Food and Drink in Production Areas - Manufacturer of FDA analytical and diagnostic

H

Harold

#1
I am the QA Manager for a manufacturer of analytical and diagnostic instruments. We are an FDA registered facility subject to the Quality System Regulation.

I am of the opinion that there should be no food or drink allowed in the electronic production and repair work area.

We wave solder circuit boards, perform touch-up on the boards, assemble components to boards, solder cable assemblies, assemble instruments etc. The Manufacturing Supervisors and Manager do not agree with my opinion. The feeling is that as long as your not eating directly over the work you are doing, it is not a problem.

I am wondering if anyone out there has had to deal with a situation similar to mine. I would appreciate any feed back.
 
Elsmar Forum Sponsor
H

HFowler

#2
Harold,

As an electronics manufacturer, you should be complying with the requirements of ANSI/ESD S20.20 Standard for Electrostatic Discharge Control. Clause 6.2.3.1 Protected Areas Requirement states that:

"All nonessential insulators, such as those made of plastics and paper (e.g. coffee cups, food wrappers and personal items) must be removed from workstations.

This may provide you with some "ammunition" to backup your opinion that there should be no food or drink allowed in the production or repair area.

Good Luck,
Hank Fowler
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
HFowler said:

ANSI/ESD S20.20 Standard for Electrostatic Discharge Control. Clause 6.2.3.1 Protected Areas Requirement states that:

"All nonessential insulators, such as those made of plastics and paper (e.g. coffee cups, food wrappers and personal items) must be removed from workstations.
Thanks for the spec and the section, Hank! I'm not familiar with that document and appreciate it.

My experience has been that in production areas, whether electronic or not, food and drink should be a big no-no. Many companies have allowed the practice for so long employees see it as close to a 'right' so it's a difficult practice to curb.
 
A

Alf Gulford

#4
Harold-

I can't give you a better answer than Hank and Marc but about three years ago we had an FDA-oriented consultant do an audit of our Class I manufacturing facility. When he found a couple of juice bottles and a partially eaten candy bar on work benchs he pointed out that, should an FDA investigator walk in and find them, we would immediately be pegged as a sub-standard, dirty facility (we're absolutely not!) and the investigator would start digging much deeper.

Anyone making Class II or III devices would have it even tougher.

Appearence and first impressions are extremely important.

Alf
 
T

tomvehoski

#5
I worked with a FDA label manufacturer (drug bottle labels and package inserts). They did not allow any food at the workstations, and only company issued water bottles. I believe this was an FDA rule. Sorry I can't provide a reference to the exact reference document.

I know that Michigan OSHA requirements prohibit food and drink at work stations where toxic materials are used. I would think solder, flux, cleaners, etc. could be considered toxic. Here is a link to the actual MIOSHA requirement - see section 7: *** DEAD LINK REMOVED ***

You may want to check your own local OSHA requirements, which I would guess would be similar.

Tom
 
Thread starter Similar threads Forum Replies Date
John Broomfield Interesting Discussion Regionally unique food and drink Coffee Break and Water Cooler Discussions 4
M Component Manufacturer of Food Stuffs Mfg. Equipment Parts - Eat Drink Policy ISO 13485:2016 - Medical Device Quality Management Systems 1
A Baby food manufacture - food safety requirements Food Safety - ISO 22000, HACCP (21 CFR 120) 0
Anonymous16-2 Labeling Question (Dietary Supplements/Food) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
J Minimum Supplier Certifications for Food Supplements Food Safety - ISO 22000, HACCP (21 CFR 120) 2
J How to Set Microbial Limits in Food Supplements Food Safety - ISO 22000, HACCP (21 CFR 120) 3
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
D Interesting Discussion Requirements for selling a Food product in USA Food Safety - ISO 22000, HACCP (21 CFR 120) 0
A Managing overseas travel risks to food handlers Food Safety - ISO 22000, HACCP (21 CFR 120) 3
A Information on good laboratory practices (GLP) for the non-medical or food industry wanted Manufacturing and Related Processes 1
S FDA Registration food facility - We operate under CGMP guidelines US Food and Drug Administration (FDA) 0
M FDA News USFDA Final Rule – Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures Medical Device and FDA Regulations and Standards News 0
I Food Contact Materials Declaration of Compliance Inquiry - (EC) 1935/2004 Food Safety - ISO 22000, HACCP (21 CFR 120) 4
Marc Interesting Discussion We have food safety laws thanks to 19th century “poison squad” Food Safety - ISO 22000, HACCP (21 CFR 120) 1
P SQF Food Safety Plan 8th Edition Food Safety - ISO 22000, HACCP (21 CFR 120) 0
T Value Chain Map for Food Services Industry Service Industry Specific Topics 1
Marc Food Processors and Blades - Weekend Discussion After Work and Weekend Discussion Topics 12
K Food Shelf Life Stability Study Statistical Analysis Tools, Techniques and SPC 1
P Customer Complaint Definition - Food Distributor Customer Complaints 5
Marc Food Safety Information Resource Food Safety - ISO 22000, HACCP (21 CFR 120) 0
O CFDA (China Food and Drugs Administration) Audit Finding Classifications China Medical Device Regulations 1
C Liquid Food Grade Transportation Requirements Supply Chain Security Management Systems 1
R Personalised Food Packaging Training - Internal, External, Online and Distance Learning 2
R Polypropylene Packaging for Food items Design and Development of Products and Processes 2
S Food Safe Ink for reusable and disposable gloves US Food and Drug Administration (FDA) 2
S Korea - MFDS (South Korea Ministry of Food and Drug Safety) Contact? Other Medical Device Regulations World-Wide 4
D Requirements for Storage of Food Allergen Ingredients Manufacturing and Related Processes 1
J CFDA issues Guiding Opinions on Enhancing the Construction of Food and Drug Inspectio China Medical Device Regulations 1
0 Standard that is the equivalent to ISO 22000 but for the non-food industry Food Safety - ISO 22000, HACCP (21 CFR 120) 7
F Implementing ISO 9001:2008 in a new Food Processing company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Chennaiite Is Audit of Employee Canteen Food within the scope of OHSAS 18001? Occupational Health & Safety Management Standards 17
P ISO/DIS 9001:2015 Vs ISO 9001:2008 in a Food Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Marc Thoughts for Food - What's on the menu? Coffee Break and Water Cooler Discussions 3
S Does Contract Manufacturer need to issue Food Grade certificate for finished device? US Food and Drug Administration (FDA) 1
V Is it required to perform Process Validation for food or dietary supplements? Food Safety - ISO 22000, HACCP (21 CFR 120) 4
D Pesticides in Food Process Areas - HACCP in a Restaurant Food Safety - ISO 22000, HACCP (21 CFR 120) 1
H Microbiology Criteria for Food Packing Material Food Safety - ISO 22000, HACCP (21 CFR 120) 5
0 GMP Guideline for Recycled Plastic Flakes used in Food Applications Quality Manager and Management Related Issues 4
AnaMariaVR2 Getting Importers? Pulse About Food Safety Plans Food Safety - ISO 22000, HACCP (21 CFR 120) 3
T ISO 9001 for a Holding Company which owns several Food Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T Food Safety Manual for ISO 22000:2005 - Please critique Food Safety - ISO 22000, HACCP (21 CFR 120) 2
Marc Definition Sell By, Use By and Best Before - Food Label Content Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
K It's 2013. What are your Food Safety System concerns? Food Safety - ISO 22000, HACCP (21 CFR 120) 8
P Food Hygiene Presentation Training - Internal, External, Online and Distance Learning 0
M Determining Critical Control Points (CCP's) in Food Safety Food Safety - ISO 22000, HACCP (21 CFR 120) 4
P Food Contact Surfaces presentation # 2 Training - Internal, External, Online and Distance Learning 1
P Food Contact Surfaces Presentation Training - Internal, External, Online and Distance Learning 0
P Food Safety & Technology presentation Training - Internal, External, Online and Distance Learning 1
M Critical Limits for CCP in a food storage warehouse Food Safety - ISO 22000, HACCP (21 CFR 120) 4
Y Delivering an effective and all inclusive EHS program in a Food company Food Safety - ISO 22000, HACCP (21 CFR 120) 2

Similar threads

Top Bottom