Bqms template guidelines: master list of documents



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Animal and Plant Health Inspection Service

Biotechnology Regulatory Services
Document Control: BQMS_Template Guidelines_4.2.3 Master List of Documents
Version:

3.0

BQMS TEMPLATE GUIDELINES: MASTER LIST OF DOCUMENTS

Effective Date:



10/01/2011



This document provides user guidelines for BQMS_Template_Form 4.2.3 Master List of Documents, which requires the use of Microsoft Excel. The template provided can be used as a tool to develop a comprehensive document and record control form that may satisfy the BQMS Standard requirement 4.2.3, Master List of Documents. This template form serves as a useful tool to organize relevant processes, procedures, records and other objective evidence that can be used to demonstrate conformance with BQMS Standard requirements.
Figure 1. is a snapshot of the columns on the main document status form page. The numbers above each column are references for this document to indicate the suggested information for each column.
1 2 3 4 5 6 7 8 9



Figure 1. Snapshot of main columns of master list of documents template
Column 1: references the BQMS Standard clause or sub-clause requirement.
Column 2: references a general description of the requirement (typically a statement extracted from the BQMS Standard).
Column 3: references the title of your organization’s internal document/form that satisfies the referenced BQMS Standard requirement. (Note: Your organization may have one or more document that satisfies any element of the BQMS Standard. Example: your organization may have a documented procedure and a form that satisfied section 6.2.2 of the BQMS Standard.)
Column 4: references the creation date of the document
Column 5: references the current revision effective date (Note: It is important to keep the current revision up to date.)
Column 6: indicates who was responsible for approving the document (Note: The acronym ‘QMR’ can be used or the actual initials of the person responsible for approving the document.)

Column 7: references the file location (internal/secure network drive, etc.)

Column 8: references any updates to the document/form

Column 9: provides a hyperlink to the file folder or path for the document (Note: it is important to keep these links up to date and live.)
Figure 2. Example of fields entered in the master list of documents template
Tab 2 (worksheet 2) is the master list of your internal documents/forms/records that may be used as objective evidence for BQMS audits. Figure 3 is a snap shot of example data in Tab 2.
1 2 3 4 5 6


Figure 3. Snapshot of Tab 2 from master list of documents template
When any changes are made to a referenced procedure, form, etc., Tab 2 is updated to reflect any changes.

  • Column 4, Effective date, should be updated.

  • Column 6, Updates/comments, should be updated to reflect substantive changes.

Tab 1 (worksheet 1) is linked to Tab 2 using a vlookup formula to automatically populate references to a given procedure/form/etc. for dates and comments. For example, if you make a change in the procedure for Regulatory compliance incident reporting and resolution, you would



  • Go to Tab 2 to find that entry (listed as number 44 in the first column),

  • Change the effective date,

  • Confirm the file location, and

  • Add a comment.

The vlookup is using the information in the Title column (Regulatory Compliance Incident Reporting and Resolutionhighlighted in green) as the key for the lookup.

Printed documents are uncontrolled Page of
(***For BQMS Program document control, this may be deleted by user. BQMS_Template Guidelines_4.2.3 Master List of Documents_v3.0)

Approval f:\signature\emj initials signature copy.jpg




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