Management systems audits

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 ... 

Good The management systems audited provided reasonable protection against significant loss or noncompliance with regulations and directives. Any deficiencies found were deemed minor. Relevant management systems are documented and routinely followed. Some corrective action may be necessary. 

Needs Improvement The management systems audited provided limited protection from significant loss or non-compliance. Some required management systems may be... 

The team should be realistic about the time required to see improvements in end-of-pipe measures in most cases the pilot project success will be measured on efficiency improvements and other in-process measures alone. In this case it is important to demonstrate that all PSM and ESH issues are being managed. You should consider having a management systems audit (validation) conducted by a group independent of the integration project team. This may be done in conjunction with the next scheduled audit. This may be a corporate or divisional audit function or a consultant engaged specifically for this task. 

Formal acceptance of recommendations Assignment of a responsible individual Determination of action priority Implementation of actions Changes to the management system Audit trail Action tracking Sharing lessons learned Follow-up audit Incident trend analysis... 

A manufacturer must apply an appropriate conformity assessment procedure to their device in order to ensure that it complies with the essential requirements, after which they must certify this fact by completing a declaration of conformity. There is usually a choice of conformity assessment procedures open to a manufacturer, depending on a risk-based classification of the class into which the device falls. The two main approaches to conformity assessment are based either on an approved total quality management system audited to ISO 9000 series standard, as customised for medical devices with EN 46 000 series standard, or individual product assessment. 

International Organization for Standardization (ISO), (2002), Guidelines for quality and/or environmental management systems auditing, ISO 19011 2002, ISO, Geneva. 

An audit organization is an organization that regularly conducts quality assurance management system audits to a required standard. 

Final Good Manufacturing procedure / Quality Management System audit... 

How and why are sustainability audits different from environmental, health and safety (EHS) audits or management system audits ... 

Boundaries or Scope. Compliance audits, management system audits, and early sustainability audits all generally measured activities based on the traditional... 

So, what are the conclusions looking at established management system audit results such as ISO 14001, new approaches, and even the inclusion of security as part of the recent certification audits to the American Chemical Council s (ACC) Responsible Care Management System (RCMS) and RC14001 Technical Specifications ... 

International Organization for Standardization, Guidelines for Quality and/or Environmental Management Systems Auditing (ISO 19011 .2002(E)), International Organization for Standardization, Geneva, Switzerland, 2002. 

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