Policy Statement

Bubble Policy The bubble concept introduced under PSD provisions of the Clean Air Act Amendments of 1977 was formally proposed as EPA policy on Jan. 18, 1979, the final policy statement being issued on Dec. 11, 1979. The bubble pohcy allows a company to find the most efficient way to control a plant s emissions as a whole rather than by meeting individual point-source requirements. If it is found less expensive to tighten control of a pollutant at one point and relax controls at another, this woiild be possible as long as the total pollution from the plant woiild not exceed the sum of the current hmits on individual point sources of pollution in the plant. Properly apphed, this approach would promote greater economic efficiency and increased technological innovation. 

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. 

Policy Statement on Severe Accidents Regarding Future Designs and Existing Plants" (Federal Register, 50FR32138). 

The Severe Accident Policy Statement formulates systematic safety examinations for detection of accident vulnerabilities and implementation of cost-effective changes. The NRC issued Generic Letter 88-20 to implement this plan through IPEs. While the primary goal was the identification of plant vulnerabilities, no definition of vulnerability was provided. Only 4 operators of BWRs identified vulnerabilities and only 16 operators of PWRs did so. Over 500 plant improvements were identified, but few vulnerabilities were. 

These are addressed ind The Backfit Rule (10 CFR 50.109, and the NRC Safety Goal Policy Statement (SECY-89-102). The Backfit Rule applies not to the regulated industry, but to the NRC staff. It says that backfitting is required if it will result in substantial increase in safely and the direct and indirect costs of backfitting are justified. (This limitation does not apply if the modification is necessary for compliance with regulations). 

The Safety Goal Policy Statement was published to define acceptable radiological risk IVom nuclear power plant operation, and by implication provide a de minimus risk to be assured without cost considerations. Safety beyond the minimum requires cost-benefit analysis. Since being promulgated, bulletins and generic letters have been imposed to enhance safety, under the provisions of 10 CFR 50.109, the Backfit Rule. 

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). 

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... 

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 ... 

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. 

A common practice is to paraphrase the requirements of ISO/TS 16949 as operational policy statements. Whilst this approach does provide direct correlation with ISO/TS 16949 it does not by itself add any value since users can read the same things by referring to ISO/TS 16949. Operational policies should respond to the requirements, not paraphrase them, and they should provide solutions appropriate to the organization, as given in the following examples ... 

As you know from the policy statement distributed last month, we recognize continuous improvement in process safety management (PSM) as a company priority. 

In many industries, rule books have a tendency to become enshrined as policy statements, either for internal or external regulatory purposes. Unfortunately, the format that is appropriate for a regulatory or standards document is unlikely to fulfill the requirements of an effective operating instruction or procedure to provide assistance in carrying out a task effectively. 

In 1993, shortly after the FDA announced their first policy statement on enantiopure drugs, separations of pharmaceutical compounds were performed using SMB technology [25, 26]. Other applications now include fine chemistry, cosmetics, and perfume industry [27]. 

FDA s Policy Statement on the Development of New Stereoisomeric Drugs (Stereoisomeric Drug Policy) Fed. Regist. (1992) 57 FR22249. 

A more detailed document in the form of a health and safety manual. This manual would include the company s policy statement, company rules, safe working procedures, etc., and would normally be located in a nominated office. It is necessary in using this method that all staff are made aware of its contents and its location. 

The company s general policy statement should be a declaration of the employer s intent to provide a safe and healthy workplace for all employees and should include the request that the employees provide the necessary support towards achieving the company s aims. 

The policy statement should give the name, designation and office location of the nominated senior member of the company designated as the responsible person within the organization for ensuring that the company s policy... 

Where specialist knowledge is required, the relevant aspects should be clearly established and the respective persons made aware of such. This expertise can be obtained, for example, from the company s safety officer, chemist, etc. Finally, the policy statement should make clear the level of responsibility of every employee. 

In short, we return to C. P. Snow s recommendation that the scientist and humanist converse more. The conversations, analysis, and discussion should include the third culture, the technologist. Therefore, although we have not provided specihc and detailed analysis of issues related to computer use in the pharmaceutical industry, believing as we do that that sort of analysis is for the specialized philosopher doing conceptual analysis in computers ethics, we do urge that applied philosophers be part of the research team. Also, in the dynamic and flexible world of technology, applied philosophers—not just the people in the held of computers—should help draft policy statements and codes of conduct. 

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