FDA QSR Inconsistency? Design Validation

M

madannc

#11
Re: FDA QSR Inconsistency?

reminded of an old adage reading this:

Verification - Did we make the thing right?

Validation - Did we make the right thing?

Ultimately I keep thinking about design inputs, we need to remember that these are not solely customer requirements.

Would an inspector not be concerned with Design Inputs as just an entity, you as a company may well perform QFD, Kano and a myriad of other tools to determine customer needs but at the end of the day, you have a set of design inputs that need to be need to be converted to a realised and manufactured device following 21CFR820.

Whether or not you invested time to determine the market requirements is a business decision, as presumably you would want to sell the device.

The FDA will be concerned that the design effort shows that the inputs and output match, and of course that Design Controls are in place.

If the device meets FDA requirements it will get clearance, if however it does not meet a market need, clearance or not it will not sell.

:2cents:
 
Elsmar Forum Sponsor
W

Watchwait

#12
Re: FDA QSR Inconsistency?

Watchwait
You say that you company HOPES to meet the user needs, and that you THINK that you built what the customer wanted.
How does your company base its design criteria? Does it use customer feedback on existing product, do you use BETA products for the customer to use?
How do you know that you are not developing a product that is used opposite of what other similar products on the market are?
How does your company INTERPRET the customer needs?


Phil
Great questions! Yes, we use customer feedback on existing designs and from controlled "beta" releases. We also take into consideration customers' comments on other, competitive products. The "interpretation" of customer needs is essentially the Marketing group speaking to the Engineering group about what they feel are true customer needs. As this IS one essential function of Marketing, this seems altogether appropriate. Also, as in any organization , this interpretation process is as subjective as it is objective.

Consequently, the need to confirm that Marketing has indeed correctly interpretated user (customer) requirements by nature necessitates re-visiting the customer and asking the question: "Here is what I think you want. Is this correct?" The process of asking this question & responding to the answer is, in essence, Design Validation in its purest form. It seems the only way to truely answer the pertinent question: Did we build the right product.
 
W

Watchwait

#13
Re: FDA QSR Inconsistency?

This discussion has been on going at my company for a while, management is of the opinion that testing of the device to performance standards is design validation. When I contacted the FDA for clarification I got the standard reply " it is up to the manufacturer to determine how they meet the design validation requirement" It would seem to me ideally simulated or actual use by end the end user would be nice, but real world this could have significant cost impacts.
I feel your pain. What you described is, by definition Design Verification. In terms of the FDA response you received, it is altogether correct as well. Too, the clarity of the response speaks volumes about the real issue: you have to perform Design Validation. It is NOT an optional excercise and Design Verification is not, by itself adequate to meet FDA requirements. Many a company has found this to be the case. In my experience, I would much prefer to have a "discussion" with the agency regarding the adequacy of my validation efforts as opposed to the absence of those efforts altogether.

It may also be helpful to recall that Design Validation can be performed in real-world, or "simulated" environments. I have seen many firms who consistently use in-house staff to perform design validation. You just need to select the right folks to do it. For example, if you are manufacturing a headset you don't want the design engineers performing the design validation! Give it to a bunch of Administrative Assistants, let them try it out & document their comments. This approach is more than adequate and will typically be the least burdensome approach.

Conversely, if your customer/user group is a "technical professional", e.g. a physician needing to assess the design adequacy of a new piece of diagnostic software, you likely need to do that with a physician as opposed to someone in-house who *thinks* they know how a physician would react. These are the types of judgement calls your company must make regarding Design Validation & they must be supported with a written rationale that can be defended. Personally, I always imagine myself stitting across from an FDA inspector having these types of discussions. That imagery always lends clarity to my thinking!
 
D

danpa

#14
Re: FDA QSR Inconsistency?

Watchwait,
21CFR, Part 820, para 820.30(g) defines Design Validation as follows: "Design Validation....Design validation shall ensure that devices conform to defined used needs and intended uses..."
para 820.30(c) says: "Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient."

Design input defines the users needs. Part of validation is ensuring that the design inputs fulfill the users needs. This is often done by having knowledgable folks review and approve the design input and requirements documents. Then the validation testing is confirming that those design inputs have been satisfied.

As per the internal aurgument, just remember that 21CFR is the regulation and must be followed. If guidance is different than the regulation, the regulation wins.
 
W

Watchwait

#15
Re: FDA QSR Inconsistency?

Following this logic, design validation would then consist of confirming that design output met "defined user needs". In order to be "defined" they need to first be assessed, interpreted and documented - typically the job of Marketing. So...using the 21 CFR requirement, this process would only assess what was produced versus what marketing "defined" as the customer need.

Conversely, the guidance doc excludes the word "defined" and specifically states "user needs". The only way to assess this is to go back to the real (or simulated) user and compare what they (the user) wanted vs. what Marketing (et.al) said (e.g. defined) they needed;

There is a HUGE difference in these two approaches: Only the later accomplishes the true FDA objective of validation. IMHO, too many organizations try to "argue" that the first approach is adequate - typically out of cost cost/resource concerns. Big mistake.
 
D

danpa

#16
Re: FDA QSR Inconsistency?

Watchwait,
I will agree that user input and user testing is critical to a quality product, but that input/testing does not have to be part of my Validation that is done on production or simulated production product.
The user should be involved throughout the development process "validating" that what is being built is the correct product. But in some cases, the user will have to be represented by someone in-house, such as marketing (user may not want to be involved in development processes:(, user community is very large and diverse, etc.)
 
P

Phil Fields

#17
Re: FDA QSR Inconsistency?

This quote is taken from "The Quality system Compendium, GMP requirements & Industry Practices", which is a discussion point from the FDA (820.20).

“The validation test also should address use by intended users, as the actual use of the device does not directly coincide with that envisioned by the designers. Users may attempt to use the device in ways that were not anticipated during the development process. Stress testing by those unfamiliar with the design is a valuable technique of identifying potential error conditions.”

Phil
 
W

Watchwait

#18
Re: FDA QSR Inconsistency?

I believe the key here is to have the wisdom and knowledge to determine when a "real world" vs. a "simulated user" validation is appropriate. In essence, the true purpose of validation is to determine if the company has correctly assessed, interpreted and implemented user needs. It then follows that asking "the Company" if they correctly interpreted user needs would be like asking Marketing if they did their job correctly. In terms of a user not wanting to be involved in product development: true enough. However I know of no user who would who would take offense at being asked: "Is this the product you wanted? I think it is, but I need you to confirm this".
 
Thread starter Similar threads Forum Replies Date
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
Marc Problem with 21 CFR Part 820 - US FDA Quality System Regulations (QSR) sub-forum link - 2 May 2019 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
D FDA QSR task checklist based on inspection citations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B Classes/ Online Training on ISO 13485:2016 and FDA QSR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 5
Y ISO 13485:2003 &FDA QSR (21 CFR 820) Quality Manual,34 Procedures and Form Book, Video, Blog and Web Site Reviews and Recommendations 8
P FDA QSR Inspection Consultant Recommendations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
I Recording of In Process Data to Meet FDA QSR 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Can I approve my own Documentation per FDA QSR 21 CFR Part 820? ISO 13485:2016 - Medical Device Quality Management Systems 1
A How many processes for an FDA Quality System (QSR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
P What's the difference between ISO13485 and FDA/QSR? ISO 13485:2016 - Medical Device Quality Management Systems 16
A Does any one have FDA 21 CFR Part 820 QSR training material? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
Q How Demings Point 9 (of his 14 points) is related to the FDA QSR Quality Tools, Improvement and Analysis 3
M ISO 13485 and FDA QSR Employee Training Requirements when Procedures are Revised Manufacturing and Related Processes 5
B FDA QSR Data Analysis & Trending Requirements US Food and Drug Administration (FDA) 5
W Injection Molding Validation Required or Not - FDA QSR 820.75 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
A Purchasing Information Requirements - ISO 13485 Clause 7.4.2 and FDA QSR Supplier Quality Assurance and other Supplier Issues 2
Q ISO 13485, FDA's QSR, CMDR, MDD: Seeking Internal Audit Correlation Matrix Various Other Specifications, Standards, and related Requirements 3
S FDA 21 CFR 820 QSR Quality Manual example wanted 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M FDA QSR Requirements - Checklist for Class II Medical Device Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Questions about the "change control procedure" in FDA's QSR manual 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T What would the FDA expect to see when they ask for our QSR? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 20
D Administrative personnel training - ISO 13485 and FDA QSR requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
GStough FDA QSR (Quality System Regulation) Training Needed in the Southeastern USA Training - Internal, External, Online and Distance Learning 7
H Sample Design Plan that complies with FDA QSR, ISO 13485 & 14971. ISO 14971 - Medical Device Risk Management 5
A Re-manufactured vs. Refurbished under FDA QSR ISO 13485:2016 - Medical Device Quality Management Systems 2
C Software recommendations for CAPA that will meet the FDA QSR & Part 11 Quality Assurance and Compliance Software Tools and Solutions 4
Q FDA Quality Plan - What kind of quality plan is required for FDA QSR? ISO 13485:2016 - Medical Device Quality Management Systems 2
F How do I ensure QSR compliance in an FDA company within 12 months ISO 13485:2016 - Medical Device Quality Management Systems 33
D ISO 13485, FDA's QSR, CMDR, MDD: Seeking Correlation Matrix ISO 13485:2016 - Medical Device Quality Management Systems 42
C Document Change Order - DCO templete which complies with FDA QSR requirements? ISO 13485:2016 - Medical Device Quality Management Systems 0
C Rework Requirements - ISO13485 Part 8.3 vs. FDA QSR ISO 13485:2016 - Medical Device Quality Management Systems 9
Q FDA Establishment Registration - Does registration require compliance to the QSR? ISO 13485:2016 - Medical Device Quality Management Systems 8
Q Looking for Best ISO 13485/FDA QSR Quality System Development Software Quality Assurance and Compliance Software Tools and Solutions 4
J ISO 13485 vs. FDA QSR (21 CFR Part 820) - Differences - Includes Spreadsheets ISO 13485:2016 - Medical Device Quality Management Systems 64
K ISO 9001, FDA QSR GMP Cross Reference Matrix ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
M What MUST be signed and dated? FDA QSR requires signatures for specific sections ISO 13485:2016 - Medical Device Quality Management Systems 4
Marc FDA has auditing guidelines posted on it's web pages for QSR ISO 13485:2016 - Medical Device Quality Management Systems 3
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
D FDA Information - Revising the Instructions for Use US Food and Drug Administration (FDA) 0
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
P MSDS for MVQ FDA White, Vinyl Methyl Silicone Rubber EU Medical Device Regulations 4
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
E FDA 513(g) Cover Letter US Food and Drug Administration (FDA) 5
S Records - Do's and don't' of record entries (FDA - 21 CFR 820) Records and Data - Quality, Legal and Other Evidence 13

Similar threads

Top Bottom