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Module 2 - Document Control
Transcript of Module 2 - Document Control
How do we enforce Document Control
Submitting a new Controlled DocuModule 3ment
Amending an Existing Document Module Overview Mission 1 Mission 3 Start Optional Training Modules :
Quality Management In order to be able to achieve document control a company must systematically abide by the following :
Ensure that all processes are based on best practice
That new and amended procedures and other control documents are reviewed and authorised by senior management before issue for use
There is ownership of processes and associated procedures, work instruction and forms/templates by department managers
Each document is uniquely referenced and identified to its status by the Quality Management Representative (QMR) and introduced in a controlled manner.
Only current versions are available at the point of use. Obsolete old archived versions.
Documents of external origin are identified and their distribution controlled.
Documents that become obsolete are removed from use and where necessary retained for the purpose of audit, review and inspection by interested parties.
Uncontrolled electronic and printed copies should be removed from use.
The Amendment Record is updated whenever a change is made to a policy, procedure or work instruction Submitting a new controlled document 1 UP Mission 2 Introducing a new procedure
1. QMR: Open IMS00 and from the index of procedures allocate the next number prefixed according to the department in which the procedure is used.
2. Update the IMS00 to confirm the reference has been allocated.
3.Using the procedure template;
-Enter the procedure title in the header e.g. Customer Complaint procedure
-In the footer; add the document reference, number and version e.g. CPCS03v1
-Save the document using the procedure reference and title e.g. CPCS03 Customer Complaint procedure (saving the document in the relevant department folder)
-Write the procedure and save it to its filename at regular intervals during the writing process
4.When the procedure is complete; request the Stakeholder /Custodian to review what has been documented and confirm its approval (or make necessary changes to it and obtain approval).
5.On approval; update IMS00 to include the date on which the procedure was issued (approved).
6.Send an e-mail to the Stakeholder/Data Custodian to confirm the procedure is available for use (copy e-mail to Stakeholders that need to be aware of the new procedure. Module 2 : Document Control The Data Custodians constitute a body of knowledgeable users who function as trustees of the companies administrative information.
For each centrally maintained document or record, a director or departmental manager is assigned the authority for making decisions related to the development, maintenance, operation and access of the application and the data associated with that business function.
The Quality Department is responsible for ensuring the confidentiality, integrity, and availability of all administrative information that the company processes and stores.
Data Custodians have a responsibility to the company to ensure they grant access to data to only those who require that access to perform their job responsibilities.
The Data Custodian must be familiar with the data, and the methods for accessing that data for which they are responsible. He/she should know how this data is used with the business functions of the company. If for any reason the Data Custodian has a question of whether that position would require that access, they should feel free to interview the requester to verify that position does actually require that access.
The more sensitive data and/or the more robust accesses may always need an interview. The familiarity of the data will guide the Custodian to make the appropriate decisions for controlling data definitions and to ensure the data conforms to the consistent definitions over the life of the data. The Purpose of Document Control How do we enforce document control ? Data Custodians are delegated the responsibility for controlling company data within their areas. Their responsibilities include the following:
1.Controlling document content to ensure data conforms to consistent definitions over the life of the data.
2.Approving requests for access to company data submitted by authorised company personnel.
3.Reviewing access groups ensuring the folders accessible to them are appropriate and valid.
4.Monitoring the data to ensure current document control procedures are effective.
5.Help staff members trouble shoot problems they encounter with documents.
6.Make any immediate access changes, depending on the severity.
7.Provide audit reports as required for internal and external departments. Documentation - policies, process, procedures, work instructions, forms and records, all play a critical role in improving process capability,
It's worth differentiating between document control and document management.
Document management tends to focus on how to deal with the volume of documents in terms of access, searching, archiving, etc.
Document control has more of a focus on those documents that have longer-term significance to the organization. These documents usually require formal approvals and have a very specific purpose. Mission 4 Amending an existing document 6. Once agreed; the QMR will make the required changes.
7. If the change to procedure is such that it cannot be briefly described within the IMS Amendment Record; copy and paste the existing procedure into the obsolete folder (using the copy and paste method will ensure the hyperlink from IMS00 will remain fixed to the original document filename).
In the obsolete folder amend the file title to include ‘Obs’ at the start of the filename. Open the renamed file and at title row add the text (bold red-coloured font) ‘Obsolete, refer version X, issued dd/mm/yy initials’ e.g. Obsolete, refer CP01v2, issued 05/08/2011AJ and save the amended document.
8. Open the original document that requires amendment and make the necessary content change then; change the procedure reference to include the new version e.g. CP01v1 would become CP01v2, change the date of issue to reflect the date on which the procedure was amended. Save the amended version to its original file. Changes to an existing procedure
1. A request for change can be made by anyone within the Davy Liver Group.
2.Where a need for change is identified the person requesting the change should discuss the proposed change with the relevant Stakeholder/Data Custodian.
3. Once the Stakeholder/Data Custodian agrees the proposed change; the S Stakeholder/Data Custodian informs the QMR of the required change.
4. The QMR will review the proposal and give due consideration to other procedures as is relevant to the proposed change.
5. If a modification to the proposal is required; discuss it with the Stakeholder/Data Custodian and agree what change is to be made. 9. Open IMS00 and test the hyperlink to ensure the link to the correct document has been retained (if not; recreate the link).
10. On IMS00; change the issue date of the amended document to that shown within its footer.
11. At the foot of IMS00 change the issue date to that shown on the amended procedure. Save the amended IMS00 to its original filename.
12. Before closing IMS00; open the link IMS Amendment Record and enter the procedure reference under ‘Ref’ enter the page number under ‘Page’ and record a brief description of the changes made (if the changes were such that the previous version was saved as an obsolete document; make reference to this when providing the brief description). Under the heading ‘Date’; enter the date as shown on the amended procedure. Save the amendment record to its original title.
13. Close the saved IMS00. GAME OVER
Introducing new forms and templates
1. Forms and templates are treated in the same way, regardless of whether the document is a form or template.
2. The same procedure is followed as that for introducing a new procedure: replacing references to IMS00 with Controlled documents – forms register and replacing document references with controlled document prefix ‘CD’.
3. A record of CD amendments is not kept; though documents prefixed CD are copied into the obsolete folder as and when they become obsolete. Introducing a new work instruction and recording amendments to them
1. The same procedure is followed as that for introducing a new procedure; replacing references to IMS00 with Work Instruction Register and replacing document references with work instruction prefix ‘WI’.
2. Amendments to WI prefixed documents will be recorded on the amendment record in the same way as that for documenting procedural amendments.