Who should be the person to release product to customer

S

SteveK

#11
It is always a difficult area when an auditor has a strong opinion which differs from that of the client - or in the case of products being sold to multiple companies - other auditors. In these cases it is often useful to go back to the specification defining the requirements. With the 'new' answer, I would quite strongly question how the person in charge of a production department head could be considered to have the necessary degree of independence to authorise a final release, so I am with Ajit on this one. Do you know how experienced your auditor was in this field?
Alan,

The auditor (covering ISO 9001, ISO 13485 and MDD93/42/EC) was exceeding experienced – and was adamant he was correct. I think the ‘logic’ was that although Quality signed off the product i.e. it passed testing, met specification etc, the final checks involved – “did final paperwork (actual and electronic) match the original order?” In this case as I said, the head of production who initiated despatch to the customer was seen as final sign off. I have now made this point clear in a modified production job description and procedure.

Steve
 
Elsmar Forum Sponsor
C

Chris Ford

#12
It is always a difficult area when an auditor has a strong opinion which differs from that of the client - or in the case of products being sold to multiple companies - other auditors. In these cases it is often useful to go back to the specification defining the requirements. With the 'new' answer, I would quite strongly question how the person in charge of a production department head could be considered to have the necessary degree of independence to authorise a final release, so I am with Ajit on this one. Do you know how experienced your auditor was in this field?
I just don't agree with this. Most of the companies I've worked for had "Final QC" people reporting to QA and releasing product. They basically checked everything that was checked in previous in-line QC, made sure the documentation was complete, and signed off on the final release.

It was incredibly expensive.

I eliminated the Final QC role from the QA department, and gave the responsibility for final release to the department most fitted - manufacturing. They've already done their testing, and they're responsible for the release. It makes it very simple.

I know many "old school" QA folks out there are probably thinking that I'm absolutely out of my mind. I prefer very lean quality departments with Quality built into the business processes. I've hosted 10 government inspections by FDA, and this has never been a problem. The registrar auditors have never raised an issue with it, either.
 
D

DRDDO

#13
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
 

Ajit Basrur

Staff member
Admin
#14
Actually, the Quality System Regulation does not require a quality function to be responsible for final release of product. The requirements are generally the same as 13485.

21CFR820.80(d)Final acceptance activities. Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until:
(1) The activities required in the DMR are completed;
(2) the associated data and documentation is reviewed;
(3) the release is authorized by the signature of a designated individual(s); and
(4) the authorization is dated.
(e)Acceptance records. Each manufacturer shall document acceptance activities required by this part. These records shall include:
(1) The acceptance activities performed;
(2) the dates acceptance activities are performed;
(3) the results;
(4) the signature of the individual(s) conducting the acceptance activities; and
(5) where appropriate the equipment used. These records shall be part of the DHR.
Refer section F on "Quality Unit" which mentions of batch release by Quality.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070337.pdf
 
C

Chris Ford

#15
Ajit, that's a guidance document for the pharmaceutical industry, pertaining to 21 CFR 201 and 21 CFR 211. It doesn't apply to medical devices. I quoted the Quality System Regulation (21 CFR 820) which does apply to medical device manufacturers earlier. The following is quoted from ISO 13485:2003:

8.2.4 Monitoring and measurement of product
8.2.4.1 General requirements
The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1) and documented procedures (see 7.5.1.1).

Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product (see 4.2.4).

Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed.

Neither 21 CFR 820 - The Quality System Regulation, nor ISO 13485:2003 require a specific unit, department or individual at a medical device manufacturer to release product for distribution. There is no requirement that a separate function review and release product at all.

Utilizing a separate Quality function to release product - solely to review documentation, and some sort of final "inspection" perhaps - only perpetuates the separation of Quality from the business functions, in my opinion. The "QC Police" shouldn't need to be a stop-gate for distribution. The Manufacturing department is responsible for production, and should have the final word as to whether the final acceptance criteria is met.
 
Last edited by a moderator:
C

Chris Ford

#16
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 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.
 

Ajit Basrur

Staff member
Admin
#17
Hi Chris,

You could be right in that aspect, but I would always like to extrapolate the 21 CFR Part 211 statement to medical devices also :)
 
C

Chris Ford

#18
Hi Chris,

You could be right in that aspect, but I would always like to extrapolate the 21 CFR Part 211 statement to medical devices also :)
All I can say is I'm glad FDA doesn't do that! :lol:

Sometimes overkill is warranted, don't get me wrong. I've worked at a couple of companies that needed the "whip cracking QA nazi" running around, poking into everybody's business. But those are rare situations, and usually very temporary stop-gap measures. I've personally installed QA review requirements over multiple parts of the quality system while we were "slapping the system into shape" so to speak.

FDA simply expects that manufacturers will apply practical controls appropriate for the device. However, even in Class III environments, you still don't need a separate Quality function performing final release activities.

It's a preference, and in some companies a necessity, but not a requirement by the stated standards and regulations that apply to the manufacturer in this situation.
 

Al Rosen

Staff member
Super Moderator
#19
The FDA (Food Drug Administration) requires the release of bacthes from the Quality unit. :)
From 21CFR820.80
(d)Final acceptance activities. Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until:
(1) The activities required in the DMR are completed;
(2) the associated data and documentation is reviewed;
(3) the release is authorized by the signature of a designated individual(s); and
(4) the authorization is dated.
(e)Acceptance records. Each manufacturer shall document acceptance activities required by this part. These records shall include:
(1) The acceptance activities performed;
(2) the dates acceptance activities are performed;
(3) the results;
(4) the signature of the individual(s) conducting the acceptance activities; and
(5) where appropriate the equipment used. These records shall be part of the DHR.
Where does the word Quality appear in this?
 

Ajit Basrur

Staff member
Admin
#20
From 21CFR820.80Where does the word Quality appear in this?
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" :)
 
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