Documentation Control and Record Keeping

How did you handle document control and record keeping in the registration during your implementation?

  • Lucent Poland

    All business units, operating in Poland and dealing with Lucent Poland customer contracts participate in the Lucent Poland Business Quality Management System based on ISO 9001/TL 9000 standard. Each of the business units is the owner for its specific activity process and is responsible in creating the process with the appropriate interfaces (including solutions to the standard requirements). The set of processes created and described by all business units comprise a set of procedures required by requirement 7.1.C.1 of the TL 9000 standard. The procedure format style and all edition rules were developed earlier and communicated to all people concerned. All completed procedures are maintained on the Lucent Poland Intranet web page and are available in both Polish and English languages, to all Lucent world-wide employees. It allows for internal communication of process design and ownership also demonstrates to customers Lucent Poland's ability to manage its own processes in the Product Life Cycle (as required by the standard). One of the procedures should be devoted to Quality Records, where the quality records are listed (the most important; as per quality audit result, measurements submission confirmation, management review summary and dates, etc.) and show and name databases for keeping them maintained.

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  • AFC
    1. Anyone in the organization can be a document author.
    2. There is a designated format or template for authors to utilize.
    3. Document Numbering
    4. Master Document List Contains
    5. Hierarchy
    6. Document Review Process Consist of the Following
    7. Quality Check

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  • Lucent

    To determine the level of granularity of documentation and the scope and breadth, consider these factors:

    • First of all-document thoroughly what's required by the standard
    • Second of all-what's the best way to capture to share it (do we need to have a common method for something-and if I do-what's the best way to communicate it to people-usually it's documentation)-based on the needs of the business.

    For example, for someone to use a complex documentation tool, there needs to be in depth documentation on how to use the tool and its functionality. But for someone who tracks corrective action on manual spreadsheets, there is most likely much less granular documentation-possibly only a high level flow chart or maybe work of the process is passed along on a train the trainer kind of basis.

    Documentation and the need for it should be reviewed on a periodic basis. It is suggested that the company determine how often that needs to be.

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