Change, effectively managing audits

Worksite analysis involves a variety of worksite examinations, to identify not only existing hazards but also conditions and operations in which changes might occur to create hazards. Lack of awareness of a hazard, stemming from failure to examine the worksite, is a sign that safety and health policies and/or practices are ineffective. Effective management actively analyzes the work and worksite, to anticipate and prevent harmful occurrences. This requires periodic examination of the workplace through inspections, audits, and the application of other safety tools such as the job safety analysis. 

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. 

The management system is owned by and is the responsibility of the top management, ft is incumbent on the management to review the overall effectiveness and currency of the system and the range of services offered by the laboratory. This should be done annually, and should include input from internal audits, clients, staff, and quality control records. The review should also consider supplier performance, wider management issues, and any changes that have affected the laboratory. The review should be used to... 

The agenda of the management review meetings is based on follow-up actions from previous reviews, proposed and planned changes to inculcate further improvement, customer feedback resulted through effective communication and results of the previous audits, and the corrective and preventive action taken. 

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. 

A second type of internal audit or inspection, usually termed a review, is a check by senior laboratory management to ensure that the quality system is effective and is achieving its objectives, and to identify opportunities to improve the system. Over time, client requirements and the needs of the laboratory are likely to change, and the quality system must be sufficiently flexible to allow continuous evolution to fulfill its purpose. Reviews are typically carried out by management on an annual basis, and are coordinated by the laboratory quality manager. Many different... 

Documentation controls apply to system development and maintenance as well as to use. Development practices and procedures need to documented according to a Quality Management System (QMS) [4] and controlled in the same way as other GxP documents. Of particular importance is the establishment of an audit trail for documentation and management of change control and the associated records. The FDA needs to be able to establish unequivocally which version of software was running on what equipment, at which time, when every record was created. One of the effects of this rule is clearly to bring the IT Department, traditionally seen as being on the periphery of GxP, firmly within the fold ... 

Top management shall review the quality management system at prescribed intervals to ensure its continuing effectiveness. These reviews shall include results of audits, customer feedback, process performance and product conformance, status of corrective and preventive actions, and changes that could affect the quality management system. 

Part of the committee s responsibility should be to monitor the effectiveness of the SMS (see Sect. 8.7.2) and identify any shortcomings or inefficiencies. Changes to the system should be managed through the committee to identify potential impacts. The meeting should be accurately minuted (preferably by a dedicated minute-taker) and the minutes distributed after the session for agreement. This document should then be archived and be available to be called upon in any audit which may subsequently be undertaken. 

Hazards noted, physical or operational, are to be viewed as being representative of possible deficiencies in management systems. A management that wants to achieve a change in culture is best served if the deficiencies noted and the proposals made in audit reports for improvement principally effect safety management systems. 

In addition to the change control tracking system, there should also be some formal system to periodically review and audit the management of change program for effectiveness and continuous improvement. 

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