Quality management procedure

ISO 9000 requires what is called a third party assessment but involves developing first and second party strategies. First party refers to the supplier company that requests ISO 9000 certification. Second party refers to the customer whose needs have been met by the first party through the use of quality management procedures achieved by ISO 9000 compliance. Third party refers to an outside reviewer who certifies that the first party has satisfied ISO 9000 procedures. 

The overall project itself requires formally structured planning and control in addition to the validation plans for the computerized operation. To provide this, a project and quality plan from the pharmaceutical manufacturer (or its nominated main contractor) is normally developed as a separate and complimentary document and needs to overview all activities, resources, standards, and procedures required for the project. The plan should define project-execution procedures, quality management procedures, engineering standards, project program, and project organization (with authorities and reporting responsibilities), and reference the project validation plan. There are instances in which the project and quality plan and the project validation plan can be combined into one document. 

There are several reasons why a quality system must be fully documented. Firstly it is a pre-requisite of most quality standards. Secondly, in most laboratories it would be impossible to accurately remember and hence communicate all of the analytical methodology and quality management procedure to staff. This would lead to the quality system becoming compromised due to slalT turnover. Thirdly the process of audit (see Section 5.1) requires a precise definition of the planned quality system. This is provided by the documentation. 

Life-cycle approach Quality management Procedures Training... 

Source Code Reviews are used to ensure that controlled development and a consistent programming style have been used. It also checks GMP critical features. Source Code Reviews need a standard against which to check, and programming practices for all programs should be documented. An audit of the supplier s compliance with its own quality management procedures should have been carried out to ensure that appropriate quality is being built into the system. 

The establishment of a quality unit in the IT Department (or in small operations, a person, part of whose responsibility is quality), responsible for not only the GxP aspects of the IT operation but also other quality management procedures in IT, such as data security, access and control procedures, backup, archiving and restore, disaster planning and so on. 

The enterprise shall document and apply quality-management procedures for the development of products and life cycle processes consistent with established quality practices (see IKKK/EIA 12207.0-19% [B2]). 

The manufacture of sealed sources, devices and radiation generators should also be subject to the requirements of quality management systems such as ISO 9001 [37-39]. Effective implementation of quality management procedures ensures that the designed safety features are consistently reproduced during production. 

The second approach - creation of systems for non-destructive testing quality assurance in compliance with ISO standards 9000 series - considers the quality system as an assembly of organisational strueture, procedures, processes and resources necessary for overall quality management at the laboratory. This approach requires methodieal development. 

TQM involves all the organizations, all the functions, the external suppliers, the external customers and involves the quality policy. Similarly, TQM cannot be achieved without good Quality Management Systems (QMS) which bring together all functions relevant to the product, providing policies, procedures and documentation. The elements of a quality organization consist of these three mutually dependent items (Field and Swift, 1996) ... 

Quality management is both a technical subject and a behavioral subject. It is not a bureaucratic administrative technique. The rise in popularity of ISQ 9000 has created some unhelpful messages such as the document what you do strategy. There has also been a perception in the service industries that ISQ 9000 quality systems only deal with the procedural aspects of a service and not the professional aspects. For instance in a medical practice, the ISQ 9000 quality system is often used only for processing patients... 

Primarily, the designated person is the system designer for the quality system. This person may not produce the policies and procedures but operate as a system designer. He/she lays down the requirements needed to implement the corporate quality policy and verifies that they are being achieved. It is also necessary to have someone who can liaise with customers on quality issues, who can coordinate the assessment and subsequent surveillance visits, who can keep abreast of the state of the art in quality management. The person should be an adviser to the top management who can measure the overall performance of the company with respect to quality. 

The elements of the system can be construed to be the 20 elements of ISO 9001. The components of the system are different. ISO 8402 states that a quality system is the organizational structure, procedures, processes, and resources for implementing quality management. It therefore follows that in reviewing the quality system one needs to review each of these aspects. 

To keep your policies and procedures up-to-date with the latest industry practices you should provide a means of identifying new developments. This can be done by scanning journals, attending seminars and conferences, and generally maintaining an awareness of developments in quality management and technologies relevant to your business. 

The organization structure, procedures, processes, and resources needed to implement quality management (ISO 8402). 

PSM buiids on what is in piace, and seeks to integrate safety issues into ongoing business operations"as opposed to imposing an eiaborate exter-nai structure. The goais of PSM are process-oriented, not procedure-driven, and reflect the Total Quality Management principle of continuous improvement. 

The basic premise of the SLIM technique is that the probability of error associated with a task, subtask, task step, or individual error is a function of the PIFs in the situation. As indicated in Chapter 3, an extremely large number of PIFs could potentially impact on the likelihood of error. Normally the PIFs that are considered in SLIM analyses are the direct influences on error such as levels of training, quality of procedures, distraction level, degree of feedback from the task, level of motivation, etc. However, in principle, there is no reason why higher level influences such as management policies should not also be incorporated in SLIM analyses. 

A quality system comprises the organizational structure, responsibilities, procedures, processes, and resources used to implement quality management, or ESH/PSM management in this case. This part of the standard includes a somewhat detailed discussion of each of the parts of the quality system as well as its documentation. 

The primary purposes for which reference materials are employed are encompassed within the laboratory Quality Assurance Procedures. Quality assurance comprises a number of management responsibilities which focus on how the laboratory is organized, how it deals with situations, how it interacts with users, together with analytical responsibilities re internal quality control and external quality assessment (Sargent 1995 Burnett 1996). Ideally each component follows a documented protocol and written records of all activities are maintained. 

Reported data should achieve a clear, purpose-oriented level of accuracy and precision, especially when data produced by several laboratories often needs to be compared as part of a decision process. It has become accepted by more and more analysts that to overcome differences between national standards and specifications and measurement procedures or to make Total Quality Management (TQM) an achievable reality, freely available and internationally agreed points of reference are needed. Therefore RMs and CRMs must be easily available indeed the availability of reference materials has been described as an issue of strategic importance to the EU (Maier et al. 1997). 

List the work instructions and standard procedures used in your laboratory that you think contribute to your laboratory s quality management system and should therefore appear in a Quality Manual. 

A laboratory must have a defined quality management system, which is described in the Quality Manual. The procedures for auditing and reviewing... 

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