Cost Targets as Design Inputs in your DHF (Design History File)

S

sshankle

#1
Do you guys put cost targets as design inputs in your DHF, some other place, or use them at all?

Thanks!:thanx:
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#2
Re: Cost Target as Design Input

I am sorry, it is the end of my work day so my brain feels a little soft... what is DHF please?
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#4
The FDA, in its document Design Control Guidance For Medical Device Manufacturers describes cost as a consequence, as in cost of poor quality, and doesn't include cost targets among inputs (see section C).

But if you wanted to include a file or referencing a study showing cost savings curves by reducing inefficiencies or errors, I would think that could be part of the review. In order to shorten the time-to-market cycle and/or reduce costs of inefficiency/error, the "Check" stage of every project should include performance of the project, but many times this stage just addresses the item or service being designed.
:2cents:
 

Ronen E

Problem Solver
Moderator
#5
Do you guys put cost targets as design inputs in your DHF, some other place, or use them at all?

Thanks!:thanx:
If you refer to unit cost - then definitely yes, it is a design input. For instance, if you try to design a disposable device that costs to make $0.1, the resulting design will be very different from one corresponding with a $1 unit.
 
#6
Sorry to resurrect an old thread, but I am in this position at the moment and figured adding to this was more beneficial than starting a new thread.

Having a CoGs requirement definitely educates your design, however the other consequence of this is that if it is in a user or system requirement, per the FDA, you need to either validate or verify this requirement. It feels like there should be a "business needs" document that is separate for these types of requirements. Is this a common practice in organizations? Or do people just ignore the requirement in their V&V stages?
 

chris1price

Trusted Information Resource
#7
I have put cost of goods into the Design Inputs and adding up front that we will verify it by generating a bill of materials and estimated assembly cost. Confirmation of the actual costs were entered later. As long as we were not trying to be too precise in the original cost requirements, no one saw a problem with this.
 

William55401

Quite Involved in Discussions
#8
Cost is important to the business but outside the scope of QSR. I would not include them in your DHF as they become visible to regulators. Mature orgs manage cost carefully but establish a clear boundary of what's in (DHF) and what's out (cost, for example) of the documented scope of the QMS. I have been at industry forums where FDA indicated they have asked for this sort of information in the cases where the device manufacturer included it in scope of Design Controls.
 
Last edited:
Thread starter Similar threads Forum Replies Date
S Manufacturing process design inputs - Productivity, process capability, cost targets Design and Development of Products and Processes 2
CaliperJim Cost of Quality calculation Quality Tools, Improvement and Analysis 4
A AS9100D new certification cost?? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J COST OF POOR QUALITY IATF 16949 - Automotive Quality Systems Standard 5
marmotte MDD legacy until 2024 - EUDAMED, role (and cost!) of the EC Rep EU Medical Device Regulations 6
R Cost per test tool/formula Oil and Gas Industry Standards and Regulations 1
R Cost per test tool/formula Oil and Gas Industry Standards and Regulations 1
N Guidance - Cost of Good Quality Misc. Quality Assurance and Business Systems Related Topics 2
C Budgetary cost to obtain ASME NQA-1 Quality Program Certification Quality Management System (QMS) Manuals 0
C ISO 19227 Validation Cost Other Medical Device Related Standards 2
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
B Lowest cost way to pass Lead Auditor exam ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
optomist1 Automotive News The Cost of Inspecting In Quality IATF 16949 - Automotive Quality Systems Standard 7
S IEC 62304 - Software verification cost IEC 62304 - Medical Device Software Life Cycle Processes 3
S Cost of Poor Quality (CoPQ) - Scrap element of calculation includes lost margin? Misc. Quality Assurance and Business Systems Related Topics 7
michellemmm What is the Cost of six sigma certification? Six Sigma 10
B Include cost of quality (and other wastes) in an ISO 9001 system? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
F FDA-registration and inspection cost 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Estimated cost for MDR certification Other Medical Device Regulations World-Wide 8
I Reducing CE marking cost using manufacturer test reports CE Marking (Conformité Européene) / CB Scheme 5
E How much a bioequivalence study will cost in the UK Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
A Cost effective thread gaging with ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
JoCam Medical Device Recalls - Manufacturer's obligation for covering cost EU Medical Device Regulations 17
N European Authorised Representative (also called Authorized Representative) - Cost competitive recommendation EU Medical Device Regulations 1
G When preventative action is prohibited by cost in 8D problem solving Problem Solving, Root Cause Fault and Failure Analysis 1
G When preventative action is prohibited by cost in 8D problem solving Problem Solving, Root Cause Fault and Failure Analysis 8
T MDSAP AO Cost ISO 13485:2016 - Medical Device Quality Management Systems 2
M What is a reasonable MDSAP cost? ISO 13485:2016 - Medical Device Quality Management Systems 9
B Warranty costs - What is your definition of a "warranty cost"? Nonconformance and Corrective Action 1
N Where I can find an Excel sample/template for recording Delivery Time and Cost Excel .xls Spreadsheet Templates and Tools 2
N Establishing a monthly scrap cost target Lean in Manufacturing and Service Industries 11
S Handling Cost of Sales requests for Customer Quality Manager and Management Related Issues 2
S MDSAP cost per jurisdiction ISO 13485:2016 - Medical Device Quality Management Systems 11
K RAPS RAC - Resources to prep for the RAC exam that don't cost an arm and a leg Professional Certifications and Degrees 3
C What is your Cost of Poor Quality (COPQ)? Misc. Quality Assurance and Business Systems Related Topics 8
I How much does an eQMS (Electronic/Software QMS) cost? Quality Assurance and Compliance Software Tools and Solutions 1
F Cost of hiring ISO 17025 Consultant to Build Laboratory From Scratch ISO 17025 related Discussions 6
S Gage Block Verification or buy a new set (cost aspect) General Measurement Device and Calibration Topics 1
A Cost of Deviating Away From PPAP Requirements APQP and PPAP 3
N What is the Cost of Tracking Non-Conforming Product Nonconformance and Corrective Action 5
B Cost to a dealer for a "Declaration of Conformity " "Gost-R" in Ukraine? EU Medical Device Regulations 2
W How much would it cost to setup a Quality System for a Repackager or Relabeler? Quality Manager and Management Related Issues 1
JoCam Cost of maintaining CE Mark Regulatory Approval Other Medical Device Regulations World-Wide 3
S Cost of DMF Type III preparation and submission Other US Medical Device Regulations 1
R Looking for good, low cost APQP Software recommendations APQP and PPAP 2
Marc The Cost of Living - 1938 in the US Coffee Break and Water Cooler Discussions 11
B Machine Shop Yield and Cost - Productivity, Yield and Absorption Performance Manufacturing and Related Processes 3
M Reducing Cost of Poor Quality - Your opinion requested Quality Manager and Management Related Issues 14
L OEE (Overall Equipment Effectiveness) and Cost Savings Manufacturing and Related Processes 2
Wes Bucey A "Feel Good" story - 3D Printing Creates Low-Cost Prosthetic Fingers Coffee Break and Water Cooler Discussions 0

Similar threads

Top Bottom