Production Equipment Forms - Case study with ISO 9001:2008

S

solarcon5

#1
Hello guys i need help please. Can someone answer in this problem ??
:(


?A small company that has been specialised in the production of plastic bags is been under investigation for compliance with ISO 9001:2008 ?.

During the inspection of Department of Production, it appeared that two ?Extruder? used the same (identical) production form but with different data encoding. In the ?Extruder? 1 production form brought encoding E-QA-7.5.1 -3, version 2 from 01/01/2012 and the Extruder 2 form production brought encoding E-QA-7.5.1 -3, version 1 since 01/06/2009?.

Is this confirmation or not according to ISO 9001:2008? And if it is, what paragraph is? HELP ME PLEASE !!!!
 
Elsmar Forum Sponsor
#2
Re: help for a case study with ISO 9001:2008

Perhaps you could give us your ideas? Are you studying for a test/exam? If you tell us what you think the answer is, that would help.
 
S

solarcon5

#3
Re: help for a case study with ISO 9001:2008

Thank for you answer Sir

Yes I am a student from Greece. Please did you any idea ?

I found Paragraph 7.5.3 mark 3 in ISO 9001:9008. Is it suitable ?
 
#4
Re: help for a case study with ISO 9001:2008

It appears to be an auditing question. Did you think there's a problem here? If so, why? Please describe why you think it's a problem.
 
S

solarcon5

#5
Re: help for a case study with ISO 9001:2008

i think has something to do with traceability traceability... I think is Non-Conformance with 7.5.3

7.5.3 IDENTIFY AND TRACK YOUR PRODUCTS

Establish the unique identity of your products.

Identify the monitoring and measurement status of your organization's products.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#6
Re: Case study with ISO 9001:2008

I assume you are referring to a form. I assume you mean each form is a bit different. Please define "data encoding".

Off hand it doesn't matter that although the production machines are identical each has a specialized form.

Do they make (extrude) the same exact product? Is one machine newer than the other? If they produce the same thing can the products one outputs be differentiated from products the other outputs? Is there a requirement for traceability to begin with?

The question does not really provide enough information to give a definitive answer. More information is needed.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
Re: Case study with ISO 9001:2008

Hello guys i need help please. Can someone answer in this problem ??
:(


?A small company that has been specialised in the production of plastic bags is been under investigation for compliance with ISO 9001:2008 ?.

During the inspection of Department of Production, it appeared that two ?Extruder? used the same (identical) production form but with different data encoding. In the ?Extruder? 1 production form brought encoding E-QA-7.5.1 -3, version 2 from 01/01/2012 and the Extruder 2 form production brought encoding E-QA-7.5.1 -3, version 1 since 01/06/2009?.

Is this confirmation or not according to ISO 9001:2008? And if it is, what paragraph is? HELP ME PLEASE !!!!
As Marc said, we would need more information to give a definitive answer, but, in principle, based on what I understood from the scenario you described, the different versions of the "production forms" might impact the homogeneity of the products; thus creating a quality problem. If that is the case, the problem, in terms of conformance with ISO 9001:2008 lies in section 4.2.3 d) & g). Apparently one of the forms is obsolete, and might be providing erroneous process setup parameters for the extruding machine.
 
S

solarcon5

#8
same (identical) production forms with different encoding numbers

I think that the use of extruder Involve the requirement for traceability
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#9
Probably is a traceability issue, with each "assigned" to a specific machine. Doesn't sound like a problem to me. Machines are never totally, truly identical.

For example - In metal forming you may have 2 identical presses but each will be a bit "different" in one way or another. Usually the production forms for each are identical but there is a place on the forum to identify which press the form was filled out at. The same condition is met by having a nearly identical form but (for example) a different form number for each (which sounds like what you are describing). This is not typically done because it's easier and cheaper to have a bunch of identical forms printed and have the operator identify which press (or machine) was used in a field on the form.
 
R

Randy Lefferts

#10
It sounds like a document control issue (4.2.3), as Sidney posted. Two identical forms being used with different rev. levels.

Solarcon - you have mentioned traceability a couple of times. Traceability (7.5.3) applies to the actual product. In 7.5.3 it does state that records shall be maintained. Your forms (that you apparently have 2 different versions of) become the records that include the appropriate information, once filled in. However, the forms will be controlled via the document control section of the standard. Thus, if I am reading your question correctly, your issue is with the 4.2.3 section of the standard, not the 7.5.3 section. You basically have 1 form (the original version one, dated 1/6/2009) that has been updated in 2012 (now becomes version two, dated 1/1/2012) and not all of the original 2009 forms have been removed from the production area (as required by 4.2.3) to prevent their use.

As I said, my response is based on the assumption that you are auditing your production area and found 2 identical forms with different revision levels, being used on 2 different machines. It is also assumed that what you mean by "data encoding" is actually the revision level.
 
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