Compliance with Part ID section of 7.5.3.

A

Acchi Larka

Friends,
Our registrar has informed me that if the Company has not brought resolution to the facilities wide part number identification problem by next surveillance audit that a major finding will be written. Summary of problem:

The Company operates using the old incentive pay system. Relevance?
Industrial Engineering lays out assembly lines based on labor efficiency and establishing incentive rates - parts placed in planned proximity to a specific workstation. Then they back away.

Restocking the assembly line: Material Handlers are responsible to restock to the locations established by Industrial Engineering.

Operators are responsible when consuming the parts to respect their location on the shelves and place things back where they got them.

Department Supervisors are responsible to ensure the integrity of their department is maintained by enforcing operator compliance to the line set up design.

Reality: Supervisors are not involved with this issue. Operators working under piecework rate move parts around to make assembly more expedient and few put things back where they got them. Operators change aspects of the layout Industrial Engineering established to make assembly more expedient.

Material Handlers try to place restocked items where they were established, but the locations move around and or accessibility to the restock site is often limited during production due to the size and quantities of the products being assembled, Or the part location on the shelving has been crossed out with black marker so something else can fill the space by some unknown "helper".

Internal auditors write findings every audit on this issue. Registrar's auditors acknowledge that internal auditors do this and have had enough.
I am expected to fix this. I have no resources and no management authority. When I bring attention to top management with photographic evidence to support my position, I'm told not to do this because it makes others in the management meeting feel bad....e.g., the Operations Manager.

I know for certain that the Major finding will be written if nothing changes, and I know that as a result I'll likely be shown the door. Process control for this issue is actually chaos. I don't know how to approach this problem. Any suggestions?
 

try2makeit

Quite Involved in Discussions
One of my questions is, do your assembly operators have any Instructions of what Parts need to be assembled to make a whole? And how are those parts identified in those work instructions?
 

Jim Wynne

Leader
Admin
Friends,
Our registrar has informed me that if the Company has not brought resolution to the facilities wide part number identification problem by next surveillance audit that a major finding will be written. Summary of problem:

The Company operates using the old incentive pay system. Relevance?
Industrial Engineering lays out assembly lines based on labor efficiency and establishing incentive rates - parts placed in planned proximity to a specific workstation. Then they back away.

Restocking the assembly line: Material Handlers are responsible to restock to the locations established by Industrial Engineering.

Operators are responsible when consuming the parts to respect their location on the shelves and place things back where they got them.

Department Supervisors are responsible to ensure the integrity of their department is maintained by enforcing operator compliance to the line set up design.

Reality: Supervisors are not involved with this issue. Operators working under piecework rate move parts around to make assembly more expedient and few put things back where they got them. Operators change aspects of the layout Industrial Engineering established to make assembly more expedient.

Material Handlers try to place restocked items where they were established, but the locations move around and or accessibility to the restock site is often limited during production due to the size and quantities of the products being assembled, Or the part location on the shelving has been crossed out with black marker so something else can fill the space by some unknown "helper".

Internal auditors write findings every audit on this issue. Registrar's auditors acknowledge that internal auditors do this and have had enough.
I am expected to fix this. I have no resources and no management authority. When I bring attention to top management with photographic evidence to support my position, I'm told not to do this because it makes others in the management meeting feel bad....e.g., the Operations Manager.

I know for certain that the Major finding will be written if nothing changes, and I know that as a result I'll likely be shown the door. Process control for this issue is actually chaos. I don't know how to approach this problem. Any suggestions?

I'm not sure what "part number identification" means in this context, or precisely what the problem is. If the auditor has identified a nonconformity, it would be good if you could give us the exact text of the NC statement.
Here are what appear to be the relevant bits of 7.5.3 (ISO 9001:2008):

Where appropriate, the organization shall identify the product by suitable means throughout product realization.
The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization.

The "where appropriate" in the first requirement might be relevant. As to the second requirement, are there issues with "product status"?
 
A

Acchi Larka

Try2makeit,
Thanks for your reply. To your question...yes there are work instructions that begin with a bill of material for the assembly station processes, then they show photos of the parts used when describing the assembly activity. That part is covered. The issue then becomes getting the right parts from the department shelves. Of course visual differentaition works even when part numbers on the shelves do not match what is supposed to be there per the IE layout plan. But there are cases too where visual differences are slight. Thanks again. Acchi
 
A

Acchi Larka

Hi Jim,

Thank you for your reply.

The issues: Some Parts are not marked; some parts have conflicting part numbers; some are not in designated locations.

Here's the Finding statement:
Finding: The organization does not always ensure product is properly identified.

Requirement: Where appropriate, the organization shall identify the product by suitable means throughout product realization.


Objective Evidence: (For multi-sites, list the site/building where the evidence was found: East Moline and Rock Island)
Observed product in several areas of both plants that had no material identification on it.

This was issued in September. Then the February surveillance he verbalized, "I see through internal audit records that you've documented the same problem multiple times and therefore I won't write it up today but, you have not corrected the problem from my last visit and that I should write a major at this time....but if its not corrected by July I will have no option but to write a major."

Hope this clarifies things.

Acchi Larka
 

Randy

Super Moderator
So when you receive the upcoming major your management is going to understand its a self inflicted wound and that the 2nd one could be lack of commitment?

What do you think their response will be when/if a recommendation is made to suspend or even revoke the certificate?
 

try2makeit

Quite Involved in Discussions
What do your Instruction say in regards of Material identification during the Part realization process?

Now if they say, Material removed from the warehouse needs to be identified with a Material tag that includes, but is not limited too: Material desc., serial number..etc.etc, then I would say you need to train everyone on this again and again.

I also would look at input from your assembly operators, maybe someone has a better idea on your Identification problem. Seeing that you stated, that they will re-arrange the area/cell their way to be more productive or easier on them instead of the way the IE has laid out. Not everything is written in stone. If it clearly is a better way of being efficient and better - change it.
 

Golfman25

Trusted Information Resource
Is this effecting you assembly quality -- ie; wrong parts used durring assembly? Or just creating inefficiency?

If it is me, I would get rid of "set locations" for parts because things change too much and the locations become irrelevant. I would focus on making sure there is part identification on each container -- label, tag, etc. Good luck.
 
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