SBS - The best value in QMS software

Where does process validation fit within design & development?

J

joylc

#1
#1
I'm working on drafting a design control procedure that conforms to ISO 13485:2016, and I'm having difficulty figuring out how process & software validations (section 7.5.6) fit within design and development (section 7.3). Does anyone have any insight?

Thanks :confused:
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
Y

yodon

Staff member
Super Moderator
#2
#2
A few thoughts:

Most everyone uses software-based issue tracking systems. Those generally create electronic records that support the d/d process.

Verification may use test fixtures that have to be qualified and test methods that may need to be validated.

Both Verification and Validation may need some statistically sound techniques.
 
Jane_S

Jane_S

Starting to get Involved
#3
#3
Hello!
I don't have much experience on this matter yet, as I myself am working on a similar task at the moment, but the way I see process/software validation is the "transfer to production activity". When the initial risk assessment is finished you decide if there are any processes which have to be validated and perform a validation.

I may be wrong, but I'd be very interested to see how this discussion evolves further.
 
rob73

rob73

looking for answers
#4
#4
Device validation and process validation should be kept separate, make reference to 7.5.6 in the D & D procedure but do not try and encompass it all. I know it all seems a bit chicken and egg " but how can i validate the device if i have not validated the process" but, the aim of device validation is to ensure the DESIGN meets the intended specification/user needs/intended use etc. Once you have a design that works, you can design,verify and validate the process to make it.
I don't generally deal with software, but i would hazard a guess that software embedded in the device falls under 7.3, software used in manufacturing (cnc programs etc) would be in 7.5.6.
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#5
#5
rob73 said:
Device validation and process validation should be kept separate, make reference to 7.5.6 in the D & D procedure but do not try and encompass it all. I know it all seems a bit chicken and egg " but how can i validate the device if i have not validated the process" but, the aim of device validation is to ensure the DESIGN meets the intended specification/user needs/intended use etc. Once you have a design that works, you can design,verify and validate the process to make it.
I don't generally deal with software, but i would hazard a guess that software embedded in the device falls under 7.3, software used in manufacturing (cnc programs etc) would be in 7.5.6.
Click to expand...
Devices used in Design Validation must be from the commercial production process, or at least from a process closely representing it. Therefore I think that the process should be pretty much set-up before design validation begins, preferably validated if necessary. The exception might be a process that doesn't have to be validated (outputs can be subsequently verified in the product) but is being validated due to practical or economical reasons - in that case the Design Validation specimens can be 100% verified instead of the process being validated first.

I've seen the practice of combining the two. It's not required and indeed these are two separate topics, but it makes some sense. You run IQ, OQ & PQ and continue to validate the design on the same production run.

Cheers,
Ronen.
 
rob73

rob73

looking for answers
#6
#6
Ronen E said:
Devices used in Design Validation must be from the commercial production process, or at least from a process closely representing it.
Click to expand...
I totally agree, like i said it can be a bit of a chicken and egg situation, but if your design is not validated and proven to meet expectations, is there any point in validating the process that made it?
Using IQ, OQ & PQ during your validation is the way to go :agree1:
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#7
#7
rob73 said:
if your design is not validated and proven to meet expectations, is there any point in validating the process that made it?
Click to expand...
Yes, it's a bit of a bet, but if you got the user needs right and worked your (engineering) design input properly out of the identified user needs, and design verification is OK (lots of ifs :)) - it's a safe bet to a large extent.
 
J

joylc

#8
#8
Thanks everyone for the input. I was thinking along the same lines as some of your replies but then kept getting caught up in the chicken/egg debate with myself.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
D Where does FMEA fit in your ISO 14971 Risk Management process? ISO 14971 - Medical Device Risk Management 13
M Research and Development Process - Where does research end and development begin? Misc. Quality Assurance and Business Systems Related Topics 15
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
D Where does "as far as possible" stop? FMEA - EN 14971 ISO 14971 - Medical Device Risk Management 29
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
P Warning Letter 1999 - Where does the FDA make older warning letters available? US Food and Drug Administration (FDA) 4
M Where does our regulatory responsibility end? ISO 13485:2016 - Medical Device Quality Management Systems 11
K Where does the FDA post its various compliance dates? US Food and Drug Administration (FDA) 2
C Where does Quality Authority come from? Career and Occupation Discussions 4
Q When does the FDA deem something "where appropriate"? 21CFR820.30(g) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
M Where does Document Revision Control Start? Rev 0 or Rev 1 Document Control Systems, Procedures, Forms and Templates 19
D Where does the QMS (Quality Management System) fit in your organization? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q Where does 5S technique fit into ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Where does OEE (Overall Equipment Effectiveness) belong? Quality Tools, Improvement and Analysis 11
F Where does Contact begin for Biocompatability? EU Medical Device Regulations 5
somashekar Where does RoHS stuff get audited by CB's? Quality Manager and Management Related Issues 3
S IEC 60601-1 3rd Gap analysis template TO BUY - Does anyone know where? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Where does 20% Lot Qualification Rule Come from? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
G Customer Property Cl. 7.5.4 - Where does ISO 9001 stop and ISO 27001 start? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
R Where does the definition of ME (Medical Electrical) Equipment originate? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
J Quality Organization - Does it matter where it reports to? Other US Medical Device Regulations 13
I Where does it state Supplier Corrective Action is required? Supplier Quality Assurance and other Supplier Issues 5
J Where does Lean Six Sigma Originate? Six Sigma 5
G 12 or 13 Men - Where does the extra man come from? Brain Teasers and Puzzles 5
S Where does least significant digit come into play? Measurement Uncertainty (MU) 8
T Organizational Charts - Where does the Quality Assurance Manager fit in Quality Manager and Management Related Issues 30
T Does anyone know where I can view Bac5300 Various Other Specifications, Standards, and related Requirements 2
A Where does the Lean Manufacturing philosophy / tool set come from? Lean in Manufacturing and Service Industries 32
H Where does the 16949 number in TS16949 come from? ISO Numbering System IATF 16949 - Automotive Quality Systems Standard 1
Wes Bucey Where does your hospital rank on quality? Hospitals, Clinics & other Health Care Providers 20
J GMP CFR 21 Part 210 or 211 - Where does GMP address Document Control Document Control Systems, Procedures, Forms and Templates 6
A Where does one find the complete list of ISO standards? Book, Video, Blog and Web Site Reviews and Recommendations 1
D Does anyone know where to buy an instant read dosimeter? ISO 13485:2016 - Medical Device Quality Management Systems 10
C What is Money for? Where does Barter come into play? Coffee Break and Water Cooler Discussions 19
E Where Does One Get Customer Specific Requirements? Customer and Company Specific Requirements 26
CarolX Where does Quality begin? Philosophy, Gurus, Innovation and Evolution 36
M Attribute Charting - Where does Cp and Cpk come into the equation? Capability, Accuracy and Stability - Processes, Machines, etc. 5
K Where and How Does Marketing Fit In? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
L Does anyone know where I can get documentation for the PUMA method. General Measurement Device and Calibration Topics 1
E SOP or system Work Instruction? Controlled Document - Where does one draw the line? Document Control Systems, Procedures, Forms and Templates 5
D Number of Distinct Data Categories:nDC: Where does the constant 1.41 come from? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
S Does anyone know where Guide 25/Palcan Training is available? Training - Internal, External, Online and Distance Learning 1
R Internal audit schedules - Where does it say that I need an annual schedule? Internal Auditing 13
B When Travel is allowed - Where are you going? Travel - Hotels, Motels, Planes and Trains 1
G Where to buy Template / sample SCSMS Manual, checklist Supply Chain Security Management Systems 1
S Where do l get calibration standards to run a calibration lab? Other ISO and International Standards and European Regulations 2
C Where to draw the line for "sufficient evidence" to verify safety/performance of a device? CE Marking (Conformité Européene) / CB Scheme 2
L Where to place the what/when/how/who/where procedures in a multi-regulation AS9110C organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3

Similar threads

Top Bottom