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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