ISO 9001:2000 Clause 7.5.2 Validation of Processes - Level II Response

apestate

Quite Involved in Discussions
#1
I'm not sure how to read this requirement, at all. I struggle with the following sentence under:
7.5.2 Validation of processes for production and service provision

"The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement."

If I make widgets with Widgetmakers and control my production and service provision in 7.5.1, I wonder what output cannot be verified by subsequent monitoring and measurement.

my imagination becomes too active when I read a. b. c. d. e. requirements, because I cannot think of any processes where deficiencies should become apparent only after the product is delivered, or any output of production & service that cannot be verified by monitoring or measurement.

I think of 7.5 as my little factory, and it is a central point in the midst of the long string of the ISO 9001 requirements. everything feeds into it, hahaha. like a cartoon for the auditor, a fake process map.

can someone please explain 7.5.2 briefly in terms of application to a small hardware manufacturer on quote contracts? I can think of nothing!

Also, is it wrong to type out sections of the standard on this board when I'm asking questions like this?
 
Elsmar Forum Sponsor

CarolX

Super Moderator
Super Moderator
#2
atetsade said:
"The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement."

can someone please explain 7.5.2 briefly in terms of application to a small hardware manufacturer on quote contracts? I can think of nothing!
Is your hardware heat treated, is it plated? How do you verify this features? Certain process can only be controlled and verified by strict monitoring of the process.

Hope this helps clear it up a bit.

CarolX
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#3
Here's an example - I used to work at a place that bonded friction material to steel cores and bands. (transmission and brake parts). The way they verified the bond was to bend the pieces over a mandrel and then try to peel off the friction material. We did destructive bond testing 2X per shift, and in the interim we monitored process parameters that had been established during R&D of the process. Oven or platten temperature, pressure, cycle time, and viscosity of the adhesive were some of the process parameters monitored for product that could only be verified by destructive testing.
 
Last edited:

apestate

Quite Involved in Discussions
#4
Carol:

None of our product realization practices can ONLY be verified by close monitoring of the process.

All heat treating, plating, oxidation or other such process processing is done by approved suppliers. They provide certificates of conformance. If I start to re-check their work, will I stop before I do the metallurgy on the steel coming in from the mills?

The only thing I can reasonably say is not verified by subsequent monitoring or measurement is shipping. 7.5 goes through release & delivery activities, so I could have JUST ONE THING for 7.5.2. Ship a box of parts to Chicago and back to see if they get dinged up?

Is 7.5.2 ever a possible exclusion, and in what sort of manufacturing would it be excludeable.. excludable.. ex.. to leave it out?
 

Wes Bucey

Quite Involved in Discussions
#5
in-process validation versus after-the-fact

atetsade said:
Carol:

None of our product realization practices can ONLY be verified by close monitoring of the process.

All heat treating, plating, oxidation or other such process processing is done by approved suppliers. They provide certificates of conformance. If I start to re-check their work, will I stop before I do the metallurgy on the steel coming in from the mills?

The only thing I can reasonably say is not verified by subsequent monitoring or measurement is shipping. 7.5 goes through release & delivery activities, so I could have JUST ONE THING for 7.5.2. Ship a box of parts to Chicago and back to see if they get dinged up?

Is 7.5.2 ever a possible exclusion, and in what sort of manufacturing would it be excludeable.. excludable.. ex.. to leave it out?
As Carol says, this is not mysterious, just plain old everyday stuff.
Imagine your process produces a sealed "black box" with lots of little 'things' inside. Once the box is sealed (the output), you can NOT validate the number of 'things' or whether they are correctly fastened/connected. Therefore, you validate various aspects while the black box is in process, BEFORE it is sealed.

Given that kind of scenario, I'm sure you can imagine many other equivalents to a "black box."
 

howste

Thaumaturge
Super Moderator
#6
I don't agree with the "black box" approach in many cases. If I verify that the number of "things" is correct and properly fastened/connected before I seal the box, then it still doesn't fall under 7.5.2.

The processes that really need to be validated are ones that you can't verify the outcome after the process is finished (not the entire assembly). Without destructive testing, can you verify the strength of a resistance weld after it is completed? Heat treating, plating, etc. that Atetsade mentioned above would probably be candidates if they were done in-house. Of course, don't forget to include controls for the outsourced processes.

My experience has been that it's possible to exclude 7.5.2 in many companies with various products. Most I've seen don't exclude it though, preferring to include a contingency plan in case a new process is developed that requires it.
 
R

Randy Stewart

#7
howste said:
Without destructive testing, can you verify the strength of a resistance weld after it is completed?
Hit the nail on the head with that one.
As for the "black box", if it works you validated the process. With welding one way you can do this is by the welding heirachy.
Weld coupons (most frequent - tip changes, pressure changes, etc.) validate pull tests frequency
Pull Tests (medium frequency - x amount of parts, etc.) validate tear down frequency
Tear Downs (least frequent - set-up and end of run) verifies the overall process
 

CarolX

Super Moderator
Super Moderator
#8
atetsade said:
All heat treating, plating, oxidation or other such process processing is done by approved suppliers. They provide certificates of conformance. If I start to re-check their work, will I stop before I do the metallurgy on the steel coming in from the mills?
All the spec says is you have to validate in some manner. You utilize approved suppliers for your special process. You have some method for approval of these suppliers, and the provide you with a CoC. I would say you have covered the requirements.

JMHO,
CarolX
 
R

Rachel

#9
Okay, so on a similar line...

Hi everyone...
So I'm struggling with this one too. Ideally, in a perfect world, everything would fall to process validation over production control...for the sake of catching problems at the earliest possible time, minimizing rework, so on, so on, blahblahblah. I don't know what I'm getting at here...

I guess the question is this: is a destructive test still considered product testing, or is that process testing? I mean, you obviously can't destructively test *all* pieces...but then, you don't necessarily test *all* pieces anyway. I'm just having a hard time thinking of an example where there is no way (destructive or otherwise) to verify the output of a process.

Can anyone shed some light? It's pretty dark in my world. :confused:

Cheers all,
-R.
 
R

Randy Stewart

#10
You can do it

Rachel,
You need to define what the testing is trying to do. Here's an example with welding:

The tear-down tests are used to validate the process.
The pull tests are used to validate the tear-downs and on-going performance,
the weld coupons are then used to validate the setups.

Another way would be:

Weld coupons show you can set the process up properly,
the pull test show that you can operate within process parameters,
and the tear downs show that you have a compliant process.

Does that help?
 
Thread starter Similar threads Forum Replies Date
R Key Process Indicators (KPIs) for ISO 9001:2000-certified Service Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P Internal Audit for ISO 9001:2000 vs. Internal Audit for OHSAS 18001:2007 Internal Auditing 4
H ISO 9001:2000 Certificate - Original approval date 18 July 1995 and valid until 2012 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
E ISO 9001:2000 transition to ISO 9001:2008 - Do I have to rewrite the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
M Advantage between ISO 9001:2000 vs ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A Quitting ISO 9001:2000 - Necessary Changes to product literature, logos, etc. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
M Updating a Quality Manual from ISO 9001:2000 to ISO 9001:2008 Quality Management System (QMS) Manuals 57
B Updating from ISO 9001:2000 to ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Advice needed for ISO 9001:2000 update to 2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
K How to update from Procedure to Process - ISO 9001:2000 to ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
F How much longer can a company declare registration to ISO 9001:2000? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
N ISO 9001: 2000 to ISO 9001: 2008 - How to change the documents & procedures? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Transition from ISO 9001:2000 to ISO 9001:2008 and TS 16949:2002 to TS 16949:2009 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
V ISO 9001:2000 to ISO 9001:2008 - Identification in meeting notes. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
E Validity of ISO 9001:2000 Certificates - How to handle supplier ISO 9001 certificates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K Interpretation of the differences between ISO 9001: 2000 & 2008? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q How long is ISO 9001:2000 good for (valid) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N ISO 9001:2000 version to ISO 9001:2008 - Necessary Document Revisions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q ISO 9001:1994 Upgrading to ISO 9001:2000 or ISO 9001:2008? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D Time frame for validity of ISO 9001:2000 Certifications IATF 16949 - Automotive Quality Systems Standard 3
H Effectiveness of ISO 9001:2000 Implementation in small industrial organizations? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
J Is Version Change needed for ammending ISO 9001:2000 to 2008 Document Control Systems, Procedures, Forms and Templates 1
L ISO 9001:2000 vs. ISO 9001:2008 differences and concerns ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
R ISO 9001:2000 to ISO 9001:2008 Transition - Changing documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
C Recertification for ISO 9001:2000 - framework ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
D Relationship between ISO 9001:2000 and EFQM ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Acquisition (Merger) of an ISO certified to ISO 9001:2000 company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Is ISO 9001 Transition (from 2000 to 2008 version) Training Required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
pammesue Calibration - Clause 7.6 of ISO 9001:2000 - Is all this necessary? General Measurement Device and Calibration Topics 42
D To change or not to change? Our documents reference ISO 9001:2000 Document Control Systems, Procedures, Forms and Templates 31
A Registration to ISO 9001:2000 in 2009? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S What are the consequences of having an expired ISO 9001:2000 Certificate ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A A macro-process structure approach to auditing for ISO 9001:2000(8) General Auditing Discussions 19
B CNC Controls under ISO 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Marc Summary of ISO 9001:2000 and ISO 9001:2008 Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 166
A Brief discussion about ISO 9001:2000 clauses ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
K Advice on exclusion of 7.5.2 of the ISO 9001:2000 Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
L ISO 9001:2000 and CMMI v1.2 Integration and Org Deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
GStough REACH and ISO 9001:2000/13485:2003 - Never the Twain Shall Meet? RoHS, REACH, ELV, IMDS and Restricted Substances 4
S GAP Analysis for ISO 9001:2000 vs. ISO 13485:2003 ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 9001:2000 - Implementation in an Environmental Consulting Firm ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K Getting started with ISO 9001:2000 Templates Document Control Systems, Procedures, Forms and Templates 18
Z Synchronizing two quality management systems: ISO 9001:2000 Quality Manager and Management Related Issues 5
J ISO 9001:2000 4.2.3- Quality Records, Production Travelers Records and Data - Quality, Legal and Other Evidence 9
C ISO 9001:2000 Certificate - How to have a 3 year validity instead of 1? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
N When will ISO 9001:2000 Certificates turn into ISO 9001:2008? General Auditing Discussions 11
J Should product brochures be controlled per ISO 9001:2000? Document Control Systems, Procedures, Forms and Templates 2
I ISO 9001:2000 Recertification controls ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J ISO 9001:2000 7.3.5 "Verification" and 7.3.6 "Validation"- Clarification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
J Must you use an ISO 17025 lab in order to receive ISO 9001:2000 Certification ISO 17025 related Discussions 16

Similar threads

Top Bottom