Compliance procedures, management systems

Introduction Review and audit processes are used in the chemical process industry to evaluate, examine, and verify the design of process equipment, operating procedures, and management systems. These processes assure compliance with company standards and guidelines as well as government regulations. Reviews and audits can encompass the areas of process and personnel safety, environmental and industrial hygiene protection, quality assurance, maintenance procedures, and so on. 

The following documents and records should be reviewed as appropriate, and observations noted. Some of these documents may not be available as they can contain proprietary information for other clients. Place emphasis on determining whether the toller has established procedures and a management system adequate to ensure ongoing compliance. 

The general purpose of an audit may be to determine if the toller has management systems and documented procedures in place to ensure process safety, environmental responsibility, product quality and traceability of materials. The need to audit could be to evaluate compliance with regulations or accordance with client requirements related to specific performance elements. A subjective rating system for ranking management systems audit results is often used. An example of one that might be appropriate is shown below ... 

All quality system procedures and instructions are implemented to ensure effectiveness of the quality management system. To ensure continual improvement, facilities, equipment, and documents are reviewed and approved for implementation. The compatibility of the process with the production facilities and infrastructure is ensured to achieve product realization in compliance with the customer requirements. The implementation is achieved through ... 

The QAP should describe responses and corrective actions when laboratory performance levels are out of compliance. All samples identified in the report as processed by out-of-compliance procedures, systems, or analysts must be considered potentially deficient. Appropriate deficiency report forms need to be issued to inform the pertinent analysts, operators, supervisors, and managers. In some instances, a sample that does not meet general QA criteria nevertheless may be acceptable for the intended application, e.g., a measured value is well below the permissible level although its uncertainty exceeds specifications. 

Procedures for the prompt and appropriate correction of any violations, and any necessary modifications to the. .. compliance management system to prevent future violations. 

Safety audits are systematic procedures for reviewing management systems and practices implemented to achieve safety. They can include a compliance review, similar to a safety inspection. The audit process also allows for reviewer suggestions and recommendations for improvement. Audits may be part of more general practices to ensure that management systems are in place and followed as written. Audits can apply to systems, processes, products, programs, or services. 

The Health and Safety at Work etc. Act (HSW Act), 1974, instituted a system of enforced self-regulation which placed primary responsibility for health and safety with industry. It charged companies with risk management responsibilities which ideally involved companies in developing risk management systems and rules to secure compliance and also entailed worker participation (Ch. 6). But, as Dawson et al. (1988 44) warn, the creation of health and safety structures and procedures within a company is an imperfect measure which does not in itself indicate an improvement in health and safety. Indeed their own case studies demonstrated that compliance with the formalities did not necessarily indicate a serious and established concern to improve standards of health and safety (1988 87). There is therefore a need to consider the impact of these structures in terms of the difference they make at an everyday level. As Stone (1975) comments, the key task is to make bureaucracies think like responsible individuals, so the systems and decision-making processes they institute are critical. 

Compliance and risk management systems, rules, and procedures are seen as a normal and necessary part of routine corporate life... 

OSHA encourages employers to implement and maintain a program that provides systematic policies, procedures, and practices that are adequate to protect employees from safety hazards. In other words, an effective system identifies provisions for the systematic identification, evaluation, and prevention or control of workplace hazards, specific job hazards, and potential hazards that may arise from foreseeable conditions. Compliance with OSHA standards is an important objective. However, if you develop a successful management system, this becomes a non-issue. 

The organization would show evidence of both audits and reviews of the procedure in order to claim compliance. Compliance with ISO 9001 is strongly indicated if one is aiming to claim functional safety compliance. The life-cycle activities are so close to the ISO 9001 requirements that it is hard to imagine a claim which does not include them. The ISO 9001 quality management system would need to be enhanced to include ... 

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