Validation of New Process Equipment - What are the ISO 9001 requirements?

Q

qualitycube

#1
What are the requirements, per ISO 9000, for the validation of new processing equipment? If you replace a piece of equipment with something equal to or better than the old one, is it enough to document that:
A. The equipment is properly installed per the manufacturer's instructions
B. That the guages and controllers are set to the recommended settings
C. That test material has been ran through the process and that the end
results are within stated parameters
Is there more that we are required to do per ISO?
 
Elsmar Forum Sponsor

Wes Bucey

Quite Involved in Discussions
#2
qualitycube said:
What are the requirements, per ISO 9000, for the validation of new processing equipment? If you replace a piece of equipment with something equal to or better than the old one, is it enough to document that:
A. The equipment is properly installed per the manufacturer's instructions
B. That the guages and controllers are set to the recommended settings
C. That test material has been ran through the process and that the end
results are within stated parameters
Is there more that we are required to do per ISO?
Welcome to the Cove!:bigwave:
Actually, none of those things are "shalls" under ISO9001:2000.
They are all good things to note under Section 6.3 Infrastructure. The method of documenting such things is NOT prescribed in the Standard.

This may seem difficult to accept, but ISO9001:2000 is not as much about documenting everything as the previous version (1994), but more about creating an efficient work environment for the benefit of the organization, its customers, and employees.

Thus said, it is enough that the organization is satisfied that its infrastructure meets its needs and those of its customers and continually evaluates its suitability as time and circumstances change.

In TS16949 (Automotive version of ISO9001:2000), customer requirements MAY dictate you document the new equipment in the manner you suggest, but that is beyond the requirements of ISO9001:2000.
 
G

GMAC16949

#3
May Need To Validate

There may be more to it than that Wes. It would depend on a definition of that particular new equipment. At 7.5.2 ISO does provide for "Validation of Processes..." and includes "...approval of equipment and qualification of personnel..." Of course this clause refers to specific equipment / processes; those where resulting output cannot be verified by subsequent monitoring or measurement.

We should also make note of the simple statement TS has at 7.5.2.1 "The requirements of 7.5.2 shall apply to all processes for production and service provision." I know the question deals with ISO but ISO is currently undergoing a revision. In the past the revisions made to ISO sere strikingly similar to already existent QS requirements. Who Knows?

But for the initial question, consider whether your equipment fits that definition provided at 7.5.2.
 

Caster

An Early Cover
Trusted Information Resource
#4
Why not shall

qualitycube said:
What are the requirements, per ISO 9000, for the validation of new processing equipment? If you replace a piece of equipment with something equal to or better than the old one, is it enough to document that:
A. The equipment is properly installed per the manufacturer's instructions
B. That the guages and controllers are set to the recommended settings
C. That test material has been ran through the process and that the end
results are within stated parameters
Is there more that we are required to do per ISO?
Hi Qcube

It sounds like you are already well on top of this.

We sometimes get so wrapped up in "lawyering" the shalls of ISO that we don't stop to think what it's all about.

As has been said TS16949 is heavy on validating process changes (including perhaps performing a complete new PPAP).

Why - cause the big 3 were sick of hearing "well, we didn't think that change was going to cause a problem" when their lines went down due to a part problem due to a "better piece of equipmet". So they demanded we make sure before we ship.

If you have done the ABC stated, you have already done due diligence, and protected both yourself and your customer...and you didn't have to be forced to by TS requirements. Good on you!
 

antoine.dias

Quite Involved in Discussions
#5
Validation of equipment

The A,B & C activities you have done are the right things to do, but the validation is not yet completed with that.

The base line of validation is that validation should prove that the equipment does what it is supposed to do ( that it achieves the planned results ).
IMO This should be in several areas like:

- Quality
- Quantity or capacity
- Safety
- Ergonomics
- Environment
- Availability
- Maintainability
- .....

Hope this helps.
Best regards and success!!

Antoine
 
Q

qualitygoddess - 2010

#6
qualitycube said:
What are the requirements, per ISO 9000, for the validation of new processing equipment? If you replace a piece of equipment with something equal to or better than the old one, is it enough to document that:
A. The equipment is properly installed per the manufacturer's instructions
B. That the guages and controllers are set to the recommended settings
C. That test material has been ran through the process and that the end
results are within stated parameters
Is there more that we are required to do per ISO?
What do you need to do in order to assure that the process is functioning as designed? I would worry more about that aspect of it, than if it meets ISO 9001 requirements. Any auditor doing a process audit is going to observe the equipment as it is used in your overall process, and determine from there if you have done the things that need to be done for the overall process as it relates to 9001.

Good luck. You seem to have it well under control,.
 
F

Frank34

#7
Validation

Some of the best information I have seen for vaildation is from GHTF. The process validation guidance from SG3 (Study Group 3) offers many suggestions on what should be checked in various situations. Additionally, the information is free to all.

www.ghtf.org
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
N Validation procedure, Major NC CAP - Equipment Validation process is not effective ISO 13485:2016 - Medical Device Quality Management Systems 5
M Process Validation and Qualification of Legacy Equipment ISO 13485:2016 - Medical Device Quality Management Systems 10
M Process Validation/Equipment Qualification - Class 1A (Sterile) Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 12
R Equipment Change or Process Change? Validation protocol for a planar freezer Misc. Quality Assurance and Business Systems Related Topics 3
I Periodic Review of Process and Equipment Validation Qualification and Validation (including 21 CFR Part 11) 4
M Seeking guidance documents for Non FDA Regulated Process Validation - New Equipment Statistical Analysis Tools, Techniques and SPC 3
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
R PCBA process validation Qualification and Validation (including 21 CFR Part 11) 2
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 6
A Validation of Forced Aeration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
G Devices from IQ, OQ or PQ process to be used for verification, validation and summative? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
B API Q1 5.7.1.5 Process Validation - Machining, heat treating, Manganese Phosphate and Zinc Plating Manufacturing and Related Processes 2
D ISO13485:2016 7.5.6 Process Validation Responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 1
Z Who is responsible for writing the validation of a new process? Manufacturing and Related Processes 7
M Requirement for manufacturing process validation in IATF 16949 IATF 16949 - Automotive Quality Systems Standard 8
E Sampling plan for orthopedic implant - Process Validation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
Z Class 2 medical device - Process Validation - Test sterile or non-sterile units? Qualification and Validation (including 21 CFR Part 11) 4
T ISO 13485:2016 - Processes exempt from process validation ISO 13485:2016 - Medical Device Quality Management Systems 12
L Injection Moulding Process (Special Process) Validation Food Safety - ISO 22000, HACCP (21 CFR 120) 2
K Is Mold qualification / process validation always required? Manufacturing and Related Processes 7
R Process Validation on CNC Lathe and Milling machining process Design and Development of Products and Processes 1
Q Release of the first batch of a cleared product before process validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Process Validation sample size selection Statistical Analysis Tools, Techniques and SPC 0
P Auditing "process validation" process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
E Cleaning Validation Process of Non-Sterile Implants and Instruments Other Medical Device Related Standards 2
W Design and Process Validation - Different? ISO 13485:2016 - Medical Device Quality Management Systems 6
A Supplier - Process Validation Manufacturing and Related Processes 3
M Medical Device Process validation, Validation of excel spreadsheets used for process Other Medical Device and Orthopedic Related Topics 4
V Tyvek packaging for Medical device process validation Qualification and Validation (including 21 CFR Part 11) 2
L Process Definition and Process Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Can we sell units that were chosen for process validation? ISO 13485:2016 - Medical Device Quality Management Systems 6
S How do I do a Process Validation for soldering process Manufacturing and Related Processes 5
S Process validation when changing location ISO 13485:2016 - Medical Device Quality Management Systems 10
A Process Validation of QMS Software ISO 13485: 2016 Cl. 4.1.6 ISO 13485:2016 - Medical Device Quality Management Systems 26
P Root Cause for a Process Validation Batch Failure 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
GoSpeedRacer Validation of Processes 7.5.6 - Do cosmetic welds need process validation? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Is Aeration Process in ETO Sterilization Validation Required? Manufacturing and Related Processes 7
C Does Japan accept the Bracketing Approach for Process Validation Japan Medical Device Regulations 1
A Robotic Sanding and Painting Process Validation Manufacturing and Related Processes 5
alonFAI Gamma Irradiation Process Validation Help Other Medical Device Related Standards 2
J Where does process validation fit within design & development? Design and Development of Products and Processes 7
O Process Mapping prior to Validation and Software to use to Map Process Maps, Process Mapping and Turtle Diagrams 12
M Justification for Not Having a Validation Plan for a Critical Process ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom