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

[Harold]

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.

[HFowler]

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]

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.

[Alf Gulford]

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

[tomvehoski]

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

[Randy]

For OSHA check 29CFR 1910.1200 Hazard Communication (Fed anyway)