Who should be the person to release product to customer

Al Rosen

Staff member
Super Moderator
#21
Al, as I mentioned earlier that the batch release by Quality Unit is mentioned in 21 CFR Part 211 and not from 21 CFR 820.80.

Given my background from Pharmaceuticals, I had set my systems based on 21 CFR Part 211 and hence the "Quality Release" :)
we're in the Medical Devices Forum. This is why people need to be careful when getting advice in a forum. Always verify from the primary source.
 
Elsmar Forum Sponsor

Ajit Basrur

Staff member
Admin
#22
we're in the Medical Devices Forum. This is why people need to be careful when getting advice in a forum. Always verify from the primary source.
I am definitely careful when giving advice in the forum. In this instance, when I suggested that Quality Unit should be releasing is not a "WRONG" information at all. If I review the procedures of many big medical device organizations, they also have medical devices released by the Quality Unit.

Since FDA is not clear, its upto the organization to decide who should be releasing.
 
J

JaneB

#23
Where does the word Quality appear in this?
Why would a specific 'quality' word need to appear? I can't see the rationale.

It's built in to the requirements that ensure that each production run, lot, or batch of finished devices meets acceptance criteria. And the requirements are set out in detail.
 
Last edited by a moderator:
J

JaneB

#25
Whay about the logistics Manager!
Production --> produced
QA --> Approved and kept QA pass in Warehouse
When receive confirmation from customer or Sales, he issue pickslip and related Document,
So said, I logistics manager who incharge!
What do you think?

:frust:
DRDDO
I think you are thinking too narrowly. Re. 'final product' you seem to be considering only the role who actually releases the boxes/packages whatever leaving the warehouse (although you do point out the other roles involved in getting them to warehouse).

Now, I may not be 100% clear on what you really mean by 'who is responsible for final release', but I sure as hell wouldn't accept any company that manufactured anything who believed that the warehouse/logistics manager responsible for 'final release' of product! Release for delivery/sales, sure. But WHO makes sure that the product actually meets all of the specified criteria? Because that ain't the logistics manager. (Or if by any chance it is, it shouldn't be).

You are right in that a number of roles are responsible for various things along the way. I suggest you focus on who does what through the process: specify each main role involved, where they inspect & what they inspect for, what records exist to show that, and against what criteria.
 
D

DRDDO

#26
I don't think this would qualify as "final release", but the distribution records are required, as well. Typically, final release is a process step at the end of production. Once the product is "released" from Manufacturing, it's "released for distribution". Final release could be performed by the line supervisor or a "final QC" station at the end of the line. It's a verification step that assures that the acceptance criteria was met and all of the required documentation is completed. Some prefer that this step is performed by the Quality department. I think that takes the responsibility for product quality away from Manufacturing and fosters the alienation of the intent of Quality in the organization, so I prefer to leave the onus on Manufacturing to demonstrate that the product meets the acceptance criteria and endorse its acceptance in the final release documentation.

If you are worried that Manufacturing will run a muck and just release any old product, you've probably hired the wrong manufacturing department.
I like your answer
:agree1:
DRDDO
 

Al Rosen

Staff member
Super Moderator
#27
I think you are thinking too narrowly. Re. 'final product' you seem to be considering only the role who actually releases the boxes/packages whatever leaving the warehouse (although you do point out the other roles involved in getting them to warehouse).

Now, I may not be 100% clear on what you really mean by 'who is responsible for final release', but I sure as hell wouldn't accept any company that manufactured anything who believed that the warehouse/logistics manager responsible for 'final release' of product! Release for delivery/sales, sure. But WHO makes sure that the product actually meets all of the specified criteria? Because that ain't the logistics manager. (Or if by any chance it is, it shouldn't be).

You are right in that a number of roles are responsible for various things along the way. I suggest you focus on who does what through the process: specify each main role involved, where they inspect & what they inspect for, what records exist to show that, and against what criteria.
If the company is small, people wear more than one hat.
 

Al Rosen

Staff member
Super Moderator
#29
I am definitely careful when giving advice in the forum. In this instance, when I suggested that Quality Unit should be releasing is not a "WRONG" information at all. If I review the procedures of many big medical device organizations, they also have medical devices released by the Quality Unit.

Since FDA is not clear, its upto the organization to decide who should be releasing.
You said
The FDA (Food Drug Administration) requires the release of bacthes from the Quality unit.
That is not a true statement for the because "Quality Control Unit" is not identified as such in the FDA Medical Device QSR 21cfr820. That is a term used in the Pharma Regs.
 

Al Rosen

Staff member
Super Moderator
#30
Why would a specific 'quality' word need to appear? I can't see the rationale.

It's built in to the requirements that ensure that each production run, lot, or batch of finished devices meets acceptance criteria. And the requirements are set out in detail.
The point that I was making was that the term Quality Control Unit is not mentioned in the Medical Device Regulation. It is specific to the Pharmaceutical Regs.
 
Thread starter Similar threads Forum Replies Date
Anerol C Where should I start as the person responsible for the calibration laboratory? General Measurement Device and Calibration Topics 7
Ajit Basrur Should the Protocol and Report be signed by the same person(s)? Qualification and Validation (including 21 CFR Part 11) 7
S FDA approval (Med Device) - Should we use Accredited Person or proceed on Our Own? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C Hopefully supply to GM - What should a small 4 person company do IATF 16949 - Automotive Quality Systems Standard 8
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Should I take an online course for a career in Occupational Health and Safety? Career and Occupation Discussions 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
K Should APQP/PPAP has its own section in a QM? Quality Management System (QMS) Manuals 1
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
S Which Sampling Plan(s) Should I Use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Master Samples - What should we be keeping? IATF 16949 - Automotive Quality Systems Standard 9
G Supplier delivered recent PPAP, should he deliver yearly layout inspection? IATF 16949 - Automotive Quality Systems Standard 4
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Capability Study - in the beginning of your career what should you have known about the tool Quality Tools, Improvement and Analysis 11
J Should Loading and Unloading be Included in Cycle Times? Lean in Manufacturing and Service Industries 14
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
G Should I perform Gage R&R only at the beginning of a new project? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
J On PFMEA for danger labels - Label always should be assigned severity 10 ? FMEA and Control Plans 3
H Who should be listed as the manufacturer/distributor on the box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 3
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5
M Should volume of sales be factored into risk probability assessments? ISO 14971 - Medical Device Risk Management 33
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
M Which incubation condition should be selected to recover both bacteria and fungus effectively Miscellaneous Environmental Standards and EMS Related Discussions 3
D Is there a specific location for PPE such as safety glass holders and glove dispensers should be mounted Occupational Health & Safety Management Standards 10
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
M Who should receive the bills from suppliers and vendors, account payable or procurement? Consultants and Consulting 4
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
S Companies that maintain your machine should be in ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Use of "Shall" versus "Should" in Procedures ISO 13485:2016 - Medical Device Quality Management Systems 26
D Class II medical device - When should a complaint be closed? Customer Complaints 6
Sidney Vianna IATF 16949 News Presentations from the latest IATF Stakeholder Event - Expectation that IATF 16949 certification should equate with product quality. Misguided? IATF 16949 - Automotive Quality Systems Standard 7
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Ed Panek Part 11 Self Certify Memo - What else should it cover? Qualification and Validation (including 21 CFR Part 11) 5
H Should I mention machine/Equipment password In SOP? Qualification and Validation (including 21 CFR Part 11) 4
D How long should we keep the spare parts available for our medical device, after we have stopped the production? ISO 13485:2016 - Medical Device Quality Management Systems 0
H Statistical Techniques Procedure - What should be included Document Control Systems, Procedures, Forms and Templates 4

Similar threads

Top Bottom