Documentation and its Management

Medicinal products must be fit for their intended use, comply with the requirements of Market Authorization and not place patients at risk because of inadequate safety, quality or efficacy. These objectives are easy to state, but to achieve them requires a comprehensively designed and correctly implemented system of quality assurance. It is important that this is documented and its effectiveness monitored. Records must be kept that are open to inspection by validating bodies, and there must also be procedures for selfinspection and quality audit that allow appraisal of the quality assurance system. Management must be adequately trained and their responsibilities minutely defined. Two key posts are the Heads of Production and of Quality Control. These posts are required by the guidelines to be independent of one another. 

The actual path that various documents must follow in the organization may or may not be fixed in a paperless operation, but it must be decided whether workflow automation is within the scope and, if so, how it should be implemented. Again, it is different from the paper-based world in that such definitions will not just be for specific persons or specific documents but on the roles of the persons and on the categories of documents. Possible workflow paths for the various document types and document phases will also need to be decided. Paperless operation may be achieved without tying electronic documents and their management to a workflow. When doing this, it is important to retain flexibility. 

Two of the key factors to be addressed when introducing the ISO 9000 initiative are developing a customer-focused culture and teamwork. These factors are often not given sufficient attention during the implementation of the ISO 9000 system. This can result in a static management system rather than one which is dynamic and responsive to market demands and competitive pressures. For a very extensive discussion for an effective implementation of the ISO 9000 standards, see Refs. 2 and 3 for a thorough discussion on documentation and its proper implementation, see Ref. 5. 

Organizing The employer and its management should allocate responsibility, accountability, and authority for implementation of policies, applicable procedures, and safety and health objectives and plans. The employer should ensure competence and training for all who participate in SMS. The SMS must include organized and effective documentation and effective communication both downward and upward in the organization. 

Risk analysis is a live document and it should be thoroughly reviewed by the operator whenever there is any change in the system because it is the responsibility of the operator to understand all risks and control measures all the time. Also to improve the quality of risk analysis it is important to validate all hazards/major incident events, likelihood, control measures, and consequence, very rigorously. Proper communication, updating, and education/training are parts of risk management, which is an extension of risk analysis. So far helpful discussions have taken place regarding control measure, but what is control measure The next clause provides the answer. 

Disaster Planning. Plant managers should recogni2e the possibiHty of natural and industrial emergencies and should oversee formulation of a plan of action in case of disaster. The plan should be weU documented and be made known to all personnel critical to its implementation. Practice fire and explosion drills should be carried out to make sure that all personnel, ie, employees, visitors, constmction workers, contractors, vendors, etc, are accounted for, and that the participants know what to do in a major emergency. 

Documentation is important. Everything considered should be documented. If it is not documented, then you didn t do it. (Dowell, 1994, pp. 30-34.) The key to PHA documentation is to do it right away before it gets cold. Periodic follow-up is needed by management and safety professionals to confirm that all recommendations have been addressed. 

In order to verify performance of a given toller with whom a company has worked before, it is essential to document and understand their performance history in the five areas listed above. Good documentation of prior toller performance will allow a new engineer or new manager in charge of tolling projects to base their initial selection of candidates on accurate data. 

A signed statement by management without its approval to the quality system documented policies and procedures will indicate that it is not committed to honoring the policies and procedures. Managers need to approve the documents within the quality system that prescribe activities for which they themselves are responsible. This serves to demonstrate that they agree with the manner in which the policy has been interpreted and are prepared to provide the resources needed to implement the documented practices. 

Where an effective informal system exists and is followed, the issue is one of style, not substance. A facility or unit may have a strong safety culture and sound safety practices, but its managers lack the habit of form documentation, or simply don t think it is important. Assuming that safety performance meets applicable standards, you will probably assign cases like these a relatively low priority, compared with other noncompliance situations. Cases like these are also often the easiest to fix since the fundamentals are already in place, what s required is simply to formalize the informal system by preparing and implementing documentation procedures. 

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