Design Transfer to production = New product introduction ??

V

Velyn

#1
Hi Folks,

I needed some help here. My company is manufacturing Class ii medical devices and I was being task to write SOP or perhaps work instruction for design transfer to production (supply chain manufacturing).

Yet, I am getting confused when I was told to write about the procedure of design transfer to production which include New Product Introduction as well as initial production lot in manufacturing upon receiving all spec required from R&D (BOM, drawings, spec). In the same SOP/WI, CFR 820.70 (production and process controls) requirement must also be included. And finally, procedure about DMR is released to production.

I'm from engineering department and I don't really have in depth knowledge to write Quality related document especially regulatory topic like design transfer, DMR etc

Have anyone ever wrote such a SOP about design transfer, new product introduction and PnPC in one document...? Or should the topic be written in separate SOPs instead of one?

Any examples can share?

Thanks for the help.
 
Elsmar Forum Sponsor
J

Julie O

#2
My best recommendation to you is that, if you are not already actively seeking employment elsewhere, do so. However, since new jobs are rarely had at the snap of the fingers, here is some guidance to tide you over until you move on:

1) SOPs should describe how things are being done, not how they should be done.

2) The best people to "write" an SOP are the people who are doing the process to be documented in the SOP. These people don't necessarily have strong writing skills, so they may need some assistance with the actual writing, but they should be the source of the content. They should also be the drivers of the SOP development process.

3) "SOP" is singular. The process being documented should be singular too. One process = one SOP.

4) Start by defining the point at which the process (eg, design transfer) starts. Identify what has to have been done in order for you to be ready to start the process, and also anything you need (eg, documentation) to start the process.

5) Next, define the point at which the process is "completed." Identify the people that need to be notified of its completion, the documents that have been generated in the course of completing the process, and what needs to be done with those documents.

6) Then it's just a matter of filling in the steps in between.

7) Don't list the content or organization of files or other documents in your SOP. Develop documents titled "Organization and Content of..." or "Format and content of..." and reference them (or attachment them to) your SOP.

Good luck. I'm afraid you are going to need it.
 
V

Velyn

#3
:thanx: Julie for the guide. I would discuss with my dept about it that different processes/topics should be of separate doc and reference to each other where appropriate instead of jumble all together in one SOP.

Agreed with your point that one SOP should address one process in details on how it's being carried out (i.e design transfer, NPI, PnPC in separate doc)..

My thoughts is that FDA CFR820 requirement should probably be addressed in written QMS doc/policy and each process owner (i.e, engineering, manufacturing, purchasing etc) would prepare our own process SOP that compliance to regulatory requirement.

By the way, would you mind share with me on what made you think of recommending to seek new employment? Was it my role and responsibility doesn't comply with the task given? Speaking of that, would auditor ever question/fault a company about responsibility and ownership of quality assurance document which is written by other not from quality dept who may not have good knowledge for certain standard ie ISO13485, CFR820?

Again, thanks for your guide. I really appreciate it that I'm still learning to understand more about regulatory for medical devices manufacturing industry. :)
 
J

Julie O

#4
would you mind share with me on what made you think of recommending to seek new employment? Was it my role and responsibility doesn't comply with the task given?
Oh, it's mostly because I'm old and have seen too much of everything too many times before,. Yes, generally it does not sound to me like your company has the internal knowledge and resources it needs to support a good quality system. This doesn't necessarily distinguish it from many other companies out there, but I have learned that life is short and it's better not to spend too much of it beating your head against a wall that is unlikely to move.

I will be interested to hear their reaction to your recommendations. If they are accepted with enthusiasm and then promptly implemented, I will withdraw my suggestion.

would auditor ever question/fault a company about responsibility and ownership of quality assurance document which is written by other not from quality dept who may not have good knowledge
I think an auditor is unlikely to question the authorship if the document itself does what it needs to do. I think this is harder to achieve if the author does not have good knowledge of the subject matter.
 
V

Velyn

#5
I see :) understand your rational.

For my company perception is that author is the subject matter e.g. manufacturing processes, therefore my dept should own QM SOP eventhough the author may not fully understand iso/regulatory requirement. We do understand well about processes but not regulatory requirement i.e process validation requirement.

Yeah, it's hard to achieve for those who don't have the background.
 
Thread starter Similar threads Forum Replies Date
T Design Transfer & use of "prototype" components in production devices. ISO 13485:2016 - Medical Device Quality Management Systems 10
E Is Design Transfer to Production be complete prior to Release of first production lot 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Mfr. Process Validation BEFORE Design Transfer? Other Medical Device and Orthopedic Related Topics 1
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
D Design Transfer Template capturing Customer Specific Requirements Other Medical Device Related Standards 3
C Essential Design Output(s) and Design transfer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
C Design Transfer Review - Before or after PQ validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
C Design Transfer - How do you guys control the design transfer process? Document Control Systems, Procedures, Forms and Templates 5
Ajit Basrur Looking for a Design Transfer Checklist 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Design Transfer between two companies with different QMS CE Marking (Conformité Européene) / CB Scheme 3
P Responsibility for Design Transfer - OEM vs. CM ISO 13485:2016 - Medical Device Quality Management Systems 6
L Software Medical Device - 7.3.8 - Design and Development Transfer ISO 13485:2016 - Medical Device Quality Management Systems 4
U When does design transfer take place? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 30
T Design Transfer from R&D to Manufacturing for 21 CFR 820 Design and Development of Products and Processes 4
S 21 CFR Part 820.30(h) Design Transfer Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
R Design Transfer - any feedback from Medical Device Conference at MDM Minneapolis? Design and Development of Products and Processes 1
C Definition Design Transfer - New requirement of QSR 820 - What is Design Transfer? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
B Validation of design for valve api 6d 25 edition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
B Hi , everyone i need a procedure for validation of design prototype api 6d (valve manufacturing) Oil and Gas Industry Standards and Regulations 0
K Exclusion of 8.3 Design and Development for Design Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Recognised/reputable courses for ISO 13485 Section 7.3 (Design & Development)? Other ISO and International Standards and European Regulations 1
J Design/Development. Oil and Gas Industry Standards and Regulations 6
O Regarding design and development requirements for a medical device EU Medical Device Regulations 6
W Rights of Supplier in Design & Build WP Manufacturing and Related Processes 0
K ISO 13485 Design Requirement with respect to "component" manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 11
rob3027 ISO 13485 justification for design and development exclusion for medical packaging ISO 13485:2016 - Medical Device Quality Management Systems 18
K What constitutes design under 9001? Design and Development of Products and Processes 15
P Product Requirements Control during Design Changes Design and Development of Products and Processes 4
B Minitab factorial design regression equation center point term Manufacturing and Related Processes 1
J Design Input Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
P Self Certified Class 1 MDR 2017/745 Design Change CE Marking (Conformité Européene) / CB Scheme 2
N Design V&V courses Career and Occupation Discussions 11
B AS9100 Design Authority questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
K Process FMEA responsible For "Make to Design Parts" (Inhouse or Suppliers ?) FMEA and Control Plans 3
K CE design Certificate EU Medical Device Regulations 3
M ISO 13485 consultants and auditors with design oriented focus ISO 13485:2016 - Medical Device Quality Management Systems 7
Q What are Quality Requirements for Design? Quality Management System (QMS) Manuals 8
B Use of Statistical Techniques in Design Verification Design and Development of Products and Processes 18
X Design stage overview (Product specification) EU Medical Device Regulations 3
gohyl Fixture Setup Design Manufacturing and Related Processes 3
D IS0 13485 - Design perspective to regulatory requirement. ISO 13485:2016 - Medical Device Quality Management Systems 3
T Software item classification and Detailed Design IEC 62304 - Medical Device Software Life Cycle Processes 4
armani 7.1.5 and design and development of product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Sidney Vianna ISO 9001 News ISO 9001 Design Specification to be developed - May 2022 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C Design output vs acceptance criteria ISO 13485:2016 - Medical Device Quality Management Systems 8
M Design Control Procedure Medical Device and FDA Regulations and Standards News 4
lisap Design falling outside ISO scope Misc. Quality Assurance and Business Systems Related Topics 11
S Link Between Essential Performance Requirements and Essential Design Outputs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
G Calculating Ppk for Design Verification - Variable Sampling Design and Development of Products and Processes 15
G How many Design FMEAs do you have? FMEA and Control Plans 4

Similar threads

Top Bottom