SBS - The best value in QMS software

Warehousing two separate components to a finished device while meeting regulations

#1
Hello I am not sure where this falls but we have a rolling cart that an electrical control unit can be bolted to. The cart has no connections or electrical. The unit can be used without the cart but right now they are sold together but will be shipped in two boxes. We want to inventory the final device but don't want to have to label the cart as part of the final device so there are no warehouse mix-ups and when an order goes out they grab the serialized device and any finished cart on the shelf.

Any thoughts on how to do this easily and still meet regulations?

Thanks you
 
Elsmar Forum Sponsor

indubioush

Quite Involved in Discussions
#2
When you say "device" do you mean medical device? Are you buying a medical device and distributing it as is without modification except for the cart switch? Are you a distributor, medical device manufacturer, or component supplier? What regulations apply to you?
 
#3
We are a medical device manufacturer. This device will control a catheter that is also manufactured by us. We fall under the Med Device regulations.
 

indubioush

Quite Involved in Discussions
#4
Assuming any cart can be used with any control unit...
When you receive medical device components, you check that the items meet your specifications. There is nothing wrong with having two different part numbers and specification documents for each of these items. When you receive and inspect the items, each gets its own lot number and part number and the paperwork will show traceability to the single order number. Then when your final device is shipped, your history record documentation needs to reflect the cart lot number that was used.
 
#5
Yes and that's the hard part because then the lot history technically wouldn't be closed until the item was shipped. These will be sold individually and not in lots either.
 

indubioush

Quite Involved in Discussions
#6
There is nothing that would prevent you from having a final kitting or shipping record. You can perform product release activities on the control unit and have it sit in your finished goods location. Then you will have a kit record that shows which control unit got matched with which cart when shipping. Do both items sit in their shipper boxes waiting to be shipped out? The customer assembles the control unit on the cart, correct?

A lot number can represent one unit.
 
#7
I realize that and that you need shipping records but I am not sure about the companies you have worked at but I always worry when the shipping department has to do stuff as they are always as stringent as many other departments in the company.
 
Thread starter Similar threads Forum Replies Date
B AS9100 Multiple Distributor warehousing locations under same Company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
E Good Warehousing Practices - Examples? Manufacturing and Related Processes 3
L Audit Nonconformity for FMEA - Transit, Warehousing and Shipping ISO 13485:2016 - Medical Device Quality Management Systems 4
M Auto Parts Warehousing Facility ISO 14001 Significant Aspects ISO 14001:2015 Specific Discussions 23
Q Warehousing and Distribution Operations - Books and Information help Book, Video, Blog and Web Site Reviews and Recommendations 6
S Warehousing and Transportation of Bottled Water Food Safety - ISO 22000, HACCP (21 CFR 120) 5
I Advice on Outsourcing all Manufacturing, Warehousing and Distribution Processes ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 9001 Requirements for Warehousing Data (Records) - Medical Device Distributor Records and Data - Quality, Legal and Other Evidence 3
R Added Value Benefits for a Warehousing Company to be ISO13485 Registered ISO 13485:2016 - Medical Device Quality Management Systems 4
T Beverage Warehousing & Distribution Audit - Seeking Checklist or Key Questions Document Control Systems, Procedures, Forms and Templates 5
R Warehousing: Is 7.3 applicable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
W Warehousing Department - Determining Measureable Objectives Preventive Action and Continuous Improvement 6
W Objectives for Warehousing Department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
W Warehousing under ISO/QS9000 QS-9000 - American Automotive Manufacturers Standard 2
L Separate Corrective Action and Preventive Action Procedures ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
H ISO 13485 - Separate Microbiology Audits ISO 13485:2016 - Medical Device Quality Management Systems 8
M UDI Database and EUDAMED - Will there be two separate databases? EU Medical Device Regulations 4
I Can a document (form) approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
CPhelan Internal audit - Combine similar nonconformities in one or keep separate? Internal Auditing 6
S "X-MR charts do not separate piece-to-piece repeatability of the process" Statistical Analysis Tools, Techniques and SPC 2
R How far apart can you schedule separate areas or departments in your internal audit? Internal Auditing 4
S Do we need separate stand alone procedure for Suspect Unapproved Parts? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
J Facilities - Placing our assembly group into a separate building ISO 13485:2016 - Medical Device Quality Management Systems 8
W Product Audit - It must be a separate and distinct activity (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 4
C ISO 14001 vs Existing Quality System - How to keep them separate? ISO 14001:2015 Specific Discussions 3
T Should Testing be a separate operation in the Control Plan? FMEA and Control Plans 5
P Two separate 510k submissions for one device from the same company Other US Medical Device Regulations 10
B ISO 9001:2015 8.4 External Providers - If work is transferred to a separate facility ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Is a separate ISO/TS16949 certificate required for an extension site? IATF 16949 - Automotive Quality Systems Standard 4
T Two Separate Businesses - Only Part of Company Certified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Separate Classifications for Medical Device Accessories EU Medical Device Regulations 2
R One-Time parts separate from QMS? Quality Manager and Management Related Issues 9
D Is a separate spreadsheet required for the ASL (Approved Supplier List)? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
R Connection to a generic separate power supply IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S Regulations for Selling Convenience Kit vs. Selling Separate Parts Other US Medical Device Regulations 2
cscalise Separate Forms or Procedure Attachments - What's more common? Document Control Systems, Procedures, Forms and Templates 2
C Do separate sites need separate documents? Document Control Systems, Procedures, Forms and Templates 7
A Newly Incorporated Business - Separate Scope and/or Separate Cert? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
L Should Internal Audit CAPAs be kept separate from "normal" CAPAs? ISO 13485:2016 - Medical Device Quality Management Systems 6
P Separate procedures? ISO 14k System combined with OHSAS 18001 Occupational Health & Safety Management Standards 3
J Device Registration and Listing - Separate for Device and corresponding Instruments? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C How to handle Outsourcing with Same Site - Separate Cert ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B Two Separate Legal Entities - Manufacturer Vs. Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 20
Q Separate Quality System? Product line of a parent company spins off 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P How to separate Product Design Review, Verification, and Validation Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
C What can you do if Quality is treated as a separate function in an organization? Quality Manager and Management Related Issues 24
C Separate Certification - Can I combine documents for ISO14001, OHSAS18001 & AS4801? Miscellaneous Environmental Standards and EMS Related Discussions 3
S IEC 62366 - Embedded Software in separate Usability Engineering File? IEC 62366 - Medical Device Usability Engineering 1

Similar threads

Top Bottom