SBS - The best value in QMS software

ISO 9001:2000 Clauses 7.4.3 & 8.2.4 - Incoming inspection records - need your input

C

ccochran

#1
Howdy, folks:

I am having a friendly dispute with one of my colleagues. I'd be interested in hearing your thoughts on the matter. The dispute relates to whether records are required when purchased product is verified. My buddy says no, based on this RAB interpretation of section 7.4.3, Verification of purchased Product:

"ISO 9001:2000 Clause(s) 7.4.3-- Does Clause 7.4.3 require records of the verification of purchased product? Interpretation: No."
[refer to Clause 7.4.3 - RFI-002]

I say this is flatly wrong, regardless of what RAB says. Here's my reason: Section 7.4.3 may not require records of verification, but section 8.2.4 (monitoring and measurement of product) certainly does:

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

Since verification of purchased product clearly falls into the category of “monitoring and measurement of product,” the requirements from that section of the standard apply. Records are obviously required.

If this issue has been discussed in a previous thread, accept my apologies. If not, please sound off!

Thanks for your input,
Craig
 
Last edited by a moderator:
Elsmar Forum Sponsor

RoxaneB

Super Moderator
Super Moderator
#3
:topic: I was almost set to be down in Atlanta from Aug. 29 - Sept. 1...but last minute arrangements have our meeting being conducted at our Tampa location now. And here I was, all set, to spend a night or two at Loca Luna with their horrible caipirihna's, but awesome live music.

Back on topic, personally, I believe records are required. But, as your colleague pointed out, 7.4.3 does not require inspection records, simply records of supplier evaluations and actions arising from the evaluations.

To me, good business sense implies two approaches with regards to suppliers.

First off, is the CYA-methodology. :) Paperwork is your objective evidence that you received (or didn't recieve) what your ordered (or didn't order). I mean, to not have this stuff seems to go against all good business sense, doesn't it?

Secondly, doing actually on-site audits of suppliers can be expensive for some organizations. I know that for us, we have suppliers from Brazil, Italy, China, etc...while I would love to audit them, my passport would quickly fill up and the expense account would quickly drain with such travels. Having this paperwork is a good way to evaluate your supplier on such items as paperwork, on-time-delivery, and getting what you ordered....perfectly aligned with 8.2.4, and the base for a supplier evaluation programme.

It is rather suprising that there is no specific requirement for records 7.4.3. I'd like to think that the TC176 was thinking that the records would be demonstrated via 7.4.1, but 8.2.4 does, as you pointed out, Craig, provide that more definitive link to the maintaining of records for products received from suppliers.

The Accreditation Bureau (be it RAB, RvA, or whomever) has the final say based upon the response from TC176. I, too, am having a difficult understanding how "No" would be appropriate. Clearly, there is no need for records in 7.4.3, but when I read 8.2.4's "Evidence of conformity with the acceptance criteria shall be maintained", I am unable to see how records of incoming product can not be maintained.

I've got some circular logic racing through my brain right now - and I'm working on just a few sips of coffee. I mean, there's no explicit requirement (7.4.3), but how can you not have it (8.2.4)?

I need to muddle a bit more on this offline....
 

Douglas E. Purdy

Quite Involved in Discussions
#4
Submit to ISO with Background

Can someone submit this issue for ISO Interpretation with the background presented with this post? It would be nice!

Thanks,
Doug
 

Howard Atkins

Forum Administrator
Staff member
Admin
#5
There are a number of different aspects of the question here.

Just because the standard does not say you must does not mean you don't, the old story about no work instruction about using the toilet.
There are a large number of things the standard does not say you must do but most organisations do any way.

I am afraid I must disagree with Craig and Roxane, according to my interpretation of product based on ISO9000:2000, the product in 8.2.4 is your product and not your suppliers, the release is that of you product.

If we go to ISO/TS 16949 then in
7.4.3.2 Supplier monitoring
Supplier performance shall be monitored through the following indicators:
- delivered product quality;
- customer disruptions including field returns;
- delivery schedule performance (including incidents of premium freight);
- special status customer
Here as I see it you must have records otherwise you cannot monitor "delivered product quality", here you must have at least Yes/No
 
C

ccochran

#6
Great discussion. Consider this—

ISO 9000:2000 defines product as the “result of a process.” With this definition, there is no doubt that purchased product is a PRODUCT.

Section 7.4.3 requires inspection or other activities to ensure purchased product meets requirements. If the organization inspects, tests, checks, analyzes, or otherwise verifies the purchased product, then it is clearly monitoring and/or measuring a product. This brings us back to the requirements of section 8.2.4, monitoring and measurement of product, which requires records.

This isn’t just an academic argument. It’s something that comes up all the time during audits and consulting work. Most organizations maintain records of purchased product verification because their accounts payable departments won’t pay any invoices unless they can match them to records of receipt and verification. It’s a common-sense control issue. In this case, the ISO 9001:2000 requirements and common-sense controls match one another. The spider-web construction of ISO 9001:2000 just doesn’t make it very clear.

Howard, the closest reference to this issue in TS 16949 is probably 7.4.3.1, Incoming product quality, not 7.4.3.2, Supplier monitoring. If you look at the 3rd bullet of 7.4.3.1 it mentions “records of acceptable delivered product quality.”

Here’s a real good argument starter: The RAB does not have the final say in any issue. The people who have the final say are the users of standards and the people who teach them. If something in the standard is not clear--and the RAB’s clarification makes it even less clear--then it’s up to us to make sense out of it. I usually teach five or six RAB accredited ISO 9001 Lead Auditor courses every year. You don’t have to guess what I’m telling people about this requirement. I’m telling them what makes sense from a business standpoint, and I’m backing it up by showing how the requirements of ISO 9001 link to one another in a logical manner (i.e., like a set of interrelated processes).

More thoughts?

Craig
 
S

srqaeng

#7
It seems cut and dry that you need to verify purchased products thus some type of record is required so why wouldn't you maintain it?
 
S

sal881vw

#8
Craig,
I agree and of the same opinion as Howard.Not that one does not trust his supplier but incoming inspection greatly contributes to lesser process interruptions and product requirements ARE verified. IMHO it all depends on the cost of incoming inspection as well as the implications of an adverse situation.
Records further help to prove a case when needed.
 
M

mshell

#9
The depth of our incoming inspection depends on the impact of the purchased product on the final product. Some items are inspected per the Open P.O. report and acceptance is indicated on the receiving report. Others require the completion of an incoming inspection report which has specific instructions for the item code being receivied. Some require the taking and recording of measurements while others require comparison of the incoming good(s) to an approved sample. Either way, we maintain records of inspection and do so in order to ensure that we are meeting the requirements of section 8.2.4, monitoring and measurement of product, which requires records.

Each inspection record indicates acceptance or rejection of the incoming product and the person responsible for the decision which ensures that we can meet the requirements of 4.2.4 - "Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product."

So IMHO records of incoming inspection must be completed and maintained in order to meet the requirements of ISO 9001:2000. Not to mention the fact that it just makes sense to verify the quality of incoming product to your requirements.
 
#10
Very good question Craig,

First of all I think we’re all agreed that it usually is a good idea (regardless of how the standard is interpreted) to keep records from verification of purchased product. And so we shall… If we decide that keeping records is necessary to ensure that the purchased product meets the requirements. I’m certain that most of us decide that it is.

I would suggest that the key clause here is in fact 7.1d. What records do we need to ensure that processes and resulting product meet requirements? Those are the records we must have. But: What if we decide that no inspection of purchased product is necessary?

/Claes
 
Last edited by a moderator:
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
P 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