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Non-conformity – not following a procedure

Non-conformity – not following a procedure

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...
Procedure or documented procedure?

Procedure or documented procedure?

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...
Documents required by USA GMP (21 CFR 211)

Documents required by USA GMP (21 CFR 211)

The article covers the requirement of written procedures required by 21 CFR 211.  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...
Documents required by ISO 9001

Documents required by ISO 9001

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...
Documents required by EU GMP

Documents required by EU GMP

The list below details the documents required by EU GMP  as “documented procedures”.  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...