Warehouse Design Layout - FDA Regulated Medical Manufacturer

L

LGDeneault

#1
Greeting Fellow Eslmar Cove-ers!

We are in the midst of *COMPLETELY* re-doing our FDA Regulated, medical device warehouse and I would like to know if anyone out there has or knows of a really great way to layout a warehouse to incorporate Receiving/Holding/Accepted/Rejected Areas. Also, what is the best way to distinguish these areas and segregation (colored tape on floor, cages, etc.).

We are also using this time to do an accurate inventory audit, since this has NEVER been done quite accurately... Won't it be nice to be able to give the President an answer, "Yes Sir, we can easily build 1000 of the Model #1234!"...

I would really hate to get ALL of the way thru this process and discover a really great and cool way to organize this warehouse...

Thanks, in advance, for your time and consideration!

Best!

LEE

A bit...

:topic:
 
Elsmar Forum Sponsor

Scott Catron

True Artisan
Super Moderator
#2
LGDeneault said:
Greeting Fellow Eslmar Cove-ers!
We are in the midst of *COMPLETELY* re-doing our FDA Regulated, medical device warehouse and I would like to know if anyone out there has or knows of a really great way to layout a warehouse to incorporate Receiving/Holding/Accepted/Rejected Areas.
We have warehousing and production all in one building - the incoming hold area is just off the receiving dock on the west side of the building, approved components on the north side, production is on the east, product waiting approval is SW and approved product is SE.

Our space is small so there's not much else we can do - not sure it qualifies as a "great way" to do things, but it's simple and easy to explain to visitors/auditors.
LGDeneault said:
Also, what is the best way to distinguish these areas and segregation (colored tape on floor, cages, etc.).
We use signs on the pallet racks to lable the various areas. For areas where we don't have racks (and because volume can be variable), we use portable plastic chains attached to stands (with signs as appropriate) to divide areas as the situation warrents on the floor - mostly in the receiving/hold and the finished products hold/approved areas.

Hope that helps.
 
J

jmp4429

#3
I can't really give you much help with the layout. It depends on the shape and size of the space you have to work with. You might try doing a spaghetti diagram to see if material and people are travelling an inordinate amount.

LGDeneault said:
Also, what is the best way to distinguish these areas and segregation (colored tape on floor, cages, etc.).
I always like cages for stuff that people shouldn't be getting into - i.e. nonconforming or suspect material, or even parts awaiting incoming inspection. It prevents un-inspected or suspect parts from accidentally finding their way into the product. In my experience, without a locked cage, material with unknown status will *always* find its way into production.
Then again, if access is limited enough and your people are conscientious enough to prevent this, I don't see why color coded taped off areas wouldn't suffice. I'm only vaguely familiar with FDA regs, though.

If you are going to use floor tape to mark aisles, different product areas, or whatever in an area with heavy fork truck traffic, I recommend DuraStripe tape over vinyl tape. (No, I don't have any affiliation with them). It's a good bit more expensive than vinyl tape, but lasts so much longer that it ended up being a cost savings. In our shipping and receiving areas, we used to have to pull up and replace all our tape every two weeks. The new DuraStripe stuff has lasted 6 months so far. We've not only saved money on the cost of tape (the sheer volume of the vinyl stuff we went through was incredible) but also the labor to pull up and replace tape. A word of caution with the DuraStripe is that you have to get the floor good and clean before you lay it down.

Hope someone else can better help you with the layout!
 
Thread starter Similar threads Forum Replies Date
C Warehouse Layout Design Lean in Manufacturing and Service Industries 11
J Free Warehouse Layout & Planning Guide and Facilities & Workplace Design guide Design and Development of Products and Processes 10
J Warehouse Floorspace Utilization Manufacturing and Related Processes 3
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2
L Significant change notice for outsourced warehouse Medical Device and FDA Regulations and Standards News 2
M Pharmaceuticals Warehouse temperature control (room temperature) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
B Software for setting up New Warehouse Manufacturing and Related Processes 0
R Is there a mandatory medical device warehouse standard for europe? EU Medical Device Regulations 3
R Warehouse and shipping/receiving activities need to be part of our scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
G How to cover another manufacturing "site" or warehouse into current ISO 13485 cert ISO 13485:2016 - Medical Device Quality Management Systems 7
P Non Conforming Material in the Warehouse..to tag or not? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D AS9100 section for Warehouse/Preservation of materials? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R Brand New Warehouse - FMEA example wanted FMEA and Control Plans 9
B Fire Extinguisher Requirements for a Warehouse Vehicle Miscellaneous Environmental Standards and EMS Related Discussions 2
S Package Storage Direction in an I.T. Warehouse ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M FDA Wall Clearance Requirements For Warehouse 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
M Critical Limits for CCP in a food storage warehouse Food Safety - ISO 22000, HACCP (21 CFR 120) 4
A Food Warehouse ISO 9001 Audit and Newbie Introduction ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Calibration in Warehouse Environment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Movement of Final Product from One Warehouse to Another Manufacturing and Related Processes 2
R HACCP for Packaging, Labeling and Warehouse of Food Products Food Safety - ISO 22000, HACCP (21 CFR 120) 13
S Building and Warehouse requirements of OHSAS 18001 Occupational Health & Safety Management Standards 8
S Single Warehouse used by two different companies - One is ISO 13485 registered Quality Manager and Management Related Issues 1
T Outsourcing Shipping Product directly from our Warehouse to the End Customer ISO 13485:2016 - Medical Device Quality Management Systems 2
J HACCP and ISO22000 - Brewery and Warehouse Food Safety - ISO 22000, HACCP (21 CFR 120) 13
M Kanban vs. Line Balancing - Process Engineering our Warehouse Process Lean in Manufacturing and Service Industries 3
M Internal Warehouse Handling - A Reverse Logistic Case! Process Maps, Process Mapping and Turtle Diagrams 6
N 100% Inspection in Retail Warehouse which Ships Products to Customers Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
B TS 16949 Upgrade for Distribution Warehouse IATF 16949 - Automotive Quality Systems Standard 4
L Writing a Shipping and Receiving Procedure - Designated Warehouse Locations ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q Electronic Process Examples (IT Data Warehouse) Human Factors and Ergonomics in Engineering 1
N Managing Subcontracting Process - Material Traceability from Warehouse to Processing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q Control plans for Incoming, Warehouse and Shipping process FMEA and Control Plans 5
bgot62 Secondary Operations and an uncontrolled document in the warehouse ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
H Forklift Safety - Driver loses control in warehouse (Video) Occupational Health & Safety Management Standards 2
R VMP template for Temperature Data Loggers in a Pharma Warehouse Qualification and Validation (including 21 CFR Part 11) 4
P Warehouse Audit - Nonconformance or not - That is the question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
A Rental Warehouse Audit required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
G Manufacturing -> Warehouse -> Tier 1/OEM - Process flow, PFMEA, & Control Plan FMEA and Control Plans 9
D Should I put Warehouse under Manufacturing Department? Misc. Quality Assurance and Business Systems Related Topics 8
A Production Planning, Scheduling and Warehouse Management Manufacturing and Related Processes 8
I How to Balance a Warehouse System Lean in Manufacturing and Service Industries 2
I Time Analysis of Logistics in a Warehouse Lean in Manufacturing and Service Industries 3
C Requirements for Process Chemical Storage in a Warehouse Miscellaneous Environmental Standards and EMS Related Discussions 20
M Dock to Stock Template for Distributor/Warehouse of Industrial Metals Document Control Systems, Procedures, Forms and Templates 5
A Warehouse Internal Audit - Seeking Tips and Advice Internal Auditing 17
M President of company wants ISO 17025 for testing - Warehouse distributor ISO 17025 related Discussions 3
M Warehouse Space Utilization Spreadsheet Document Control Systems, Procedures, Forms and Templates 5
T Warehouse Fire: QMS Involvement? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
D Segregation of Product by Type and Production Week - Warehouse General Auditing Discussions 2

Similar threads

Top Bottom