Quality system models

Quality systems. Model for quality assurance in design, production and servicing etc. 14001/1994 BS EN ISO 9001/1994 9001/1994... 

BS EN ISO 9001 1994 Part I - Quality Systems - Model for Quality Assurance in Design, Development, Production, Installation and Servicing. London BSI. 

Quality systems - Model for quality assurance m design, development, production, installation and servicing. Previously BS 5750 Part 1 1987... 

The objective of this guidance is to describe a quality systems model and demonstrate how and where the elements of this model can fit within the requirements of the CGMP regulations. The philosophy being put forward is that quality should be build into the product, and testing alone cannot be relied on to ensure product quality. 

Management Responsibilities The FDA feels that a robust quality system model calls for management to play a key role in the design, implementation, and management of the quality system. 

This Chapter describes outlines and discusses the regulations applicable to the QA function and unit, structure, function, charter, and application of the unit in the pharmaceutical manufacturing environment. In addition, it discusses additional quality-related responsibilities that may result when manufacturers move toward a quality systems approach to quality that incorporates current quality system models to further improve quality and harmonize with international quality system requirements. 

The major elements of the quality system model described in the FDA s pharmaceutical QS guidance document are consistent with existing quality system standards. These elements are as follows ... 

Current quality system models assign management a major role in the deployment and operation of a successful quality system. In such systems, major management responsibilities include the following ... 

In the control of outsourced operations, the cGMP regulations require that the QU approve or reject products or services provided under a contract. Under current quality system models, the organization must follow a formal vendor qualification process to qualify outsource providers and verify through inspection or other appropriate means that the provider is capable of meeting the requirements of the organization. To comply with the regulation, these operations should be conducted by the QU. 

There is significant commonality between the requirements contained in current quality system models such as ISO 9001-2000 and the cGMP regulation requirements for manufacturing operations. The FDA has identified four major elements of a QS approach to manufacturing operations. These are identified and compared to the cGMP requirements in Table 3. 

Current quality system models call for audits to be conducted at planned intervals to evaluate effective implementation and maintenance of the quality system and to determine if processes and products meet established parameters and specifications. International standards provide guidance on auditing [13]. Audit procedures should be developed and documented to ensure that the planned audit schedule takes into account the relative risks of the various quality system activities. Factors that can be incorporated into a risk-based approach to planning audit frequency and scope include the following [6] ... 

Since current quality system models employ a systems approach, an audit checklist that is organized by subsystem may be helpful, as described in Table 5. The form would include appropriate document control information such as form... 

A corrective action is initiated to correct the cause of an identified nonconformity and to prevent it or similar problems from reoccurring. It may include initial and follow-up actions (e.g., conducted after root cause analysis). Current quality system models and the cGMP regulations emphasize corrective actions and require that actions be documented. Under current quality system models, preventive actions include actions taken in response to quality data to address the cause of potential nonconformities to prevent their occurrence. An effective CAPA system therefore includes both reactive and proactive components. The effectiveness of corrective and preventive actions should be evaluated using objective criteria when possible and the evaluation documented. 

Continual improvement is a requirement of existing quality system models such as ISO 9001-2000 in which the organization is required to continually improve the effectiveness of the quality management system through the use of the quality... 

Development (QS) working group mapped the relationship between cGMP regulations and various quality system models both internal and external to the FDA. Their result is a comprehensive model which allows producers seeking to implement their own quality management systems to quickly identify those aspects of quality systems which are, and are not, correlated with cGMP. 

ISO (1994b), Quality systems—Model for quality assurance in production, installation and servicing, 9002 (Geneva International Organization for Standardization). 

Company name) is in compliance with the requirements of an international standard ISO 9002 1994 quality system — model for quality assurance in production and installation. However, the second edition (ISO 9002 1994), together with ISO 9001 1994 and ISO 9003 1994, is cancelled and replaced by a third edition of the ISO 9001 2000 module. It constitutes a technical revision of these documents. The quality manual QM-3 is prepared in accordance with the corresponding changes specified in the third edition of ISO 9001 2000. 

ISO 9002 1994, Quality System — Model for Quality Assurance in Production and Installation... 

ISO (2000), ISO 9000 Quality Systems —Model for Assurance in Design, Development, Production, Installation and Servicing, and ISO 9001-3 Quality Management and Quality Assurance Standards — Part 3 Guidelines for the Application of ISO 9001 to the Development, Supply and Maintenance of Software, International Organization for Standardization, Geneva. 

The ISO 9001 Quality System—Model for Quality Assurance in Design and Development provides for quality assurance in the areas of design, installation, servicing, development, and production. It is useful primarily for companies that design and develop their own products. 

The ISO 9002 Quality System—Model for Quality Assurance in Production, Installation and Service applies to manufacturers, distributors, and service vendors whose products have been designed and serviced by a subcontractor. Such companies are exempt from design control requirements. Both ISO 9001 and ISO 9002 are directly applicable to cGMPs. The connection between the two independent systems is shown in Table 5. Except for language, shades of meaning, and stresses the documents are similar. 

The ISO 9003 Quality Systems—Model for Quality Assurance in Inspection and Testing, designed for testing laboratories and equipment distributors only requires conformance to final inspection and testing procedures. 

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