Control Non Conformance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
I Content to be included or excluded in Design Control Meeting Minutes ISO 13485:2016 - Medical Device Quality Management Systems 4
H ISO 9001 Document Control Requirements - Design and Development Department Checklists Document Control Systems, Procedures, Forms and Templates 3
M QSR - Design Control on Existing Device not Designed following QSR 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
H Medical Device Design Control Requirements (820.30) on Existing Products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Internal Design Control Audit ISO 13485:2016 - Medical Device Quality Management Systems 5
E Better control of DHR (Design History Record) during processing Document Control Systems, Procedures, Forms and Templates 5
D Class I and Class II Medical Device Accessory Design Control Requirements US Food and Drug Administration (FDA) 3
G Understanding Identification of Design in QSR 21 CRF Part 820.30 Design Control (f) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Tracking Log for IP during Design Control Process Document Control Systems, Procedures, Forms and Templates 1
K 7.3.7 Control of Design & Development Changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
K Design Control - Parent Company is located in Australia 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S New Requirements for Design Control in AS9100 C AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
W Design History Verification Records Control and Approvals US Food and Drug Administration (FDA) 3
B Design Control and Release Manual plus a Quality Manual Quality Manager and Management Related Issues 13
K Design Control SOP - Streamlining with R&D Department ISO 13485:2016 - Medical Device Quality Management Systems 6
A R&D Design Control - Ideas to Improve the Quality of Drawings Design and Development of Products and Processes 7
H Design Control Requirement - Initial Distributor of a Class I Video Laryngoscope US Food and Drug Administration (FDA) 4
M ISO 17025 and Design/Process Control Requirements ISO 17025 related Discussions 2
bobdoering Myth or Mythunderstanding: Implications of the Economic Design of Control Charts Statistical Analysis Tools, Techniques and SPC 1
C At what stage does Design Control play a role in Medical Device Development ISO 13485:2016 - Medical Device Quality Management Systems 2
B Suggestions on how to control a Design Dossier? Document Control Systems, Procedures, Forms and Templates 2
T Request for a Design Control Procedure or Process Flow for HVAC Design Document Control Systems, Procedures, Forms and Templates 1
A Design/Change Control Procedure - How to cope with Changes during Development? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 26
J What things go in Design Control Documentation for a 510k of Class II Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Design Control & Rapid Prototyping - Medical Device Software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Declaration of Conformity to Design Control 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Declaration of Conformity to Design Control 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
A QSR (820.30 part e) Design Review and Design Control Responsibilities 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8

Similar threads

Top Bottom