Validation of Processes - What is meant by 7.5.6 (a) - Defined Criteria for Review

Philip B

Involved In Discussions
#1
I'm just writing a validation procedure. Fairly straightforward but I'm not entirely clear what is meant by 7.5.6 (a) defined criteria for review and approval of the processes?

Is this review and approval prior to or after validation?

Thanks
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Re: Validation of Processes - What is meant by 7.5.6 (a) defined criteria for review.

Philip.

Before you get on with the procedure, understanding the requirement of validation must be good with everyone across the team.
This review and approve is not about any document.

Its about your process criteria that you are up with validating. May be Temperature, Pressure, RPM, Voltage, Time, Hardness, ....
 

Philip B

Involved In Discussions
#3
Re: Validation of Processes - What is meant by 7.5.6 (a) defined criteria for review.

Philip.

Before you get on with the procedure, understanding the requirement of validation must be good with everyone across the team.
This review and approve is not about any document.

Its about your process criteria that you are up with validating. May be Temperature, Pressure, RPM, Voltage, Time, Hardness, ....
Thanks Somashekar; so, for example, in the case of packaging validation, the validation approach that we are taking (seal strength testing, ageing testing, transit testing etc) needs to be reviewed and approved before we begin actual validation?
 

shimonv

Trusted Information Resource
#4
Re: Validation of Processes - What is meant by 7.5.6 (a) - Defined Criteria for Revie

Hi Philip,
The criteria for review and approval of the processes needs to be defined prior to the execution of the protocol.
Otherwise it would be like shooting the arrow and then marking the target...

Cheers,
Shimon
 

Philip B

Involved In Discussions
#5
Re: Validation of Processes - What is meant by 7.5.6 (a) - Defined Criteria for Revie

Hi Philip,
The criteria for review and approval of the processes needs to be defined prior to the execution of the protocol.
Otherwise it would be like shooting the arrow and then marking the target...

Cheers,
Shimon
Thanks Shimon, but is the standard talking about the process itself (how we package devices) or the validation process (how we validate the packaging process)?
 

shimonv

Trusted Information Resource
#6
Re: Validation of Processes - What is meant by 7.5.6 (a) - Defined Criteria for Revie

The ISO 13485 standard describes the high level processes in a quality management system (the what..). It does not go into the details of implementation.

There are other standards that discuss specific processes in greater details. For example, ISO 14971 has a lot of information about the risk management process.

To my knowledge there is not standard that speaks on how to package a device or how to validate the packaging. But there are standards for testing packaging integrity. Your process should be robust enough so you can pass these tests successfully and consistently.

That standards are, for the most part, guidelines. It is up to you to do the implementation (the how...), and if you have a good example it makes it much easier.

Shimon

"Good artists copy, great artists steal." - Pablo Picasso
 
Last edited:

kreid

Involved In Discussions
#7
Re: Validation of Processes - What is meant by 7.5.6 (a) - Defined Criteria for Revie

The standard is talking about validating the (packaging) process and the process you use for that validation.

So you have to approve the validation protocol before using it and then validate the processes by using the protocol.

If that makes sense?!
 

Philip B

Involved In Discussions
#8
Re: Validation of Processes - What is meant by 7.5.6 (a) - Defined Criteria for Revie

The standard is talking about validating the (packaging) process and the process you use for that validation.

So you have to approve the validation protocol before using it and then validate the processes by using the protocol.

If that makes sense?!
Thanks Kreid, that makes perfect sense and is what we do anyway thankfully!
 
Thread starter Similar threads Forum Replies Date
M Is Validation of Plating Processes required and who is responsible? Qualification and Validation (including 21 CFR Part 11) 11
Stoic Manual soldering processes - 100% verifiable, or always requiring validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
T ISO 13485:2016 - Processes exempt from process validation ISO 13485:2016 - Medical Device Quality Management Systems 12
J ISO 13485 - 7.5.2 cleanliness , 6.4.2 validation of special processes, and 6.4.2 contamination ability to be exempt? ISO 13485:2016 - Medical Device Quality Management Systems 5
GoSpeedRacer Validation of Processes 7.5.6 - Do cosmetic welds need process validation? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Re-validation NCR - In which cases re-validation of processes is required Oil and Gas Industry Standards and Regulations 6
M AS9110C Clause 8.5.1.2 Validation and Control of Special Processes for Repair Station AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
W AS9100D Clause 8.5.1.2 Validation and Control of Special Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 37
D 7.5.2 Validation of Processes for Production and Service Provision AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
L Validation Processes of Production & Servicing - API Q1 clause 5.7.1.5 Oil and Gas Industry Standards and Regulations 2
A 7.5.2.1 Validation of Processes for Production and Service Provision IATF 16949 - Automotive Quality Systems Standard 7
I Bracketing for Validation - Processes that share some unitary operations Qualification and Validation (including 21 CFR Part 11) 4
D 7.5.2 Validation of Processes for Production and Service Provision - Distributor AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Y 7.5.2 Validation of Processes for Production and Service Provision Discussions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J ISO 9001 Clause 7.5.2 Validation of Processes - How to comply? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
M Looking for a simple procedure on section 7.5.2 for Validation of Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S ISO/TS 16949 - 7.5.2 - Validation of Processes And 7.5.2.1 All Processes IATF 16949 - Automotive Quality Systems Standard 1
E What are Validation Requirements for Vendor (Supplier) Processes Supplier Quality Assurance and other Supplier Issues 5
K Validation of Processes does not seem to apply - Scientific Research Company Design and Development of Products and Processes 1
H Excluding 7.5.2 - Validation of Processes for Production and Service Provision ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
S 7.5.2 Validation of Processes for Production and Service Provision AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 56
F External Storage of Data - ISO 9001 Clause 7.5.2 Validation of Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Validation of Special Processes - Are Casting and Forging Special Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
N Validation of Special Processes - N/A of ISO 13485 Clause 7.5.2 ISO 13485:2016 - Medical Device Quality Management Systems 12
B Validation of Processes for Production and Service Provision - 7.5.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Understanding AS9100 Clause 7.5.2 Validation of Processes for Production and Service AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Validation of Processes - Is Cl 7.5.2 applicable to bricktile firing in an oven? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
L Outsourcing "passivation" - Clause 7.5.2 Validation of Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Validation of processes for production for Test Equipment ISO 13485:2016 - Medical Device Quality Management Systems 9
O Format for Clause 7.5.2 (Validation of Processes) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
T Validation of processes 7.5.2 - We are a label printer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B Validation of processes for production & service provision - Service industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
S Validation Of Outsourced Special Processes under AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
V Validation & which processes are called special processes & why not all the processes Manufacturing and Related Processes 9
V Validation of Processes for Production and Service Provision Procedure Document Control Systems, Procedures, Forms and Templates 8
C Equipment, Software and Processes Validation for Medical Devices - 21CFR 820.75 (a) ISO 13485:2016 - Medical Device Quality Management Systems 35
R Validation of Processes for Production and Service Provision - Clause 7.5.2 IATF 16949 - Automotive Quality Systems Standard 4
L Validation of Processes - Plastic Injection Moulding - ISO 9001 Clause 7.5.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
K Validation of Processes - How do I address TS 16949 Sec. 7.5.2.1 IATF 16949 - Automotive Quality Systems Standard 30
L Validation of Processes - Resulting Output can not be Verified - Exclusion to 7.5.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
R Validation of Processes for Production - How are doing it? Clause 7.5.2 Reliability Analysis - Predictions, Testing and Standards 25
R Validation of outsourced processes - Calibration - How do we validate that? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
M Software Validation Processes - Telecommunications software Software Quality Assurance 10
A Validation of Processes - How to meet requirement of TS 16949 para. 7.5.2.1? IATF 16949 - Automotive Quality Systems Standard 12
M Examples for Clause 7.5.2 - Validation of processes for production and service ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
F Process Validation of 'Special Processes' - How do I? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Exclusion from Validation of Processes for Production and Service Provision? Service Industry Specific Topics 17
J 7.5.2.1 Validation of processes - supplemental requirement IATF 16949 - Automotive Quality Systems Standard 11
S How to cope with the validation of processes - Services Service Industry Specific Topics 6
apestate ISO 9001:2000 Clause 7.5.2 Validation of Processes - Level II Response ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15

Similar threads

Top Bottom