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
- 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
- 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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