Statements, quality systems

From this table one can see that all the additional requirements in ISO/TS 16949 were sourced from one or more of the four national quality system requirement documents. The location and wording of the requirements changed on incorporation into ISO/TS 16949. Many requirements from QS-9000 have been incorporated verbatim, whereas extracts from VDA, AVSQ, and EAQF were reworded so as to phrase the statements as requirements. 

A signed statement by management without its approval to the quality system documented policies and procedures will indicate that it is not committed to honoring the policies and procedures. Managers need to approve the documents within the quality system that prescribe activities for which they themselves are responsible. This serves to demonstrate that they agree with the manner in which the policy has been interpreted and are prepared to provide the resources needed to implement the documented practices. 

The 1987 version of ISO 9001 required the quality policy and the quality system procedures and instructions to be documented, clearly identifying three levels of documents in practice, organizations produced an intermediate level between the quality policy statement and the procedures which addressed the requirements of the standard and cross-referenced the associated procedures. This intermediate level together with the quality policy statement was often referred to as the quality manual. However, some manuals merely paraphrased the requirements of the standard, some described the quality system, and others confined the manual to the organization s operational policies. The guidance given in clause 5.3.1 of ISO 9004-1 suggests that the quality system documentation consists of policies and procedures. Clearly these policies are of a somewhat lower level than the corporate quality policy addressed in Part 2 Chapter 1. 

In the quahty manual the laboratory s management system policies and objectives shall be defined. The quality policy statement shall be issued imder the authority of the top management. For more details on quality manuals see chapter 7. 

Clause 4.2.2 of ISO/IEC 17025 requires that a quality policy statement be issued by the top management and that the quality system policy and objectives are defined and documented in the quality manual. 

The laboratory s management system policies related to quality, including a quality policy statement, shall be detned in a quality manual (however named). 

A consensus vision statement was drafted at the July 2003 ICH meeting with regard to the objective of the ICH in harmonizing the efforts of regulatory bodies to establish quahty systems approaches in their operations Develop a harmonized pharmaceutical quality system applicable across the life cycle of the product emphasizing an integrated approach to quality risk management and science. ... 

Senior management (e.g., the CEO, president, business group responsible head) should establish a compliance plan that defines the quality standards and practices, resources, and activities relevant to its operations. A core element and guiding principle should be the quality policy or mission statement. This policy or mission statement should reflect senior management s quality objectives for the company. It represents the foundation upon which all other quality systems are built. 

The manufacturing department ships the product in accordance with manufacturing guidelines, based on the receipt of valid purchase orders. The product documentation includes a Declaration of System Validation with statements from Hewlett-Packard that the software was developed and tested according to the Hewlett-Packard Analytical Software Life Cycle, a process that has been certified for ISO 9001 quality standard and for the information technology quality system (ITQS) compliance and that has been inspected by representatives from both computer validation companies and the pharmaceutical industry. 

Analytical results for the determination of antibiotic residues in food, in common with results generated in other laboratories or branches of analytical chemistry, must be reliable and comparable. It is a requirement for laboratories accredited under the ISO/IEC 17025 quality system that the measurement uncertainty associated with a result should be made available and reported if it is required by the client, is relevant to the validity of the test results, or may affect compliance with a specification, for example, compliance with a maximum residue limit (MRL) for antibiotics. The Codex Alimentarius Commission also recommends that laboratories provide their customers on request with information on the measurement uncertainty or a statement of confidence associated with quantitative results for veterinary drug residues. The relevant sections in ISO 17025 are quoted below ... 

The way in which Root Cause Analysis (RCA) and a Corrective and preventive action system (CAPA) can be used to improve quality is given by the statement from GMP Chap. 1 Pharmaceutical quality system ... 

Quality control encompasses all activities used to bring a system into statistical control. The most important facet of quality control is written documentation, including statements of good laboratory practices, good measurement practices, standard operating procedures, and protocols for a specific purpose. 

There are a variety of ways to express absolute QRA results. Absolute frequency results are estimates of the statistical likelihood of an accident occurring. Table 3 contains examples of typical statements of absolute frequency estimates. These estimates for complex system failures are usually synthesized using basic equipment failure and operator error data. Depending upon the availability, specificity, and quality of failure data, the estimates may have considerable statistical uncertainty (e.g., factors of 10 or more because of uncertainties in the input data alone). When reporting single-point estimates or best estimates of the expected frequency of rare events (i.e., events not expected to occur within the operating life of a plant), analysts sometimes provide a measure of the sensitivity of the results arising from data uncertainties. 

An early application of fuzzy logic was in the control of a cement kiln and applications to similar or identical systems have continued to appear (see, for example, Jarvensivu et al.1). This is an example of a practical application in which generation of high quality product may depend on the skill and experience of a small number of workers. Even when computer control is available, workers may describe the way that they adjust conditions to provide a high-quality product by statements such as, "The kiln rotation rate should be lowered slightly," and that, in order to compensate, "The temperature should be diminished just a bit." Fuzzy logic now has a lengthening track record of use in such situations. 

Primary methods have the highest metrological qualities, whose operation can be completely described and understood, and for which a complete uncertainty statement can be written down in terms of SI units. Such methods are used by national laboratories participating in the development of a national or international chemical measurement system. 

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