Hi friends, can anyone show me an example of a procedure for ISO 13485 6.4.1 Work Environment?

[FloridaST]

We need to do a better job at covering 6.4.1 Work Environment, specifically the requirement for evidence of procedures for health/cleanliness and clothing. I'd like to tie this in to our Preservation and Handling which does cover clothing and contamination of product so it may be a good fit here. Would this be advisable or should I create a separate document? Either way, would anybody have an example I can look at for inspiration? Thank you.

 

[yodon]

There's no requirement for a "procedure" - you just need to document the requirements. You could document the requirements in the Preservation and Handling SOP a long as you're covering all work areas.

 

[FloridaST]

There's no requirement for a "procedure" - you just need to document the requirements. You could document the requirements in the Preservation and Handling SOP a long as you're covering all work areas.

Thanks for clarifying, I focused on the words the auditor used and he mentioned "procedure" so I took it at face value without confirming in the standard.

 

[Gilleal]

We need to do a better job at covering 6.4.1 Work Environment, specifically the requirement for evidence of procedures for health/cleanliness and clothing. I'd like to tie this in to our Preservation and Handling which does cover clothing and contamination of product so it may be a good fit here. Would this be advisable or should I create a separate document? Either way, would anybody have an example I can look at for inspiration? Thank you.

Hi - wondering if you have an example of what you documented for health requirements?

 

[Hi_Its_Matt]

I'll throw my 2c in. I recommend you read carefully the requirement of 6.4.1.

(emphasis mine)

6.4.1 Work environment
The organization shall document the requirements for the work environment needed to achieve conformity to product requirements.

IF the conditions for the work environment can have an adverse effect on product quality,
THEN the organization shall document:
1. the requirements for the work environment AND
2. the procedures to monitor and control the work environment.

The organization shall:
a) document requirements for health, cleanliness and clothing of personnel IF contact between such personnel and the product or work environment could affect medical device safety or performance;
b) ensure that all personnel who are required to work temporarily under special environmental conditions within the work environment are competent or supervised by a competent person.

This means you must first understand (1) what the product requirements are, and (2) how the work environment can impact the ability to meet those requirements.

If it is a requirement that the product be provided sterile, then that means controlling the cleanliness of your manufacturing environment to a certain level, such that you have consistent product bioburden levels, and can validate your sterilization process.

If even the smallest amount of contamination can have an adverse effect on product quality, then you may require that employees not come to work if they are feeling sick, and be temperature tested before every shift [health]. You may require that they shower before entering the manufacturing floor [cleanliness]. You may require that they wear a fully protective suit - smocks, gloves, goggles, respirator, etc [clothing].

If some amount of bioburden is acceptable, then maybe you don't need the temperature check, and maybe hand washing instead of showering is sufficient. Maybe instead of the protective suit, you let people work in their jeans and t-shirt. It all depends on what is needed to achieve product requirements.

Once you know what the necessary work environment requirements are, document them. Then you document the controls necessary to make sure that you consistently meet those requirements. Whether you do it in a "Preservation and Handling" procedure, or in some other location doesn't really matter. As long as the controls are implemented and effective, and your work environment continues to meet its requirements, you should be good.