Rank: Guest 
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Posted By Brian Eddington
We have a Quality Assurance member of staff who has produced a quality manual.... This has gone for review but in my H&S role should I have studied this in great detail (GLP Regs 1999 fall under H&S)... and will it fall on my shoulders
Thanks in adavance
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Posted By Ron Hunter
Not being cheeky, but I think we all get better communications if we avoid these 'less well known' abbreviations !
Take it you mean the Good Laboratory Practice Regulations 1999, made under the European Communities Act?
Not sure then of your reference to "falls under health and safety"?
OK, very much a health angle, given the Regs enforced by GLPMA (there you go, I'm doing it to), a body established by the Secretary of State for Health, and comprising people from health backgrounds - but what's your question?
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Posted By John Donaldson
Brian,
If I have understood it correctly the Good Laboratory Practice Regulations where produced to ensure that the testing of chemical substances was being carried out following documented procedures and the application of good science and that such activities were audited. Hence your colleagues QA manual
They came about from an EU Directive.
Its not really about safety although it does get a mention.
The regs are enforced by the Good Laboratory Practice Monitoring Authority not HSE.
Its probably worth a look just to ensure safety does get a mention.
Unless you have an auditing function outside of safety it possibly will not fall to you.
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Posted By Sean Fraser
Ron, I hadn't been sure what the GLP Regs were so I checked separately with Brian and then had a glance over them through the HMSO website, as we have a oil & gas sample analysis lab and I needed to understand what these were in case they applied to us. They didn't, but I did notice that they were headed "Health and Safety" so I made sure before disregarding them.
To my mind the question was whether the Quality Assurance Programme automatically included H&S activities - the intention of the Regs are slightly blurred in this respect although my interpretation has been that the GLP is aimed at ensuring practices are robust enough to consistently provide accurate data as required. The use of that data may, but may not, be used to formulate regualtory policy and governmental action in the area of human health or the environment.
Although there doesn't appear to be a direct link, I would have thought that good sense (good practice?) would be to ensure the Quality Manual has been reviewed by those affected by it, at least the senior managers, and especially if it is written to incorporate both H&S and environmental management activities (integrated management systems, as it were). However, if you are to take this up with the QA dept. Brian I would think it would be an internal matter, not one required by the statute.
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Posted By Ron Hunter
I suppose the upshot to this discussion thread is that as professionals we shouldn't be "working in silos". A TQM (Total Quality Management) approach across all company activities will involve the successful integration of H & S , environmental, quality and other systems.
So yes, as the health and safety adviser you should be aware what the quality department are up to and how their policies and procedures 'fit'; but bear in mind that for successful TQM, this has to be a two-way process. Those with the Quality remit should be liaising with you to make sure their proposals fit with company H & S Policy and practice!
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