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

G

Greg B

#21
Hi All,
Great thread Craig and excellent points expressed by all. I looked in a few books and came up with no solid answers. 9004 told me nothing so I looked in my old course material from my Registrar 'Understanding the ISO 9000:2000 standards'. My certification body is the largest in Australasia and it's parent is Standards Australia (the ultimate governing body)
In th notes, 7.4.3 spells out the actual standard and underneath that it says:
'You also need to determine the verification methods of any purchased product. This may vary depending on the type and impact of the product. If it is to be verified and released at the supplier's premises, this needs to be documented in the purchase information.'
So as you can see, this is as clear as mud. Personally, I agree with those that state this clause deals with incoming product only....but...you would be mad not to document the receipt of this product against a checklist of requirements (specification). This is exactly what we do because if later we tried to use it and it failed we would have a weaker case against the supplier. It also gives us peace of mind that the product going into our processes meets the same standards as those we take form our own mines.

8.2.4 again it goes thru the standard and then states 'On a day to day basis, the processes and products required to satisfy customer requirements must be monitored. Hopefully, through this monitoring, you identify potential supply problems before they become a problem. The product must be verified at each key step of the realisation, with records to demonstrate acceptance to be maintained, and should identify the person with authority to release acceptable product. If the product or service does not pass all checks, it can only proceed with customer's authority' Now this statement would tend to back up Craig's original post as it includes the initial supplied product as the start of the overall inputs and thus part of the realisation process. (This could get very confusing if we weren't rationale, level headed people :lmao: ).
My company monitors both areas thru documentation, records and specifications. As Roxane and others state Good Business Practises dictate that we must ensure conformity of our product and the only way to do this is to 'check it'. The standard needs to be clearer and 7.4.3 should be amended to reference 8.2.4.
 
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#22
M Greenaway said:
Claes

Where does ISO define which processes must be measured such that you can give your categorical 'no' answer to the question - must all processes be measured ?
Fair question... I was on my way home when I wrote that, and didn’t quite finish it (to put it mildly).… embarrassed.gif
ISO9001:2000 said:
4.1: The organization shall

a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),
e) monitor, measure and analyse these processes,


8.2.3:

The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes.
Imo, 4.1 seems to indicate that there could be other processes, and 8.2.3 requires measurement where applicable.

/Claes
 
S

sal881vw

#23
Objective evidence

Craig,
As already stated by myself and others records are needed. Further to your question I am of the opinion that RAB’s interpretation is very misleading and wrong.

Clause 7.4.3 is dictating (shall) that inspection of purchased product must be established and implemented to ensure that the product (purchased, my brackets) meets specified purchase requirements.

Furthermore
Clause 7.1 Planning of product realization
The organization shall plan and develop the processes needed for product realization…………..quality management systems (see 4.1)
Clause 7.1 d) states
Records needed to provide evidence that the realization processes (“purchasing” where the most essential is that the purchased product is what we want, my brackets) and resulting product meet requirements.

Therefore based on the above objective evidence records of incoming inspection findings are needed.

I hope that my new post helps in some way.
 

Peter Fraser

Trusted Information Resource
#24
Howard Atkins said:
I agree that this is the definition of product but if one studies the Scope of ISO 9001:2000 then in the note to this clause 1.1 it says
"NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer."
Even more confusingly, ISO9000:2000 defines a "Customer" as: "an organization (3.3.1) or person that receives a product (3.4.2) ... NOTE A customer can be internal or external to the organization".

ISO9001:2000 then uses the term only in relation to the "external" definition.

How can we rely on these two documents to help us make sense of this when they contradict each other?
 
S

sal881vw

#25
Peter Fraser said:
Even more confusingly, ISO9000:2000 defines a "Customer" as: "an organization (3.3.1) or person that receives a product (3.4.2) ... NOTE A customer can be internal or external to the organization".

ISO9001:2000 then uses the term only in relation to the "external" definition.

How can we rely on these two documents to help us make sense of this when they contradict each other?
I beg to differ for the simple reason that if you look at Figure1-Model of a process based quality managment system ( sorry but I cannot display the figure).
It puts the pruduct realizer smack in the middle between the customers requirement (input) and the customer satisfaction (output).

In a very plain manner it says that customers are in fornt and behind us.

I can't help this,
It could be that the next edit standard may include customers to the sides :bonk:
 

Peter Fraser

Trusted Information Resource
#26
sal881vw said:
I beg to differ for the simple reason that if you look at Figure1-Model of a process based quality managment system ( sorry but I cannot display the figure).
It puts the pruduct realizer smack in the middle between the customers requirement (input) and the customer satisfaction (output).

In a very plain manner it says that customers are in fornt and behind us.

I can't help this,
It could be that the next edit standard may include customers to the sides :bonk:
We are agreeing without realising it - the so-called model of a management system shows customers as being external to the organisation. Not a problem to me, and it's the way many people think of a "customer", but it all gets confused and confusing when you then get the concept of "internal" customers receiving "products" from "processes" such as "staff training and development" (eg).

Far better to think of an organisation providing goods and services to its customers (normally in return for payment). How it organises itself, and manages the creation and delivery of these goods and services, is where "quality" needs to be applied, and the idea of "internal customers" is important.

Sorry if I have gone "off topic" a bit, but I feel that there are some really basic definitions and concepts in the standard that make life difficult. Plain English is needed - or perhaps Plain American?
 
R

RosieA

#27
I'm coming into this discussion a few months after it was posted, but I'm wondering, if there are no records kept, how would one audit receiving inspection? If there is no objective evidence, how can the auditor verify that the process has been effectively implemented?

The 2000 rev relies on records more heavily than previous revs. 4.2.4 states that "Records shall be established and maintained to provide evidence of conformity..."

It seems to me that 4.2.4 and 8.2.2 are the real controlling clauses on this issue.
 

Al Rosen

Staff member
Super Moderator
#28
:2cents:

ANSI/ISO/ASQ Q9000-2000:

3.1.2
requirement

need or expectation that is stated, generally implied or obligatory

3.8.1
objective evidence
data supporting the existance or verity of something

3.8.4
Verification

Confirmation through the provision of objective evidence(3.8.1) that specified requirements(3.1.2) have been fulfilled

Other than records what would be objective evidence ?
 
J

jaimezepeda

#29
Al Rosen said:
Other than records what would be objective evidence ?
An auditor's observation can be objective evidence. I mean if the registrar cannot trust its own auditor's judgement then why send them out to carry out audits.

Jaime
 

Al Rosen

Staff member
Super Moderator
#30
jaimezepeda said:
An auditor's observation can be objective evidence. I mean if the registrar cannot trust its own auditor's judgement then why send them out to carry out audits.

Jaime
In the context of this thread concerning receiving inspection. Besides, the auditor would make a record of the observation, if nothing more than a mark on a checklist.
 
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