Records management – part 2

The standard…. “4.2.4 Records are established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.  Records remain legible, readily identifiable and retrievable.  A documented procedure has been established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.”

So the first thing you must know for a quality management system is that you must have a documented procedure for this element.  Full stop.  If you don’t have one or at least have the above requirements addressed in a merged procedure’ then you are non compliant.  So the procedure must address each of these; identification, storage, protection, retrieval, retention time and disposition of records.  Notice there is no prescription behind these requirements.  That is up to you.  You can address the requirements in each process or procedure or you can develop a matrix or table and describe these controls.  There is no right or wrong way in managing records.

The only real tricky component here is the statement concerning “Records remain legible, readily identifiable and retrievable.”  This may require some training, some discipline, some practice.  Just remember, that ‘I can’t find them’ is no defence in either quality management systems or tax audits.  So a few dummy runs on retrieval and readability is a great course of action especially if you are relying n computer data.  Now where does that 5¼” floppy disk get inserted into my server?  Hmmmmm.

previous blogs;
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