Standard compliance assessment

Assessing clinical and quality requirements of the proposed program also means planning for how to comply with these standards. Compliance should be considered both on an initial basis and over the long term. Clinical and quality requirements may necessitate the hiring of certain (qualified) staff, the development of work processes to monitor quality, and the implementation of technology or procedures to ensure compliance. 

For a standard that is to be used within a formal compliance assessment regime, we must obviously define the limit value (the magnitude ) of the standard. However, the scientific analysis will also need to address four other criteria that are needed for a defensible standard. These are dealt with in detail in Chapter 3 in summary, these are as follows ... 

Reference conditions These are physical or chemical parameters that need to be assessed in conjunction with the analysis for standard compliance (e.g., temperature, pH, organic carbon content for soil or dissolved organic carbon, and total suspended solids for surface water) (depending on which factors influence chemical behavior and toxicity). 

Unless a standard is actually implemented, its development would remain a purely academic exercise. The final step in the proposed framework deals with implementation of standards. However, different types of standards have very different implementation requirements, ranging from comprehensive sampling and compliance assessment schemes within some sort of legal regime to the agreement of text for a warning label. 

Throughout, we have tried to identify where flexibility in a standard may legitimately be introduced. There are many different types of standard, and they all have a place in controlling chemical exposure in the environment. However, the type of standard to be used, and any measures to assess compliance with it, must be decided at an early stage. This is a policy decision. As well as the type of standard, flexibility can be introduced in the magnitude of the standard itself (it may be more or less protective) and, for standards that are subject to formal compliance assessment, in the way we decide whether the standard has been passed or failed. There is clearly more to a standard than merely the concentration, dose, or load of a substance. Aspects such as design risk, return period, and confidence of failure are integral features of the standard and, as such, should be subject to the same scrutiny. 

Absolute limits cannot be used in statistical assessments of compliance based on sampling such standards need to be translated into percentiles to be used. The reasons for this are that standards are usually set in a precautionary manner, and it is nearly always the case that occasional exceedances of a limit value are acceptable. With such an absolute limit, the risk of reporting failure is strongly influenced by sampling frequency the more sampling, the higher the likelihood that at least 1 sample will fail. This is an important consideration if compliance assessments are to be used to compare regions or nations in a way that has serious implications for poor performers. 

We argue in this chapter that an implementation analysis should inform the entire life cycle of a standard, from the original specification, through derivation, to its implementation, use, review, and eventual revision or withdrawal. It will also be helpful to anticipate future uses such as the use of compliance assessments to compare regions and nations (where these are not in place already). 

Siegel M. D., Chu M. S., and Pepping R. E. (1983) Compliance assessments of hypothetical geological nuclear waster isolation systems with the draft EPA standard. In Scientific... 

Fulfill company and legal requirements by conducting regular environmental audits and compliance assessments (including facilities and suppliers), and insure transparency by providing information to the Board and other stakeholders such as outside authorities, employees, and the public (Standards sources for this particular question ICC-BCSD, Calvert, Innovest, DJSI.)... 

It has already been stated that the purpose of QC, in its strictest interpretation, is to determine compliance of a component, a product or service, etc., with an agreed standard. This assessment will form the basis for the decision on acceptability. 

Below is a list of parameters (some are new, others are taken by present EU standards) previewed by the compliance assessment ... 

This emerging evidence of non-compliance is not generally evident in the recent synthesis report from the European Commission (2008) for the period 1999 to 2001, albeit four countries were identified where lead problems existed however, some countries did not submit their national report, some national reports were incomplete, the methods of sampling used for lead were not identified, and the bench-mark for compliance assessment was the earlier standard for lead of 50 pg/1 from Directive 80/778/EEC. 

The actual level of contractor coiq)1iance with the applicable requirements of the Order is unknown at this time. The USRC ESH QA - Related Order Compliance Plan (Reference 54) is incomplete however, a detailed compliance assessment is underway. Based on disclosures from the contractor and reviews by DOE, it is known that full compliance is lacking with six of the ANSI standards listed in Attachment 2 of the Order. Specifically ... 

The design of piping supports should be commensurate with the piping system standard. Stress assessment for piping and components should be conducted in compliance with applicable nuclear codes and standards. 

Quality in NDT depends upon a number of factors. Qualification of NDT personnel, technical state and correctness of choice of testing equipment, availability of approved working procedures of examination, calibration of NDT equipment have decisive importance among those factors of an NDT laboratory. Assessment of NDT laboratory competence is provided through accreditation in compliance with the EN 45000 series standards. 

Appendix B of the standard outlines a nonmandatory compliance section regarding hazard assessment and PPE selection. This Appendix outlines general guidelines for identifying, organizing, and analyzing sources of hazards and selection criteria for the appropriate PPE. 

A checklist analysis (CCPS, 1992) verifies the status of a system. It is versatile, easy and applicable at any life-cycle stage of a process. It is primarily used to show compliance with standards and practices by cost-effectively identifying hazards, chlorine Tar> <- liccklists provide commonality for management K.-, icw of hazard assessments. It may be used for controlling a proces.s from development to decommissioning. Approvals by appropriate authorities Cl i( V each stage of a project. 

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. 

Subcontractor development should not be limited to the assessment for compliance to ISO/TS 16949 as indicated in Note 1. The standard contains the minimum requirements and, with the requirement for continuous improvement, it may be necessary to work with some of your subcontractors in order to develop their capability to improve process capability and delivery schedules or reduce avoidable costs. You can t develop all your subcontractors and hence Note 2 of the standard indicates that you should prioritize subcontractors for development based upon performance and importance of product or service supplied. 

Procedures are required for the control and maintenance of inspection, measuring, and test equipment and to cover test software, not only for calibration. This section of the standard is often referred to as the calibration requirement but it goes far beyond mere calibration. In assessing compliance with section 4.11, there are at least 30 requirements to check (see the questionnaire at the end of this chapter) and calibration is only one of them. Figure 11.2 shows the processes needed to control, calibrate, and maintain inspection, measuring, and test equipment. The shaded boxes indicate interfaces with other processes. 

Management must institute procedures to assess levels of compliance with agreed standards for safety. Techniques include environmental and/or biological monitoring, health surveillance, safety audits, safety inspections, and procedures for accident reporting, investigation and analysis. Communication is essential, e.g. by provision of information (on specific chemicals, processes, etc.), safety meetings, notices, safety bulletins etc. 

ISO has two important functions in analytical chemistry. The first is to publish descriptions of accepted methods. These are effectively industry standard methods for particular protocols. The second is in laboratory accreditation. For a laboratory to be ISO accredited, compliance with international QA standards must be confirmed by an initial assessment and subsequently from repeated audits by an independent assessor. Since ISO has no legal or regulatory powers, the standards are voluntary. It is unlikely, however, that a forensic analysis which did not conform to an ISO standard would be upheld in court, for example. Most commercial laboratories need to be accredited to remain competitive and to deal with regulatory authorities. Most university labs are not accredited, mainly due to the time and costs involved, and also to the nonroutine nature of much university research. However, university accreditation may become a requirement in the near future, especially for publicly funded research in the UK. The details of laboratory accreditation are discussed by Christie et al. (1999) and Dobb (2004). 

Member States shall take all measures necessary to ensure that the laboratories referred to in Article 7 of Directive 89/397/EEC1 comply with the general criteria for the operation of testing laboratories laid down in European standard EN 450013 supplemented by Standard Operating Procedures and the random audit of their compliance by quality assurance personnel, in accordance with the OECD principles Nos. 2 and 7 of good laboratory practice as set out in Section II of Annex 2 of the Decision of the Council of the OECD of 12 Mar 1981 concerning the mutual acceptance of data in the assessment of chemicals.4... 

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