Records Part-2

Pranay Kumar

May 7, 16

In the time of ISO audit we need to check the documents as an evidence or a record of implementation, whether it is correct or not.

Records Part-2

This article is posted by Advance Innovation Group student intended to help students or depth understanding about quality management system.

If you use data that you have generated yourself it does not need approval prior to use. If you issue data to someone else, it should be approved before distributing in a network database. If your job is to run a computer program in order to test computer or the program. You should be authorized to conduct the test and therefore your approval of the data is not required because the data has not in fact been issued to anyone else.

Document Amendments, Review, Maintenance and Accessibility

ISO / QS 9000 specifies the following practice of document and Data control as mandatory requirements for all documents created.

Document Amendment

“Amendment” refers to making changes to controlled documents, for which there is a procedure stated. This procedure should explain how changes are recognized within the document, how and when current revisions are identified and the number of revisions before a document is reissued. Some documents, such as drawings, procedures and specifications, that change often and, therefore, require revision levels.

DOCUMENT REVIEW

The standard requires that documents need to be reviewed. Reviews may be random or periodic. Random reviews are reactive and arise from an error or a change that is either planned or unplanned. Periodic reviews are proactive and could be scheduled once a year to review the policies, processes, products, procedures, specification etc. for continued suitability. In this way obsolete documents could be flushed out from the system. However, if the system is being properly maintained there should be no outdated information available in the user domain. Whenever a new process or a modified process is installed the redundant elements including documentation should be disposed of.

Accessibility

The access requirement addresses the ability to retrieve documents, records, forms and templates of quality records and should ensure that they are handled safely. You need to provide access to records for those individuals who are approved for such access and not to unauthorized personnel. For example security may be an issue within your company for specific records like employee appraisal forms which are usually located in the human resource employee file. Procedures should describe the roles and responsibilities of those who can access and those prohibited from doing so. If your system is online, access may be restricted by password. Additional security might require locking of file rooms, cabinets and use of sign-in and out logs.

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