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Posts tagged ‘Documents’

Non-conformity – not following a procedure

October 17, 2012

Dominic Parry

A common finding when auditing is discovering that the organisation or department that you are auditing is not following their own internal procedure or policy.  This is a non-conformity, and should be raised as such.  The problem is – what clause of the standard actually states that you should follow your procedures?  On investigation this is not as easy to find as you might like to think! Read more

Procedure or documented procedure?

September 25, 2012

Dominic Parry

In many standards that exist there are often statements such as “there must be a procedure to control training records”.  Whilst I am sure that none of you will disagree with a statement such as this there is an element of unclarity in the statement itself.  It surrounds the use of the word procedure and what is meant by a procedure.  Read more

Documents required by USA GMP (21CFR211)

March 9, 2012

Dominic Parry

The article covers the requirement of written procedures required by 21 CFR211.  As with the similar blog articles on documents required by EU GMP and ISO 9001 the reader should note that the words “written procedure” are not the same as “procedure”.  The word “procedure” is mentioned many times in GMP, but strictly speaking an activity only needs to be formalised into a controlled document if the words “written procedure” exists. Read more

Documents required by ISO 9001

March 2, 2012

Dominic Parry

The ISO 9001 standard is the international standard for Quality Management Systems.  During its review in the late 1990 they removed its “obsession” of needing a documented procedure to cover most tasks.  This is because organisations vary in size and complexity, and it may not be necessary to control an activity via an approved procedure.  There are many things that we do in life every day that are not subject to a formal procedure, yet we do them without any problems.

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Documents required by EU GMP

February 24, 2012

Dominic Parry

The following lists the specified documented procedures required by EU GMP.  It is worth pointing out that many times in GMP there is a requirement to have a “procedure”, but this is not the same as a “documented procedure”.  There are many activities that you do that are “procedures”, such as how you get in the car in the morning (unlock the door, adjust the seat, fasten seat-belt, start the engine, and so on), but this is (hopefully) not a “documented procedure”!  “Documented procedures” are often referred to as Standard Operating Procedures (SOPs), but they do not have to be called these.

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