Quality Plan for Relocation of our Production

E

elsjanssens

#1
Dear all,

As the new building is almost finished and the re-location of our production is the next step, we were advised by our ISO9001 EN9100 auditor to make up a Quality plan.
This way the chance of forgetting important steps will be limited.
Has anyone done this before?
Advise more than welcome.:thanx:

Kind regards,
Els Janssens
 
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harry

Super Moderator
#2
Re: Quality plan for relocation

A process FMEA is another way to go.

Identify all the steps in this moving exercise and for each, brainstorm what could go wrong with each step and come up with suggestions to overcome (prevent) it.

Also discuss with your customers. If they need uninterrupted supplies, you may need to consider phasing out the moving process.

It is also time to go back to your records for 'lessons learned' - they served as inputs for preventing any repeat of poor layouts, infrastructure or other problems.
 
E

elsjanssens

#3
Re: Quality plan for relocation

Unfortunately doing a FMEA for the complete production will take more time then I can spend.
But I agree this would be the best way to go!
 

Stijloor

Staff member
Super Moderator
#4
Re: Quality plan for relocation

Dear all,

As the new building is almost finished and the re-location of our production is the next step, we were advised by our ISO9001 EN9100 auditor to make up a Quality plan.
This way the chance of forgetting important steps will be limited.
Has anyone done this before?
Advise more than welcome.:thanx:

Kind regards,
Els Janssens
Goedemiddag Els,

Moving a production operation is a project that has to be completed correctly and on time. Every project is unique in some manner, but has also elements in common with other projects. Project management comes to mind and there are quite a bit of tools available. Your auditor mentioned a quality plan, but any description of activities and necessary controls will be fine. I would not get too hung up on "Quality Plan."

Others may chime in with additional suggestions.

Stijloor.
 

qusys

Trusted Information Resource
#5
Re: Quality plan for relocation

Goedemiddag Els,

Moving a production operation is a project that has to be completed correctly and on time. Every project is unique in some manner, but has also elements in common with other projects. Project management comes to mind and there are quite a bit of tools available. Your auditor mentioned a quality plan, but any description of activities and necessary controls will be fine. I would not get too hung up on "Quality Plan."

Others may chime in with additional suggestions.

Stijloor.
Agree.
Probably the quality plan was also referred to the validation of the new production environment after the move out from the previous one.
In this case 6.3 and 6.4 of ISO 9001 should have been considered and re-assessed in the light of the relocation.
We do not have additional details about the type of production, if the production environment has to meet particular standard requirement or not.
So, just in case Els wants to give more news, we could give other interpretation.
However, the classical approach of project management is useful, in fact the organization can monitor the "quality" of the move out day by day. I am confident that the organization has tought about this in whatever shape, probably a structured approach based upon known methodology could be helpful so far for this huge change.:bigwave:
 

Statistical Steven

Statistician
Staff member
Super Moderator
#6
Dear all,

As the new building is almost finished and the re-location of our production is the next step, we were advised by our ISO9001 EN9100 auditor to make up a Quality plan.
This way the chance of forgetting important steps will be limited.
Has anyone done this before?
Advise more than welcome.:thanx:

Kind regards,
Els Janssens
The approach I use is to identify the Critical to Quality (CTQ), Critical Process Parameters (CPP), process output requirements and any validated processes I use. For each category you need to determine how to "prove" equivalence between the performance pre-move to post move. Are there any processes that will need to be re-validated? Do you have any environmental parameters that need to be monitored? Basically you go through the process and find areas where a failure to execute during the move can have impact on quality.
 

jkuil

Quite Involved in Discussions
#7
I have been involved in the transfer of the production site of a medical device production site from the Netherlands to Mexico. The transfer was handled via the change management process. It actually required multiple change request with scheduled implementation activities and appropiate validation and verification plans. The robust change management system faciltated the track and tracing of all required activities to effective completion.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#8
I like to use a hybrid of elements of what the medical/pharma industries use in their validation of special processes and what automotive/aerospace would look for:

Installation: A checklist that all equipment is installed correctly, proper electrical hookups, water, hydraulics, etc. does it turn on correctly? heat up correctly? etc. this ensures that the equipment wasn't catastrophically damaged in teh move and was installed correctly.

First article: at least one part is measured completely for each dimension, property or function and compared to past performance or specificaitons to ensure that the process didn't get catastrophically out of whack.

Process capability / Process Qualification: I would produce 3 sequential lots that have all CTQs measured or tested and analyzed for equivelent performance to specifications and past performance. I typically do a simple run chart of each characteristic for several lots just prior to the move and teh 3 lots just subsequent to the move. no fancy stats needed (unless your Customer requires it) just look at the charts - is the after performance equivelent in average adn variation to the before performance?
 
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