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  • support 12:48 am on September 27, 2010 Permalink | Reply
    Tags: best practices, CAPA system, , , , quality management system,   

    Using The CAPA System To Address Audit Findings 

    An important aspect of any quality management system involves communicating the results of quality audits and inspections to employees so that the same mistakes are not repeated.  It is important to do this systematically, so that the communication of lessons learned can be done more than once and that lessons learned aren’t lost over time.   As a best practice, many companies use their corrective and preventive action (CAPA) system to address audit findings and handle this communication methodically.

    Here is how it works:

    Once the audit is complete, an audit finding is entered on a corrective action.  The action is assigned for root cause analysis and once the analysis is done, the appropriate correction is selected to address the audit finding.  Then, an action plan is developed to prevent the root cause of the finding.  This discipline forces more effective analysis and problem solving.

    The important last step is to circulate the results of the analysis and the actions taken to other employees. This allows each employee to benefit from all of the analysis and problem solving effort.  Consider having frequent job huddles with affected employees where corrective actions are shared.  Other methods to consider include using a web portal for employees to view them or conducting “lunch and learn sessions.” Many different communication methods will work, but it is important to make sure that employees are made aware of the results of audits, inspections and other corrective/preventive actions.  You may want to combine several of these methods.  Studies have shown that in order to get a message across you need to put the information in front of individuals seven times!  Over-communication is the key!  For help with quality management best practices and questions, contact bclancy@bizphyx.com.

     
  • support 3:55 pm on March 19, 2010 Permalink | Reply
    Tags: , quality management system,   

    Do we have to discuss all the inputs at every management review? 

    All the items stipulated for management review in sections 5.6.2 and 5.6.3 must be reviewed during management review. However, depending on the frequency of your management meetings, you may not have current discussion regarding every topic.  For example, you may only need to note that no internal audits have been conducted in the prior period.  Review of the internal audit findings would be discussed at the next management review meeting after the internal audit.  You must be prepared to show when each topic of your management review was discussed and any resulting actions to your registrar auditor.

     
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