Drinks on the shop Floor? Stainless Steel Medical Devices

cbearden

Involved In Discussions
#1
We manufacture medical devices out of stainless steel. We are getting ready for our Registration Audit for ISO13485 and the FDA standard.
My question is this:
At your facility, are the employees allowed to have drinks or food on the shop floor?.....and when I say drinks, I mean a drink with a closed lid on it.

Thanks,
ZeissUser
 
Elsmar Forum Sponsor

GStough

Staff member
Super Moderator
#2
Re: Drinks on the shop Floor????

My past experience has been that there should be no food or drinks on the production floor. FDA and GMPs tend to frown on this as it poses the potential for contamination.
 
R

ralphsulser

#3
Re: Drinks on the shop Floor????

We manufacture steel gears, no food or drinks allowed any where in factory or offices. Only allowed in cafeteria, or outside on patio.
 

cbearden

Involved In Discussions
#4
Re: Drinks on the shop Floor????

Wow.....that makes for a not-so-pleasant working environment.....but I guess you get used to it over time.
Most of our parts go through a very extensive cleaning process like electropolish or passivate prior to shipping.

Zeissuser
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Re: Drinks on the shop Floor????

http://www.fda.gov/cdrh/qsr/06bldng.html#contamination_control


Personal Practices
If eating, drinking, or smoking could have an adverse affect on the devices' fitness for use, manufacturing procedures should include instructions on how to avoid such adverse effects [820.70(d)]. For example, these activities could be confined to specially designated areas such as a lunch room or employees lounge. Directions and containers or equipment should be provided for timely and safe disposal of trash, by­products, effluents and other refuse.
 

SteelMaiden

Super Moderator
Super Moderator
#6
Re: Drinks on the shop Floor????

The no eating or drinking rules, when present, are not always for protection of the product, they may be in place for the protection of the employee.
 

Wesley Richardson

Wes R
Trusted Information Resource
#7
Re: Drinks on the shop Floor????

The no eating or drinking rules, when present, are not always for protection of the product, they may be in place for the protection of the employee.
At a testing laboratory where I previously worked, we were cited by OSHA as a violation for allowing food and drinks in the work areas. They then followed up by requiring air monitoring be worn on several of the employees (at company expense) and sampling of the lunch room table for contaminants.

The two primary areas they were concerned about were the machine shop area, where there was various types of drilling, sawing, grinding, etc. of metal samples, and in the chemical analysis area, where there were metal samples and chemical reagents.

Results showed that the breathed air was about 1/100 of permissible levels, at maximum, and the lunch room table was about 1/10 of permissible level for one metal element. We changed the policy to no food or drink in work areas, and employees were supposed to wash their hands before eating or drinking. They were allowed to eat in the lunch room or outside on picnic tables. We still ended up paying some fines, as it was felt it was less expensive than getting a lawyer or fighting it, even though we were technically in compliance.

Wes R.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#8
Re: Drinks on the shop Floor????

I've worked in pharma, device, and food regulated packaging companies.
In all cases the only food item we allowed on the production floor was bottled water (in one company we provided refillable sports bottles) products.
And these had to be kept at the workbench for each workstation, never sat atop any part of a machine.
 

Crusader

Trusted Information Resource
#9
We manufacture medical devices out of stainless steel. We are getting ready for our Registration Audit for ISO13485 and the FDA standard.
My question is this:
At your facility, are the employees allowed to have drinks or food on the shop floor?.....and when I say drinks, I mean a drink with a closed lid on it.

Thanks,
ZeissUser
At our machining / assembly facilities, it is allowed from what I see. It is a must at our foundry because it is well over 100 degrees in the shop:mg: and in the summer time it is well over 100 degrees outside the shop! :mg: There is no air conditioning either. I believe the furnaces are 1200+ degrees....I tend to walk a little faster past those!:lol:
 

Al Rosen

Staff member
Super Moderator
#10
At our machining / assembly facilities, it is allowed from what I see. It is a must at our foundry because it is well over 100 degrees in the shop:mg: and in the summer time it is well over 100 degrees outside the shop! :mg: There is no air conditioning either. I believe the furnaces are 1200+ degrees....I tend to walk a little faster past those!:lol:
I'm sure the government inspector will understand and be sympathetic.:rolleyes:
 
Thread starter Similar threads Forum Replies Date
Q Who drinks water? Who owns the zebra? Coffee Break and Water Cooler Discussions 3
U America's Unhealthiest drinks Coffee Break and Water Cooler Discussions 23
T ISO 9001:2015 - Small Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
qualprod Automation in manufacturing - Print Shop ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
B Product Safety Responsibility - Job shop such as a machine shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
JAMESH Building a "Lean" Job Shop Training Program Training - Internal, External, Online and Distance Learning 0
F AS9100D Process Matrix for a small cnc machine shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T QMS Template Help - Small machine shop/job shop Manufacturing and Related Processes 1
J Starting from scratch - a plethora of challenges for a new Lumber Mill Machine Shop Quality Management System (QMS) Manuals 11
T EN 10204 3.1 Inspection Certificate - Machine Shop Various Other Specifications, Standards, and related Requirements 4
qualprod Criteria for print shop - How do you consider the cycle time in a print shop? Lean in Manufacturing and Service Industries 21
P Paint shop vs PPAP requirements IATF 16949 - Automotive Quality Systems Standard 5
apestate Inexpensive Gage Blocks for small aerospace startup shop General Measurement Device and Calibration Topics 1
M AS9100d (section 7.1.3) example of compliance in machine shop environment. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
E Small one man shop with QMS (shoptech e2) | AS9100 cert help AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 46
B ISO 9001:2015 for a Small Machine Shop need Resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H AS9100D Cert question - Small machine shop - Where can I buy a certificate? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Need Continuous improvement Suggestions - Small (30 of us) all-CNC machine shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
D Number of Audit Days - AS9100D Transition for a Small Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M AS9100D excluding Design and Development - Small Job Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
T AS9100 Shop Travelers - Six Questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
M Industry Standards - Sheet Metal a Machine Shop Manufacturing and Related Processes 1
J Suggestions on Inadequate Resources in a Small Machine Shop Nonconformance and Corrective Action 2
D Implementing 5S for Multiple Shop Floor Layout Workstations Lean in Manufacturing and Service Industries 2
A What KPI's do you use at Shop Floor Level and Team Boards? Quality Tools, Improvement and Analysis 4
M API Monogram License for a Small Machine Shop Oil and Gas Industry Standards and Regulations 1
D AS9100 Routing (Shop Traveler) requirements per 7.5.1 g and h AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J QMS and ISO 9001 for a Single Person Machine Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
S Job travelers through a machine shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Proper Gauging - GD&T - Attribute gage to check true positioning on the shop floor Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
A Start Up of a small AS9100 Machine Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Suggestions for a 100% Paperless Manufacturing Shop Floor Quality Tools, Improvement and Analysis 10
Ron Rompen MSA Studies of Instruments in a Paint Shop Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
S How will ISO 9001 help the machinists in a very small Machine Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
Q KPI's (key performance indicators) for a Print shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q In a Print Shop the Products are Special Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B Internal Audit requirements in a One Man Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
R Gage Identification Methods in a Job Shop Calibration Frequency (Interval) 8
P Work Area (Production Shop Floor) Training Matrix Requirements Training - Internal, External, Online and Distance Learning 4
B Machine Shop Yield and Cost - Productivity, Yield and Absorption Performance Manufacturing and Related Processes 3
M Start New Machine Shop OR BUY Business Continuity & Resiliency Planning (BCRP) 9
Q Help With Airflow Control in a mid sized Job Shop in Southwest Florida Manufacturing and Related Processes 2
B How did you grow your QMS in a Job Shop? Quality Manager and Management Related Issues 11
B Plating Shop - Forums specifically related to the plating / metal finishing industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Determing Machine Capability in a High Mix, Low Volume Sheet Metal Shop Manufacturing and Related Processes 4
B Shop Drawings that Integrate Information from a Database Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
S Current Inspection Standard for AS9100 Certified Job Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
H ISO Quality Procedures for a Small Shop Document Control Systems, Procedures, Forms and Templates 44
M Machine Shop Process Instructions (Traveler) question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
J Use of PPMs in Low Volume Machine Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5

Similar threads

Top Bottom