Facilities - Placing our assembly group into a separate building

J

jtenrec

#1
We are are small medical device manufacturer and are ISO 13485:2016 certified. We are placing our assembly group into a separate building. Is ther anything that I need to do for ISO and for FDA?
 
Elsmar Forum Sponsor

Golfman25

Trusted Information Resource
#2
I don't specifically know about medical, but check with your registrar to ensure you don't need two certifications. In automotive, we where almost required to get two certs even though our "separate" buildings where only separated by a parking lot.
 

JoshuaFroud

Involved In Discussions
#3
I would look at the current scope of your registration. If you initially registered as a single site then you will need to notify your Registrar that you intend to change the scope of your registration. They are usually very much ok with this but will probably require an out of cycle audit of the new facility to bring it under your current certificate.

The Registrar I use has a "Change of QMS" form that covers a raft of different things that you submit, this covers things like change in senior management to site moves to additional sites. Submit the form, and they get back to you fairly rapidly with what is needed.

With the FDA you may need to look into registering the separate site as part of your business as part of the Device Registration and Listing process, again the best bet is to contact them directly and enquire.
 
J

jtenrec

#5
Thanks to all of you. I had mentioned it to our registrar during the last audit, but received no response. I will try again and will contact the regional FDA office. I realize that we will need to include it in the facility registration, but not sure if there is anything else that they require. I am in the process of revising a number of documents to accommodate the expansion.
 
#6
RE: FDA Registrations.

I lean towards separate registrations if at all possible, there is the perception (if not the actuality) of segregation of risk if there is a problem at one or another point in the process. Practically, I don't know what the FDA will go after - the company or the establishment, but there's a theoretical chance you can reduce the scope of any FDA action to an establishment if you can isolate the event to one process or the other.

If they are one establishment, then it is easy to update. If you haven't already done your annual registration, then I think it will be included in the annual fee. If you have done your annual registration, you should check whether you can make this change without incurring/accelerating fees.

So, you need to make a determination whether it will be the same establishment [a/k/a facility]. The definition of establishment is vague, at best. 21 CFR 807.3(c) defines establishment as "a place of business under one management [and or or] at one general physical location [and or or] at which a device is manufactured, assembled or otherwise processed." We view this as a conjunctive statement, meaning that all three of the conditions must be met in order for it to qualify as a single facility [a/k/a establishment].

So in our view of things, there would be no question that this building, if not at "one general physical location" or under separate management, would require a separate establishment registration because devices are assembled there.

Questions we ask to determine whether they are at the same "general physical location" are:

1. Does it have the street address/postal address? (i.e. does only the specific building identifier differ, not the street address)
2. Does it share utilities?
3. Is it on the same plot of land?
4. Are there any shared walls?
5. Are the buildings connected by a permanent or semi-permanent structure?
6. Do the facilities share common assets? (e.g. do you move the pre-assembled device components with a third-party or yourselves?)

For determining whether they are "under one management" we similarly ask some questions:

1. Is it the same legal entity?
2. Do the same people have decision-making authority at various levels (e.g. CEO is too high-level maybe, middle management seems to be the conservative test)?
3. Are there employees in common?
4. Does the work process flow seamlessly (in theory!) in between them?
5. Do they share accounting systems and consolidate their financial statements prepared for management? (not audited statements)

But this leaves a lot of interpretation and guesswork - our down and dirty test is whether they can legitimately obtain separate DUNS numbers. Bearing in mind our experience has been that Dun & Bradstreet will hand these things out like candy on Halloween because they can make more money.

Definition Source: CFR - Code of Federal Regulations Title 21
 
J

jtenrec

#7
RE: FDA Registrations.

I lean towards separate registrations if at all possible, there is the perception (if not the actuality) of segregation of risk if there is a problem at one or another point in the process. Practically, I don't know what the FDA will go after - the company or the establishment, but there's a theoretical chance you can reduce the scope of any FDA action to an establishment if you can isolate the event to one process or the other.

If they are one establishment, then it is easy to update. If you haven't already done your annual registration, then I think it will be included in the annual fee. If you have done your annual registration, you should check whether you can make this change without incurring/accelerating fees.

So, you need to make a determination whether it will be the same establishment [a/k/a facility]. The definition of establishment is vague, at best. 21 CFR 807.3(c) defines establishment as "a place of business under one management [and or or] at one general physical location [and or or] at which a device is manufactured, assembled or otherwise processed." We view this as a conjunctive statement, meaning that all three of the conditions must be met in order for it to qualify as a single facility [a/k/a establishment].

So in our view of things, there would be no question that this building, if not at "one general physical location" or under separate management, would require a separate establishment registration because devices are assembled there.

Questions we ask to determine whether they are at the same "general physical location" are:

1. Does it have the street address/postal address? (i.e. does only the specific building identifier differ, not the street address)
2. Does it share utilities?
3. Is it on the same plot of land?
4. Are there any shared walls?
5. Are the buildings connected by a permanent or semi-permanent structure?
6. Do the facilities share common assets? (e.g. do you move the pre-assembled device components with a third-party or yourselves?)

For determining whether they are "under one management" we similarly ask some questions:

1. Is it the same legal entity?
2. Do the same people have decision-making authority at various levels (e.g. CEO is too high-level maybe, middle management seems to be the conservative test)?
3. Are there employees in common?
4. Does the work process flow seamlessly (in theory!) in between them?
5. Do they share accounting systems and consolidate their financial statements prepared for management? (not audited statements)

But this leaves a lot of interpretation and guesswork - our down and dirty test is whether they can legitimately obtain separate DUNS numbers. Bearing in mind our experience has been that Dun & Bradstreet will hand these things out like candy on Halloween because they can make more money.

Definition Source: CFR - Code of Federal Regulations Title 21
You have raised a lot of good questions. These are the kind of things that we need raised.

1. The building is very close by-maybe 100' away, in a cluster of buildings, while ours is the only building on our lot. We own ours, but will be renting the new building. It has its own physical address, parking and entrance, but will be using our PO Box for mail and billing.
2. It has its own utilities.
3. It is on a separate adjacent lot within the industrial park.
4. There are no shared walls.
5. There is no physical connection between buildings
6. We will move pre-assembled parts to the new building to be assembled and shipped from there.

1. It is the same legal entity.
2. We are small. The owner/President is the overall decider with a Plant Manager for the manufacturing side and the Office Manager for the Assembly side.
3. Yes, there will be 4-6 employees in common.
4. The move will be in the next 6-9 weeks and yes, we do hope that the work process flow will be seamless.
5. Yes, the accounting, bills, financials, human resources will all be handled by the Office Manager.

From your questions, I feel like the water is muddy, not clear cut. What do you think?
 
#8
For me, this could easily be two facilities [a/k/a establishments], if management determined the additional costs, effort in maintenance and complexity in maintaining database registrations were justified. And again, I would suggest running the down and dirty DUNS number test.

Single Facility Test

Test 1: One Management - pretty clear you pass this test
Test 2: One General Physical Location - pass or fail - two addresses, separate plots of land, not connected - definitely two locations - but "general physical location" means what?

Looking to the FOOD REGS of the FDA, we get - what we lawyers would deem persuasive precedent: relevant, perhaps informative, but certainly non-binding information - some additional information:

"Facility means any establishment, structure, or structures under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, or holds food for consumption in the United States. Transport vehicles are not facilities if they hold food only in the usual course of business as carriers. A facility may consist of one or more contiguous structures, and a single building may house more than one distinct facility if the facilities are under separate ownership. The private residence of an individual is not a facility. Nonbottled water drinking water collection and distribution establishments and their structures are not facilities."

If I was being thorough, I would go back to see which regulation was passed first and whether the same people drafted them, which we might be able to divine why they are different - more particularly - why didn't the medical devices define a single facility as "one or more contiguous structures", opting for "one general physical location" - practical due to processing processes?

Anyway, really deep into the sticks here and it may be a tempest in a teapot. The consequences of choosing incorrectly (and the FDA may not be able to give you a definitive answer either, because we tried!) are minimal. This kind of non-compliance, if ever checked, is not serious unless there appears to be an intent to defraud the FDA or abuse the registration system. You're making a good faith investigation.

Ahh, the memories.
 
J

jtenrec

#9
As expected, for the FDA, I do add the 2nd building for the facilities registration (no big deal). Our registrar sent us: the "IAF Mandatory Document for the Audit and Certification of a Management System Operated by a Multi-Site Organization MD 1:2018): 4.4 It is the organization’s management system which must be audited and certified; furthermore, by definition, a management system audit is only based on a limited sample of the information available. However it must be demonstrated that the management system is capable of achieving its intended results for all sites involved."
I will be applying for a DUNS for the second site, so they will solve that issue or not.
I am in the process of revising the QMS documents to accommodate the changes and I expect that to be ongoing as we discover what works and what does not. Thanks to everyone who posted.
 
Thread starter Similar threads Forum Replies Date
I IVD - 98/79EC - class IIa - Annex to the EC from the NB states the CM as one of the facilities? CE Marking (Conformité Européene) / CB Scheme 2
C Security and access in cGMP facilities Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
S How to find technical specification for facilities maintainance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R IATF 16949 Clause 8.5.1.6 a) maintenance and repair facilities - Production tooling management and personnel IATF 16949 - Automotive Quality Systems Standard 4
M Informational The USFDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication Medical Device and FDA Regulations and Standards News 0
V Own foreign manufacturing facilities declared as sub-contractors ISO 13485:2016 - Medical Device Quality Management Systems 5
Y TQM Implementation in Facilities Department Misc. Quality Assurance and Business Systems Related Topics 2
C Performing an ISO 9001 based Supplier Audit - Multiple Supplier Facilities Supplier Quality Assurance and other Supplier Issues 4
A Can Design & Dev (7.3) Be An Exclusion For A Facilities-based Service Company? Service Industry Specific Topics 7
T Section 4.3.1 - Limiting an EMS scope to facilities only ISO 14001:2015 Specific Discussions 3
H Facilities Management Certification Service Industry Specific Topics 2
K Combining ISO9001:2008 in Two Facilities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
F Implementing ISO 11135 - Facilities Conditions - Adding ETO Sterilization Other Medical Device Related Standards 4
A NonConformance Reports for non ISO facilities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
C Policy for 3rd Party Auditing of Sequencing Facilities IATF 16949 - Automotive Quality Systems Standard 6
S ISO 14001 for Mental Healthcare Facilities ISO 14001:2015 Specific Discussions 3
A Work Transfer Between Facilities AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
V Can identical gages in different facilities be in the same family? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
R Quality System for Multiple Facilities 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
V Auditing Treatment, Storage and Disposal Facilities - Non-Visit Audit ISO 14001:2015 Specific Discussions 20
J List of FDA approved Manufacturing facilities (India) ?? US Food and Drug Administration (FDA) 6
Manix Do Gauges used for Maintenance of the Facilities Require Calibration IATF 16949 - Automotive Quality Systems Standard 5
gard2372 ISO 17025 Certified Calibration Laboratory Has Moved Facilities ISO 17025 related Discussions 6
C Is Renault expecting all suppliers test facilities to be ISO/IEC17025 ISO 17025 related Discussions 4
E Extension of Scope in terms of Laboratory Facilities General Measurement Device and Calibration Topics 2
Y Internal Audits of All Facilities World Wide Before the Certification Audit Internal Auditing 9
A Which Subcontractors or Facilities need to be listed on a Quality System Certificate? ISO 13485:2016 - Medical Device Quality Management Systems 11
J Free Warehouse Layout & Planning Guide and Facilities & Workplace Design guide Design and Development of Products and Processes 10
A Are ISO 9001 certified companies required to use ISO17025 facilities for calibration? ISO 17025 related Discussions 13
M Outsourcing Design Work to Sister Facilities - How to best go about doing this Design and Development of Products and Processes 3
ScottK Organization chart for two manufacturing facilities under one corportate umbrella Misc. Quality Assurance and Business Systems Related Topics 3
T Potential Benefits - ISO 14001 for Waste Water Treatment Facilities and Water Utility ISO 14001:2015 Specific Discussions 2
Marc GM Dying in the US - GM ups job cuts to 30,000 jobs as it shuts plants, facilities World News 124
A EN 9100 7.5.1.4 Control of work transferred outside the organization's facilities AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Any requirement that the Quality Policy copies posted in facilities must be signed? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
C Separation of Facilities - Part 145 Repair Station AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 37
K Guidance to Guide 66 as it relates to registration for multiple facilities Miscellaneous Environmental Standards and EMS Related Discussions 1
B Solid Waste Landfills and ISO 14001 - May become Permit condition for new facilities ISO 14001:2015 Specific Discussions 1
Q GM's GP-10 - Evaluation and Accreditation of Supplier Test Facilities Customer and Company Specific Requirements 14
Y 4.2.6 Facilities and Tooling Management QS-9000 - American Automotive Manufacturers Standard 0
L Facilities and Tooling Management QS-9000 - American Automotive Manufacturers Standard 3
B GM ACCREDITED TESTING FACILITIES QS-9000 - American Automotive Manufacturers Standard 1
D Total Productive Maintenance (TPM) - What is a facilities managers role? Preventive Action and Continuous Improvement 7
Marc ISO 9001 Clause 6.3 Facilities and 6.4 Work Environment - Discussion ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
M Facilities and Tooling Management QS-9000 - American Automotive Manufacturers Standard 2
N Facilities and Tooling Management QS-9000 - American Automotive Manufacturers Standard 1
L Facilities and Tooling Mgt. 4.2.6 QS-9000 - American Automotive Manufacturers Standard 10
S Placing a calibration sticker with someone other than your initials Records and Data - Quality, Legal and Other Evidence 8
M Sample record for verification performed by importers before placing a device on the market EU Medical Device Regulations 0
R SaMD - Placing on the Market before DoA EU Medical Device Regulations 2

Similar threads

Top Bottom