Change, effectively managing documentation

Change Approval - All organizational (MOOC) changes shall be approved by the facility manager or documented delegate prior to implementation. Personnel changes may be approved by the supervisor and this approval can happen after the change effective date. 

The audit team, through its systematic analysis, should document areas that require corrective action as well as where the process safety management system is effective. This provides a record of the audit procedures and findings and serves as a baseline of operation data for future audits. It will assist in determining changes or trends in future audits. 

Reviewing the system by establishing appropriate accountability systems within the organization to monitor and report quality data and system status to management and assure that appropriate corrective and preventive actions are taken in response to quality problems using effective change control procedures and documented... 

Common sense and the OSHA Chemical Process Safety Management Law requires an audit of compliance to the Management of Change. Periodic review and documentation of a sites activities in managing aspects of personnel and process safety is often a part of an organization s culture. A good audit can measure the actual versus intended effectiveness of various programs. 

Computer validation should not be undertaken unless fundamental validation controls have been fully understood and implemented within the pharmaceutical or healthcare company s organization. Here we allude to properly qualified personnel, effective document management and change control systems, internal audit procedures, methods of managing the deviations from standard practice thereby exposed, and a culture of continuous improvement (see Chapter 4 for more details). Senior management must not fall into the trap of assuming through complacency or idleness that these controls have been fully instituted In most firms there is usually much that still needs to be done in these areas. Let us examine these controls a little more closely. 

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