Facility Preparation

[petdressiva]

Hi All,

Thank you for this site. I had been reading and it has been very helpful.

This is our status.
1. We are moving to new facility. (7km from original site)
2. We already informed our AO. Audit is imminent for our recertification audit. No audit plan yet but AO is drafting a new contract.
3. We are moving our equipments and medical devices to new facility.
4. Old site will remain open till we get our certification, but we intend to move everything in the new site .
5. We dont do manufacturing itself in our facility (all this process happens in overseas), we received it as semi finished goods in our facility, provide testing, labelling and release the product.

Question:
1. What are the documents that are needed to allow this move and to show that there is a control of the movement of our personnel, equipment and product to new site in terms of ISO 13485 MDSAP standpoint? What do you recommend? Is quality planning enough?

 

[Jen Kirley]

Hi All,

Thank you for this site. I had been reading and it has been very helpful.

This is our status.
1. We are moving to new facility. (7km from original site)
2. We already informed our AO. Audit is imminent for our recertification audit. No audit plan yet but AO is drafting a new contract.
3. We are moving our equipments and medical devices to new facility.
4. Old site will remain open till we get our certification, but we intend to move everything in the new site .
5. We dont do manufacturing itself in our facility (all this process happens in overseas), we received it as semi finished goods in our facility, provide testing, labelling and release the product.

Question:
1. What are the documents that are needed to allow this move and to show that there is a control of the movement of our personnel, equipment and product to new site in terms of ISO 13485 MDSAP standpoint? What do you recommend? Is quality planning enough?

Hello petdressiva,

If nothing is changing in the processes as a result of this move, we are left to question if the equipment is delivering the intended results after the move. This includes production equipment, but the primary focus is of course in inspection equipment such as CMM inspection units.

The Process Realization clause applies as part of the change management clause. Documentation that confirms the equipment continues to perform within expected parameters applies.

If the same employees will be performing the required tasks, no no documentation is required.

New employees who will be fulfilling responsibilities will be expected to have evidence of conformance of competency established.

I welcome my fellow Covers to add to this advice.

I hope this helps.

 

[ChrisM]

I've been involved in a similar move myself; we "validated" the new facility by several means, one of which was to test product in the old facility, note the results, move to new facility and re-test using same equipment. Test results within +/- 0.x% of previous means that everything is effectively the same after the move. of course there were many other steps including inspecting items before and after the move to check freedom from damage during the move etc

I recommend that you have some sort of "validation" plan to confirm that everything is the same after the move as before. If this can be agreed with your "AO" beforehand, so much the better.

 

[chris1price]

You should start with a change request, perform the impact assessments and risk analysis, these should tell you what you need to do.

 

[petdressiva]

Hi ChrisM, and Chris1price and Jen Kerley,

Thank you guys for your feedback. Appreciate your responses. All your inputs is something that I can use to start the quality plan for the move.

 

[Ed Panek]

Our auditor asked for a 'plan" to control how we did the move to demonstrate it was done in a state of control

 

[petdressiva]

Thank you Ed. Will you guys give me any format of how we can showcase we can control the move?

 

[Golfman25]

Our auditor asked for a 'plan" to control how we did the move to demonstrate it was done in a state of control

Obviously an auditor who's never moved a facility. Controlled chaos.

We essentially did what Chris M did. A before and after verification. And we actually left our auditors out of it as we where at recertification time and decided to just start new. Instead we worked directly with our customers on transition because it would effect their supply.

 

[petdressiva]

Golfman, we are currently on the same situation. Our recertification will be this August/September, although we informed them of the changes, we are having a hard time just to get a feedback from them. My perspective on this is to do the same thing as you guys recommended is to verified the devices and do same verification.

 

[Golfman25]

Golfman, we are currently on the same situation. Our recertification will be this August/September, although we informed them of the changes, we are having a hard time just to get a feedback from them. My perspective on this is to do the same thing as you guys recommended is to verified the devices and do same verification.

Honestly, I would keep your customer requirements and your auditors separate (one less thing to worry about). I know we like to integrate them -- meet customer requirements and all that. But my experience is the customer needs during a shut down and move are much more granular. We sat down with our big customers, and after the blood returned to their faces, went over our plans. We asked them for help in some areas, primarily holding some inventory and shipping schedules to alleviate the production gap. Came up with the before and after verification strategy -- heck they didn't want to do all the extra work either, so we cut right to the chase. At the end of the day, our move went without incident and had zero negative effect on our customers.

The ISO cert went bye bye for a few months, but guess what -- nobody even noticed.

Good luck.