Certification test protocols

Snhseqnent chapters cover installation considerations (Chapter 6), inspection and maintenance practices (Chapter 7), regnlations, standards, and codes, inclnding certification test protocols (Chapter 8), and some illnstrative examples (Chapter 9). Chapter 10 provides a snmmary of the present state-of-the-art and what other information and research is needed, followed hy appendixes, a glossary, and snggested additional reading. 

The quality documentation of the subcontractors emanates from the quality assurance plans (see section 4.3, Component procurement ). Furthermore test certificates, test protocols etc. of the quality-related activities carried out on the building site during the assembly and start-up, such as weld inspections, acceptance of the Technical Control Board etc., have to be enclosed. 

Having chosen the analytical instrument or system, Installation Qualification, IQ, should be carried out to ensure that the equipment works the way the vendor or manufacturer specifies it should. IQ should be performed in accordance with a written test protocol with acceptance criteria with certification from the installation engineer, who is suitably qualified. Full written records of all testing carried out should be maintained as well as ensuring that adequate documentation and manuals have been supplied. The latter should include any Health Safety information from vendor or manufacturer. 

Test or Certification Protocols and/or Product Standards are similar to standard test methods but include additional criteria (requirements). Typical test protocols or product standards specify which emission test method should be used, when it should be carried out (for example 3 days, 12 days or 28 days after the sample has been placed in the test apparatus), a list of target compounds (i.e., which compounds or groups of compounds are to be measured) and pass/fail criteria (i.e., limit levels for emissions above which a product would fail the certification process because one or more compounds are being emitted from that product material at an unacceptably high rate.)... 

Certificate is a testimony making reference to a test protocol that a drug, accessory substance, means of medical or packaging technology has been tested and found to be satisfactory. 

Consequently, various subsystems will also be needed to support the development of these more sensitive instruments. Systems for reliable sample collection, sample processing, and presentation of chemicals to sensors are essential. Standardized methodologies are needed. Systematic quality assurance of sensor evaluations can only be achieved through standard methodologies that have proved successful. Toward this end, the National Institute of Standard Technologies (NIST) is in the process of generating the standard testing protocol under which all future detection devices shall be tested for certification. 

VS4W was started as a 2-year certification study but was subsequently converted to a 10-year VSl study in 2002. A set of readings was taken in 2003, 2005, and 2010, at which time the program was extended to 2015. There are currently 1,524 solid samples and 273 variegated samples on exposure in Florida, Arizona, and Ohio. This group of samples was used as the baseline for the development of an accelerated test protocol that will be discussed later in this chapter. 

A validation test certificate, at least according to the system-suitability protocol, should be supplied when an instrument is sold. 

Facility personnel who perform testing and maintenance on fire protection equipment and systems must be trained, experienced, and knowledgeable in the systems and the protocols for testing and maintenance. Knowledge can include work history, educational experience, craft certification, manufacturer certification, field verification, and job assessment and testing. Facility person-... 

Cleaning and disinfection documents, disinfection protocols, independent Legionella test results, conforming certificates. 

To satisfactorily meet and address these regulatory and market needs, standard methods for emissions testing need to be both robust and repeatable for competent laboratories to carry out, and practical and affordable for manufacturing industry. Uniformity of test methods, between countries and markets is also important if manufacturers are to avoid having to submit the same products for emissions testing by multiple different emissions certification protocols. 

Regulations, Standard Methods and Test/Certification Protocols 131... 

Before reviewing the range of standard methods and protocols that are already published or that are in the later stages of development, it is important to understand the fundamental differences and relationship between legislation or regulations, analytical test methods and certification protocols and product standards ... 

Improvement schemes can be defined as a succession of individual interlaboratory studies in which several laboratories analyse the same test samples for the same characteristics (usually the content of an analyte), following a similar protocol to validate each individual step of their own analytical method (Quevauviller, 1999a). They enable laboratories to develop and validate all steps of new or existing analytical procedure(s) in adequately organised successive exercises which may be considered as preliminary studies for laboratory or method performance studies or certification of RMs (Griepink and Stoeppler, 1992 Quevauviller, 1998b). Such programmes are particularly valuable in the case of speciation studies since the analytical procedures include several complex and critical steps. 

Present-day analytical laboratories are increasingly under pressure to supply objective evidence of their technical competence, of the reliability of their results and performance, and to seek formal certification or accreditation. This pressure may come from the laboratory s customers (e.g., industry and national bodies) but may also be due to scientific considerations. A QM system in place, validation of methods, uncertainty evaluation, the use of primary standards and CRMs, participation in ILCs, and PT, all serve to assure and demonstrate the quality of measurements. Compared to, say, 30 years ago, the stability of the equipment now available is much improved, and a greater range of RMs for method validation and calibration is accessible. Nevertheless, to achieve mutual (international) acceptance of various bodies of evidence for QA activities, a number of protocols have been developed. The most widely recognized protocols used in chemical measurements and testing are the ISO Guide 9000 2000, ISO/IEC 17025 2005, and OECD Guidelines for GLP, as well as its national and sector equivalents. 

List the names, addresses, and telephone numbers for all test laboratories involved in the study. An investigator must be able to contact laboratory personnel at all times. The protocol must include a record of where laboratory testing is being conducted. The laboratory director s CV and the laboratory s certification number have to be kept on file. 

Following completion of all testing and certification of the facility, documentation should be developed and retained, which may be used as proof of performance in accordance with the protocol in the as-built configuration Periodic retesting and monitoring at specified intervals in the at-rest and operational modes should be carried out to maintain operation of the facility in accordance with SOPs or industry standards. 

In the following, the synthesis of the most often employed stationary phase is discussed spherical silica with an n-octadecyl modification. The synthesis route has been chosen because all synthesis steps are well characterized and documented in standard operation procedure (SOP) protocols. The objective of this work was to develop a manufacturing process for a reversed phase C18-bonded silica column for HPLC according to standardized and validated procedures and to perform certification of the column, the tests and the mobile phases (du Fresne von Hohenesche et al., 2004). Figure 3.13 shows a scheme of the whole manufacturing process, and Table 3.7 summarizes the main steps. 

Hardware validation data and protocols should be kept by the company. When validation information is produced by an outside firm, e.g. computer vendor, the records maintained by the company need not include all of the voluminous test data however, such records should be sufficiently complete (including general results and protocols) to allow the company to assess the adequacy of the validation. A mere certification of suitability from the vendor, for example, will be inadequate. 

In principle, the certification of RMs for microbiological parameters does not differ from the approach used by BCR for chemical parameters. They fall into the category of method-dependent CRMs certified for an activity. In fact, the microbes will behave differently from one type of method (in particular the culture medium) to another. For selective media the resuscitation rate of the microbes in the RM will change. Injured bacteria will have difficulties to form colonies on these media. This reflects the biological activity of the strain after stabilisation. As the method will strongly affect the result, it must be verified that the method was applied in a similar way by all participants. This means that accurate protocols have been prepared and tested beforehand in a feasibility study. The first step of the evaluation of the certification study will be to verify that the protocol was strictly followed. This protocol will be made available to the users of the CRM. 

An example may be found in the determination of pesticides in a milk powder laboratories monitoring the quality of milk products usually express the data on the basis of the fat content for a proficiency test, the protocol describing the task for the determination of organochlorine pesticides (OCP) in milk powder should also request the determination of the fat content. On the other hand, the protocol for the certification of OCP in milk powder may only focus on results expressed on the basis of the total milk. 

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