Quality system maintenance

A system of planned maintenance may be introduced progressively, commencing with limited maintenance routines only on key items of plant and equipment. This may then be extended to a wider range of plant, utilising more complex routines, until such time as a 100% planned maintenance system has been implemented. As with quality systems, maintenance records and histories are essential to ensure smooth operation. 

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. 

Although there are only two basic requirements in ISO/TS 16949 for the establishment and maintenance of a quality system, they are perhaps the most important requirements of all. The quality system is a tool to enable you to achieve, sustain, and improve quality. It implements your quality policy and enables you to achieve your quality objectives either for control or for improvement. Quality systems, like any other system, need to be managed and so quality system management is a function of the business. This function consists of four principal processes ... 

As stated in Part 2 Chapter 1, maintenance is concerned with retaining something in or restoring something to a state in which it can perform its required function. Quality systems comprise the organization, resources, and processes as well as the documentation needed for achieving quality, so you need to maintain more than the documentation. 

Failure investigation procedure Nonconforming material review procedure Customer complaints procedure Quality system document change procedure Specification change procedure Maintenance procedures... 

Requirements pertaining to the design, development, implementation, and maintenance of quality systems. 

Quality systems require that facilities and equipment should be appropriate to the activities undertaken. Surfaces that are easy to clean and maintain in hygienic condition are a requirement in many situations. For example, cloth-backed chairs would not be acceptable in a laboratory that handled potentially biohazardous materials. Equipment should be checked at installation to demonstrate that it can perform its desired function. This is frequently done using an Installation Qualification, Operational Qualification and Performance Qualification (IQ /OQ/PQ) commissioning process. Routine maintenance and calibration programmes are then required to ensure that equipment continues to deliver the specified performance. 

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] ... 

System Evaluation and Supplier Assessment Usually there are many choices and suppliers for common COTS laboratory instruments. The user requirements and the operational requirements will provide the basic criteria for the selection. Obviously the chosen instrument must be able to fulfill the key requirements for its intended use. Other factors concerning the instrument such as its ease of use, maintenance, and reputation of the suppliers in terms of quality, reliability, and support should be considered. From a practical point of view, a supplier audit may not be viable or necessary for commonly used COTS instruments. A supplier assessment is sometimes used to evaluate whether the supplier has a good-quality system in place to support the development and manufacturing of the instrument of interest. The need for a supplier assessment depends on the criticality and complexity of the system to be obtained. 

During an on-line clean, the quality of the clean will normally be enhanced by the use of an initial chlorine dosing procedure at a pH of 7.2 to 7.6. This practice is to be recommended, irrespective of whether the current cooling system maintenance biocide program employs chlorine. With severely fouled cooling systems, it may be necessary to provide many hundreds of ppm of HOC1 in order to satisfy the oxidation demand. This in turn may require the use of a temporary, supplementary corrosion inhibitor, and almost certainly the use of some antifoam. 

A fundamental objective of a computer system applied to automate a pharmaceutical GMP operation is to ensure the quality attributes of the drug product are upheld throughout the manufacturing process. It is therefore important that quality-critical parameters are determined and approved early in the validation life cycle. The exercise should be undertaken to a written procedure with base information from the master product/production record file examined and quality-critical parameter values and limits documented and approved for the process and its operation. In addition, the process and instrument diagrams (P IDs) should be reviewed to confirm the measurement and control components that have a direct impact on the quality-critical parameters and data. This exercise should be carried out by an assessment team made up of user representatives with detailed knowledge of both the computer system application and process, and with responsibility for product quality, system operational use, maintenance, and project implementation. This exercise may be conducted as part of an initial hazard and operability study (HAZOP) and needs to confirm the quality-related critical parameters for use in (or referenced by) the computer control system URS. 

The cost of total system maintenance and enhancement is currently shared by over one hundred laboratories, reducing the cost and raising to overall system quality as compared to in-house efforts. Proven time and time again by software life cycle, this package is highly superior to any custom written system for long term support and lower acquisition cost. 

In addition to descriptions of procedures to be followed, the quality system must provide for the creation and maintenance of records which show what has been done. This is necessary to enable the laboratory to replicate, if required, the analytical process that was performed for a particular sample. The process of audit is only possible if adequate records are maintained and the absence of adequate records will constitute a non-compliance with most quality management standards (see Section 5.2). 

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. 

All quality systems need to demonstrate that the equipment used is properly maintained and in some instanees ealibrated. Computers are no exception to this. Therefore, records of the maintenance of the CDS need to be set up and updated in line with the work carried out on it. The main emphasis of the maintenance records is toward the physical components of a system hardware, networking, and peripherals. The software maintenance is covered imder the error logging system described above. 

To provide plant management with a forum to exercise their responsibility for the establishment and maintenance of an adequate and effective quality system. 

The main similarities of GLP and other laboratory quality systems may be seen in their focus on apparatus and instrument suitability, maintenance and calibration, where the requirements of accreditation systems go beyond what GLP is regulating, since these issues are of the utmost importance for generating accurate, precise and reproducible results. Thus, it has to be possible in every case to trace back the calibrations to the respective national standards of measurement, and the quality control of the measurements has to ensure that trends to deviations form the precision required are detected already early on. 

In practice, what does this imply Without going into detail, it must be stated that such a way of working is only possible if the laboratory has foreseen — a priori action — that repetition of the task can be undertaken and that this is the way customers should be handled. Quality work can only be produced in an organised system a quality system. It involves all aspects of the laboratory that affect the production of results people (analysts, managers, administrators), infrastructure (buildings, equipment), supply (chemicals, reference materials etc.) and control of third parties (maintenance companies, security auditors etc.). Everything must be up to date goods and people. 

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