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How to implement 4.2.4 - Disposition of Records in Electronic Files

B

berseak

#1
How to implement 4.2.4 disposition of records in Electronic File and show audit for this item.

Thank you in advance.
 
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qusys

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#2
How to implement 4.2.4 disposition of records in Electronic File and show audit for this item.

Thank you in advance.
It is a matter of your documented procedure for record control, so it is up to the organization. As a suggestion, from my experience and working on this item to be shared with you, you as an organization shall indentify the records ( in whatever fashion) for your QMS and set a retention time, taking into account customer requirement, legal and statutory requirment and internal one. You can think to set the term " at least X years" to be safe. Consider that for electronic and paper file ( or documents) you shall invest resources, so to be effective you shall optimize costs. Given that records control is a cross activity on your QMS processes , you can think to audit this item during internal process audit on how and if the documented procedure is met. This can be done at sampling on specific items. This could be a good method given that this demonstrated the so called "process approach" stated in ISO 9001.
In alternative way, you can also think to audit internally the compliance to the procedure stating this in the scope and criteria of the audit, focusing only on this topic.
Besides, if you have established the records control as a process of your QMS, you can check at its KPI and this could be a direct method to check the fullfilment of the requirements of the organization.
Hope this helps.:bigwave:
 
#3
How to implement 4.2.4 disposition of records in Electronic File and show audit for this item.

Thank you in advance.
It is going to depend on what the records procedure says. Any audit should - in principle - be an audit of the QMS (documented procedure in this case). To audit "disposition" for electronic files is really about how they are treated once they have been used for analysis purposes. For example, moved to a different file/directory/drive etc. Maybe archived on a different drive and stored off site. Maybe deleted completely. These are dispositions, which shouldn't be confused with "disposal".
 
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