Work Environment - Which of the following is to be addressed as nonconformity?

[quality-one]

Hi everyone

I have conducted an audit of a Plastic bag / pouch and food packaging company today.

As some of you know I am involved in pharmaceuticals sector, but our supplier is manufacturing us some of the PE- based pouches and bags.

They are ISO-9001:2000 and BRC-IOP certified.

When conducting the manufacturing facilities during the audit I came across a huge field equipped with machineries. They use some chemicals such as solvents but no adequate ventilation.

But I hope my knowledge does not deceive me ISO states that Management should provide appropriate working environment. In brief should I raise a non-conformity about this matter.?

Who could reply me? I would appreciate.
Thanks in advance

 

[potdar]

Re: Which of the following is to be addressed as nonconformity?

Hi everyone

I have conducted an audit of a Plastic bag / pouch and food packaging company today.

As some of you know I am involved in pharmaceuticals sector, but our supplier is manufacturing us some of the PE- based pouches and bags.

They are ISO-9001:2000 and BRC-IOP certified.

When conducting the manufacturing facilities during the audit I came across a huge field equipped with machineries. They use some chemicals such as solvents but no adequate ventilation.

But I hope my knowledge does not deceive me ISO states that Management should provide appropriate working environment. In brief should I raise a non-conformity about this matter.?

Who could reply me? I would appreciate.
Thanks in advance

I think your query would it in some other thread, but anyway - ISO 9001 is a product centric standard. The work environment requirement - just as everything else - talks of the environment required to ensure conformity to product requirements. The situation you describe wouldnt qulify as an NC on this account.

By the way, are auditing this suplier for ISO 9001 or for something else?

Coming back to ISO 9001, if the situation violates any requirements which you have specified as a customer, or any statutory requirements, then it could amount to an NC - but on different grounds.

 

[Helmut Jilling]

Re: Which of the following is to be addressed as nonconformity?

I think your query would it in some other thread, but anyway - ISO 9001 is a product centric standard. The work environment requirement - just as everything else - talks of the environment required to ensure conformity to product requirements. The situation you describe wouldnt qulify as an NC on this account.

By the way, are auditing this suplier for ISO 9001 or for something else?

Coming back to ISO 9001, if the situation violates any requirements which you have specified as a customer, or any statutory requirements, then it could amount to an NC - but on different grounds.

The standard does not provide much to go on, on this topic. Customer requirements might address the work environment.

The standard has clauses which deal with regulatory issues to a small degree (you can reference cl 0.1, 1.1, 1.2, 5.1, 7.2.1, 7.2.3). But, it does not give you a great deal.

 

[Sidney Vianna]

Re: Which of the following is to be addressed as nonconformity?

But I hope my knowledge does not deceive me ISO states that Management should provide appropriate working environment.

Your knowledge did deceive you because, apparently, you stopped reading the sentence half way.

 

[harry]

The above four posts were moved from the thread: What are your 'Quality Objectives'? to form this new thread.

 

[Ajit Basrur]

Hi everyone

I have conducted an audit of a Plastic bag / pouch and food packaging company today.

As some of you know I am involved in pharmaceuticals sector, but our supplier is manufacturing us some of the PE- based pouches and bags.

They are ISO-9001:2000 and BRC-IOP certified.

When conducting the manufacturing facilities during the audit I came across a huge field equipped with machineries. They use some chemicals such as solvents but no adequate ventilation.

But I hope my knowledge does not deceive me ISO states that Management should provide appropriate working environment. In brief should I raise a non-conformity about this matter.?

Who could reply me? I would appreciate.
Thanks in advance

Sorry, I didnot know that you were involved in Pharmaceuticals.

I would raise a NC as non compliance to point 6.4 - Work Environment. Probably, you should have a look at CEFIC Guidelines for Use by the Chemical industry which states the following -

The work environment must be conductive to maintaining conformity of
the product to specification. For example, clothing which eliminates
product contamination, filtration and dehumidification equipment to
maintain appropriate atmospheric conditions should be considered.
Product contamination can occur from a variety of causes, including
improper tools, poor work instructions or inadequate cleaning practices.
These risks must be identified and minimised or eliminated.
Additionally, conditions in work areas (temperature, noise, humidity, smell, exposure to chemicals) should be such that the performance and health and safety of the personnel will not be detrimentally affected.

Full account should be taken of regulatory requirements.

 

[somashekar]

I would ask to visit your supplier evaluation and selection process and find out what product requirements have been defined. I would also ask for what processes this part undergoes in your plant to ensure that end product requirements are satisfied. I Obviously feel you pack your products in the supplied pouches and bags in which case your concern is valid. Did I get you right ???
Somashekar
INDIA

 

[Jen Kirley]

You would need to find a "shall" somewhere, to avoid the argument that conformance to a guideline (such as the CEFIC Guidelines for Use by the Chemical industry) is optional.

While I searched for contamination potential of solvent vapors, I found this guideline to share: Environmental, Health, and Safety Guidelines for Pharmaceuticals and Biotechnology Manufacturing from the World Bank Group.

 

[AndyN]

They use some chemicals such as solvents but no adequate ventilation.

On what did you base this comment? What do you deem as adequate? Others here have correctly mentioned that the ISO 9001 requirement relates to environment which affects product quality - regulations (should) look after the safety of personnel.

You have to indicate (for us or in your nc statement) why you feel the ventilation is inadequate, otherwise it's simply opinion and that's not a good place to start from.

 

[Colin]

You would have to demonstrate that the work environment was preventing conforming product being produced. ISO 9001 does not cover health and safety - see section 0.4.