Setting up a laboratory for a manfacturer shut down by FDA

T

TGroulx

#1
So I was recently picked up as a consultant to design a calibration lab and program for a med dev manf. that was previously shut down by the FDA.

We are essentially working from scratch, and still convincing manf. management that it is cheaper to do things properly as opposed to whipping them together.

Any advice on dealing with management? Any advice from people who have set up labs for med dev.? Any key notes from 17025 I should be aware of?

What about a full copy of 13485?

Thanks!


T
 
Elsmar Forum Sponsor

BradM

Staff member
Admin
#2
Re: Setting up a lab for a manf. that was shut down by FDA.

hello, T.!

Yes, I would obtain full copies of the specifications.

If you have not reviewed them yet, there are multiple postings on setting up calibration labs. There is a lot to it.

Are you sure it is cheaper to set up a calibration lab as opposed to having the instruments calibrated by a competent lab?

How many standards have you obtained, and how well-trained are the technicians?

If you get a chance, please provide a little more information about your specific setup.
 

CarolX

Super Moderator
Super Moderator
#3
Re: Setting up a lab for a manf. that was shut down by FDA.

What about a full copy of 13485?
Hi T - sounds like you have a challenge in front of you.

If you are asking for someone to provide you with a copy of 13485, please be aware that this document is copywritten and cannot be posted on this site.
 
T

TGroulx

#4
Re: Setting up a lab for a manf. that was shut down by FDA.

hello, T.!

Yes, I would obtain full copies of the specifications.
yea all they have here is the cliff's notes, the company does not even own a full version. :frust:

If you have not reviewed them yet, there are multiple postings on setting up calibration labs. There is a lot to it.
Where is this at?

Are you sure it is cheaper to set up a calibration lab as opposed to having the instruments calibrated by a competent lab?
I am sure it is more expensive, and have expressed that. However... Not my call. So I get paid to consult :agree:

How many standards have you obtained, and how well-trained are the technicians?
Standards are crap (my most exciting standard is is a Fluke 5500 and an out dated spec an), my one technician has been trying to convince me to continue to let him use MET/CAL (rev 1) and a couple of other programs, most of which are DOS based. and not set up for company of this size.

If you get a chance, please provide a little more information about your specific setup.
No procedures, a pile of equipment that looks like the left overs of a DRMO auction, and a technician Good thing I like a challenge!

Hi T - sounds like you have a challenge in front of you.

If you are asking for someone to provide you with a copy of 13485, please be aware that this document is copywritten and cannot be posted on this site.
Good info, so there is no free versions?

Thanks
 
Last edited by a moderator:

BradM

Staff member
Admin
#5
Re: Setting up a lab for a manf. that was shut down by FDA.

Where is this at?
For starters, look at the threads at the bottom of this post. So, pull this post up, go to the bottom, and surf those. There is a lot of information.

Then, put in "calibration lab" in the search function and search those. I (and many others) will be thrilled to help on this. I figured you can find a lot of already-posted information to speed up the learning curve.

How many instruments do you have for calibration?
 
T

TGroulx

#6
Re: Setting up a lab for a manf. that was shut down by FDA.

For starters, look at the threads at the bottom of this post. So, pull this post up, go to the bottom, and surf those. There is a lot of information.

Then, put in "calibration lab" in the search function and search those. I (and many others) will be thrilled to help on this. I figured you can find a lot of already-posted information to speed up the learning curve.

How many instruments do you have for calibration?
Looks like tops will be 2000

With about 1000 in house. Mostly Oscopes, Torque, DMM, Scopemeter, Dosimeter and light meters

My current plan is to get a Fluke 5525, 8508 and 9100 than pair up with a CDI standard, and send the rest out while the program evolves into a larger entity.

Just an Idea though.

I have a 30 day deadline to have a program designed and be in the implementation phase. :cool:
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#7
Re: Setting up a lab for a manf. that was shut down by FDA.

Looks like tops will be 2000

With about 1000 in house. Mostly Oscopes, Torque, DMM, Scopemeter, Dosimeter and light meters

My current plan is to get a Fluke 5525, 8508 and 9100 than pair up with a CDI standard, and send the rest out while the program evolves into a larger entity.

Just an Idea though.

I have a 30 day deadline to have a program designed and be in the implementation phase. :cool:
That will probably require obtaining a set of specs. If management wants a cal lab, management is going to need to invest in a copy of the requirements. :rolleyes: My guess is it would be one of the smallest expenses.
 
T

TGroulx

#8
Re: Setting up a lab for a manf. that was shut down by FDA.

That will probably require obtaining a set of specs. If management wants a cal lab, management is going to need to invest in a copy of the requirements. :rolleyes: My guess is it would be one of the smallest expenses.
Working on that as we speak.... :nopity:
 

BradM

Staff member
Admin
#9
1. Get the 17025 and use it as a guideline for practice.
2. Get a quotation for somebody to build/develop your cleanroom.
3. Price out new standards. If the olds ones pass calibration, you can use them as backup.
4. Price out purchasing/ writing procedures for performing calibrations.
5. Perform the uncertainty analyses for your systems.
6. Don't forget annual training/maintenance/recalibration costs.


Ok, that is your lab portion.

1. Enter every instrument into a database.
2. Assure that each instrument has a unique indentification tag.
3. Price out a database package, with the appropriate user license. It might be a good idea to assure ER/ES compliance, since this is FDA.
4. Don't forget annual software/ programming/database time into the costs.

Once you develop a proposal, and assure the funding, you can get into the details.
 
T

TGroulx

#10
1. Get the 17025 and use it as a guideline for practice.
2. Get a quotation for somebody to build/develop your cleanroom.
3. Price out new standards. If the olds ones pass calibration, you can use them as backup.
4. Price out purchasing/ writing procedures for performing calibrations.
5. Perform the uncertainty analyses for your systems.
6. Don't forget annual training/maintenance/recalibration costs.


Ok, that is your lab portion.

1. Enter every instrument into a database.
2. Assure that each instrument has a unique indentification tag.
3. Price out a database package, with the appropriate user license. It might be a good idea to assure ER/ES compliance, since this is FDA.
4. Don't forget annual software/ programming/database time into the costs.

Once you develop a proposal, and assure the funding, you can get into the details.
Thanks

Delivering Standards Quote Today
Uncert done
Writing a Training Program
Database Built - Currently doing a hands on comparison of equip to DB and correcting.
Everything IDed mostly
Currently using Gagepack, I dont like it reccomending a switch.

Budget is unlimited for the next 4 weeks.

ER/ES compliance. I can not find anything on this... Searched Elsmar and Google
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
B Quality Goals and Improvements in a Bioanalytical Laboratory Setting Quality Tools, Improvement and Analysis 1
R In-House Calibration Facility Requirements - Setting up a new in-house laboratory General Measurement Device and Calibration Topics 4
Ajit Basrur Setting up a new laboratory for testing our samples according to RoHS RoHS, REACH, ELV, IMDS and Restricted Substances 1
L Senior Project Help - Setting up a calibration laboratory General Measurement Device and Calibration Topics 5
J Advice on setting up an automotive test laboratory General Measurement Device and Calibration Topics 5
J Setting accuracy limit for a read out General Measurement Device and Calibration Topics 4
B Setting flexible packaging specification limits ISO 14971 - Medical Device Risk Management 4
I Setting action completion dates Nonconformance and Corrective Action 3
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 2
S Heat Sealers Upper and lower limit setting during OQ for Heat Sealer Qualification and Validation (including 21 CFR Part 11) 0
Ed Panek GDPR in Urgent Healthcare Setting Other ISO and International Standards and European Regulations 1
M Setting deadlines (ex. 45 days) for Document Registration & Review Cycle Document Control Systems, Procedures, Forms and Templates 3
Ashok sunder What are the criteria for setting a target KPI value against a quality objective? Benchmarking 7
K Setting Quality Objectives (for the first time) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
R ISO 11137 Gamma sterilization validation, dose setting, dose audit Other Medical Device Related Standards 1
M Best Practice for setting tolerances on a Drawing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
T Setting up a quality department in an Engineering Firm Quality Management System (QMS) Manuals 11
B Software for setting up New Warehouse Manufacturing and Related Processes 0
S Setting up the process - First piece inspections Statistical Analysis Tools, Techniques and SPC 3
A Add-On software for VMC to calculate setting time, Idle Time, OEE etc.. Manufacturing and Related Processes 2
G Setting Up a Basic Quality Lab for a small manufacturing company General Measurement Device and Calibration Topics 2
A Setting up an LLC as a Consultant Paid Consulting, Training and Services 27
A Setting initial Expiry Date of an IVD per BS EN 23640:2015 Other Medical Device Related Standards 12
Q Setting Quality Objectives with a Timeframe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Proud Liberal Setting up Prolink's QC-Gage to a Keyence IM-6225 Vision System Statistical Analysis Tools, Techniques and SPC 2
P Setting Acceptance Quality Limits (AQL) for New Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
Hami812 Cpk Setting Tolerance - Cart before the Horse? (Wifi Routers) Capability, Accuracy and Stability - Processes, Machines, etc. 3
K Bioburden 0 cfu for Dose Setting using the VDmax25 Other Medical Device Related Standards 9
A New company, no employees, Setting up a QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
F Setting up a new sterilization unit in a new facility 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
C ISO 14001 Recertification without setting Targets ISO 14001:2015 Specific Discussions 3
T Guidance - Setting up an integrated quality & environmental management system Career and Occupation Discussions 12
M Setting up a M1003 QA Program for the AAR Various Other Specifications, Standards, and related Requirements 2
A Setting up a Medical Device Distributor in Malaysia Other Medical Device Regulations World-Wide 16
R Irradiation Sterilization Dose Setting and Dose Audit Flow Charts ISO 13485:2016 - Medical Device Quality Management Systems 0
J Setting Up New QMS - New US Location ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Setting air gauging outside of a part tolerance Capability, Accuracy and Stability - Processes, Machines, etc. 2
S Target Setting - Internal metric(s) to drive Internal Processes Six Sigma 1
S MSA Help or guidelines - Plastics - Setting up an MSA on a multi cavity fixture Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
G Setting up a corporate umbrella QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Setting Quality Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
W Setting up from scratch - Looking for help (ISO9001 / ISO13485) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
F Setting up a New QMS for Certification when ISO 9001 is about to Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
P New to AS9100 Rev. C - Setting KPIs and FAI Reports AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
B Setting Lower Control Limit on Attributes Charts Statistical Analysis Tools, Techniques and SPC 9
J Lean 5S - Setting Min/Max Inventory Levels Lean in Manufacturing and Service Industries 3
V Setting Specification Limits for UOD (Uniformity) for Live Bacteria or Spores Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
D How do I make the Corporate QMS work in the manufacturing setting? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Setting Quality Objectives for Service, Repair and Sales ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q Setting Specification Limits Quality Tools, Improvement and Analysis 11

Similar threads

Top Bottom