Friday, October 28, 2011


Document related
·         Uncontrolled documents in the manufacturing floor- including illegibility, scribbling and mutilations
·         Procedure does not reflect the practice and vice versa.
  • Vendor base not being consistently updated with current revisions of drawings and documentation.
  • Current and Obsolete drawings being used simultaneously
  • Approved vendor list not updated regularly.
  • Critical process instructions not available at the place of use.
  • Instructions displayed in workplace found not under document control.
  • Unauthorised and undated hand-written changes made to procedure
  • Inconsistency in the revision status of same document at different places of use
 Product related
  • No clear identification of good and non conforming material.
  • Incorrect storage of materials.
  • Shelf life products not assessed periodically
  •  Over aged product in storage
·         Management related
  • Internal quality audits not carried out at specified intervals.
  • Actions minuted in the management review committee meetings  not followed up for
  • completion.
  • Product non-conformances at in-process stage not selected for corrective actions.
  • Internal quality auditors carrying out audits without formal training
·        Records related

  • Quality record  not legible
  • Improper indexing /storing of records
Solutions to the above lie in the following
  • Design simple and operable management systems- adopt KISS- Keep It Simple and Short
  • Bring in all the documents under management system purview- never have any procedure/template outside the system
  • Assign process owners and make them accountable for the process performance
  • Make the system user-friendly and comprehensive
  • Create, store and retrieve documents and record using soft copies and avoid hard copies as much s possible
  • Bring in a culture of adhering to systems by periodical training to users
  •  Provide leadership in system maintenance



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