Document Control Pitfalls: 5 step Approach.
Venkat Kiran Bavirisetti
Solid state Research Scientist/Registered Patent Agent
Document Control Pitfalls: 5 step Approach.
Document control alludes to methodology for endorsement, dispersion, and change of a report and the assignment of an individual or individuals to execute those strategies.
Document control comprise the following five intermediate steps:
·????????Document Creation?
·????????Approval?
·????????Change Control?
·????????Retrieval
·????????Obsolescence?
Step 1: Document Creation
Documents creation effort is Team effort comprising of two or more departments, coordination between them is essential for quality document. Further creation of documents is cumbersome, tedious and time consuming. Report creation quite often requires joint effort, which could be tedious without the proper devices and a compelling framework.
Stage 2: Document Approval and Distribution
Postponements can make the cycle come to a standstill. This occurs if the cycle depends on the presence of approvers/reviewers and it doesn't give a component to deal with their nonattendance.
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Apparition of updates/ revisions past haunts users. This happens when old modifications are uncontrolled and continue to keep on surfacing.
Employee awareness and updating Training can be forgotten and get lost in noise. This is bound to happen if after document is approved, then necessary training to its related employees is not triggered.?
?Stage 3: Review and Change Control
Document control can be ignored. This happens document preparation cycle fails to integrate a standard review to ensure that a document is still applicable and updated after certain period.
Documentation is Team effort comprising of two or more departments, coordination between them is essential for quality document. Ensuring the right people are involved in every step is a big challenge.
Stage 4: Retrieval?
Endorsed documents must be easy to track down and cited. Else they were of no use, it should easily available to the concerned persons for reference.
Stage 5: Obsolescence?
Quality Assurance department should have proper archival maintenance policy. Retention of documents will be ineffective if a well-designed retention policy is not put in place and enforced.
Audit, Inspection and Regulatory requirements will direct organization retention time periods. Further organization’s Archival maintenance and retrieval policies should be based on risk-based approach to ascertain sensible document retention periods for various types of documents.
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