Quality statement

Water quality statement from local authorities certifying compliance with effluent waste regulations... 

As mentioned above the quality policy is one of the most important parts of the quality manual. The whole system should only reflect and realize the quality statements and requirements in the daily work. The policy shall be authorized by the top management, because this statement has to reflect clearly, how cracial quality aspects are in the work of the laboratory. 

It should be recognized that most pharmaceutical companies develop quality statements as part of their business rationale. This declaration often includes much, if not all, of the following precept [5] It is the policy of the company to provide products and services of a quality that meets the initial and continuing needs as well as the expectations of the customer in relation to the price paid and to the nature of competitive offerings, and in so doing, to be the leader in product quality reputation. 

New York City. 1998 Drinking Water Supply and Quality Statement. Data Tables. 

In Sects. 2.2.1-2.2.3, we will review the basics of three particular CG models that will feature in the remainder of this paper. The choice of models is not meant to imply a quality statement but merely reflects our own experience and work. 

Based on the discussed advantages, it is also relatively easy for the users of AA to include the concept of traceability in the quality statements on results from the users laboratory. Traceability is defined in the international vocabulary on metrology (VIM 2007) as The property of a result of a measurement or standard whereby it can be related to a stated reference, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties. AA procedures have generally little problem to demonstrate the unbroken chain of comparison (see Eq. (30.35)) and can provide a complete uncertainty budget (see O Sect. 30.6.2). 

The RELMA method is a laser induced emission spectral analysis, which is applicable as an instrament for quality assurance in the rubber mixing room. With the RELMA technique, relative element concentrations and their distribution can be determined in a macroscopic scale in usual cycle times of internal mixers. Therefore, quality statements about the compound or even end products can be drawn very fast. Within this paper the optimised RELMA method will be presented and some examples for the application will be shown. In the second part of the application, the RELMA method as a quality assurance instrament for liquids (plasticisers) and disperse solids (carbon black) will be described. 11 refs. 

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. 

Invoices statement of procedure for submitting invoices Quality Control explanation of responsibilities for analysis of supplied materials, finished product, and work in progress consequences of off-spec materials procedure for rework Process Ownership specification of who owns the process, degree of liability for remediation, procedure for review and approval of process changes... 

This policy statement may be combined with that of safety (quality and safety should be twin objectives) and should be signed or properly reviewed within the last 12 months. 

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. 

Chapter 1 of this book starts with a detailed statement of the problem, as outlined above, focusing on the opportunities that exist in product design in order to reduce failure costs. This is followed by a review of the costs of quality in manufacturing... 

Stationary monitoring networks are also operated to determine the impact of new sources of emissions. As part of the environmental impact statement and Prevention of Significant Deterioration processes, the projected impact of a new source on existing air quality must be assessed. Air quality monitoring is one means of making this type of assessment. A monitoring network... 

The Design Protocol must contain three different data sources which, for convenience, will be termed the Design Data Bases. The first data base will contain the exigencies of the analyst and will be given the title Performance Criteria. The performance criteria must contain explicit statements, given, wherever possible, in numerical terms that define the quality of the separation that is required in order to achieve an accurate analysis. 

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. 

You will note that the heading of this section of the standard is Quality policy, and not Quality policies, as if there should be only one policy. Many companies do have a single quality policy statement at the front of their quality manual, but this is more of a quality philosophy rather than a policy of a form that will guide conduct (see also Commitment). 

Any statement made by management at any level which is designed to constrain the actions and decisions of those it affects is a policy. ISO 9001 could therefore be requiring policy on quality at all levels to be defined. It is only by consulting ISO 8402 1994 that the level of policy required is clarified. 

In the context of ISO 9001, the quality policy referred to in clause 4.1.1 is one of the corporate policies. It is characterized by a single policy statement which declares the organization s commitment to quality and the strategy adopted to discharge this commitment. 

The following are some typical quality policy statements ... 

Some quality policy statements are as simple as these, others are much longer (see below) but all seem to be accommodated by a single page. Very short statements tend to become slogans which people chant but they rarely understand their impact on what they do. Their virtue is that they rarely become outdated. Long statements confuse people because they contain too much for them to remember. Their virtue is that they not only define what the company stands for but how it will keep its promises. 

While these and many other contemporary quality policies would not need to be publicized 20 or so years ago, policy statements are not something new to the automobile industry. The General Motors of the 1920s under the direction of Alfred P Sloan used corporate policy as a means of coordinating the efforts of several divisions. GM s quality policy was to build quality products sold at fair prices and in setting up an Executive Gommittee Sloan wrote on the subject of quality, A carefully designed policy should be... 

There is no guidance in ISO 9000 1994 on the subject matter of corporate quality policies. However, in the Committee Drafts (CD) of ISO 9000 2000 there is now some useful information. It is recommended that the quality policy should be consistent with the overall policy and goals of the organization and should provide a framework for the setting of quality objectives and quality targets. For the first time in these standards, a link has been made between policy and objectives so that policies are not merely motherhood statements but intentions for action. By deriving objectives from the policy you initiate a process for bringing about compliance with policy. 

If we were to build policy statements from these principles we would find that an organization s quality policy would ... 

Commitment can be defined and documented either through the quality policy statement or through a Vision and Values Statement that defines management values with respect to ... 

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. 

Whether you address all five of these subjects for quality objectives depends on your strategy but all need to be defined in the business plan and all need to deploy the quality policy, thereby making a standalone statement of objectives unnecessary. 

The subject matter of quality objectives is prescribed by the quality policy to some extent. Hence an appropriate method would be to derive one or more statements of objectives from each statement in the quality policy. If you adopt the eight quality management principles as your framework, having eight groups of quality objectives would not be unreasonable (see previously under Subject matter for quality policy). 

The first two statements in clause 4.1.1.4 create an ambiguity when read together. The first calls for improvements in quality, service, cost, and technology (but not productivity) to be provided for in the quality policy but not implemented and the second calls for improvement in quality and productivity to be identified and implemented with no mention of cost, service, or technology. 

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 order to verify that the products or services meet the specified requirements you will need to carry out tests, inspections, assessments, etc. and these need to be performed against unambiguous standards of acceptability. You need to establish for each requirement that there are adequate criteria forjudging compliance. You need to establish how reliable is reliable , how safe is safe , how clean is clean , how good is good quality . Specifications often contain subjective statements such as good commercial quality, smooth finish, etc., and require further clarification in order that an acceptable standard can be attained. The secret is to read the statement then ask yourself if you can verify it. If not, select a standard that is attainable, unambiguous, and acceptable to both customer and supplier. 

A statement of work which you require the subcontractor to perform - it might be design, development, management, or verification work and will include a list of required deliverables such as project plans, quality plans, production plans, drawings, test data, etc. You need to be clear as to the interfaces both organizationally and technically (see Part 2 Chapter 4). 

Within your procedures you need to provide a means of identifying which items have been subject to inspection at the subcontractor s premises and the receipt inspection action to be taken depending on the level of that inspection. In one case, the product may have been accepted by your representative on the subcontractor s premises. In another case, a product from the same batch may have been accepted by your representative but not the one that has been delivered. Alternatively your representative may have only performed a quality audit to gain a level of confidence. You need to specify the inspection to be carried out in all such cases. The standard emphasizes that consideration should also be given to the recorded evidence provided. Even if someone has performed inspection at the subcontractor s premises, if there is no evidence of conformance the inspections are of little value. The fact that an inspection was carried out is insufficient. There has to be a statement of what was checked and what results were obtained and a decision as to whether conformance has been achieved. Without such evidence you may need to repeat some of the inspections carried out on the subcontractor s premises. 

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