Objective quality evidence

Documentation (1) Design products (specifications, drawings, maintenance standards, system diagrams, etc.), and (2) objective quality evidence (defined later)... 

Certification is also strictly based on what the SUBSAFE program defines as Objective Quality Evidence (OQE). OQE is defined as any statement of fact, either quantitative or qualitative, pertaining to the quality of a product or service, based on observations, measurements, or tests that can be verified. Probabilistic risk assessment, which usually cannot be verified, is not used. 

The participatory audit philosophy and the requirement for objective quality evidence. 

The main objective of air quality guidelines and standards is the protection of human health. Since fme particulates (PM,) are more likely to cause adverse health effects than coarse particulates, guidelines and standards referring to fine particulate concentrations are preferred to those referring to TSP, which includes coarse particulate concentrations. Scientific studies provide ample evidence of the relationship between exposure to short-term and long-term ambient particulate concentrations and human mortality and morbidity effects. However, the dose-response mechanism is not yet fully understood. Furthermore, according to the WHO, there is no safe threshold level below which health damage does not occur. 

There are two requirements addressing records of the management review which when combined require firstly that records of management review be maintained and secondly that these records provide as a minimum evidence of the achievement of objectives specified in the quality policy and the business plan and evidence of customer satisfaction with product supplied. 

The supplementary requirements provide a welcome addition to this somewhat inadequately specified clause of ISO 9001. However the reference to clause 4.1.1.2 with respect to objectives specified in the quality policy is somewhat ambiguous. Clause 4.1.1.2 does not require objectives to be included in the policy this is required in clause 4.1.1.1. As stated previously, system effectiveness is judged by how well the system enables implementation of policy and achievement of objectives. Therefore, requiring records that contain evidence of this is a logical interpretation. Such records need to identify the matters reviewed, the results, the actions, and the decisions taken, together with the names of those responsible and the date by which actions are to be completed. The records should also contain the data used to conduct the review as the basis upon which the decisions have been made and so that comparisons can be made at later... 

While the plan itself is not auditable by third parties, it may be auditable by second parties i.e. customers. The third party or registrar is entitled to examine the plan to ascertain that it is what it proclaims to be. The particulars are of no concern except those aspects relating to quality, such as the resources, quality objectives, customer satisfaction plans, and performance metrics. Whatever is stated on these aspects, the auditors will expect to see evidence that the business plan is not merely a wish list and that provisions have been made to enable implementation through the quality system. 

Measuring employee understanding of appropriate quality objectives is again a subjective process. Through the data analysis carried out to meet the requirements of clause 4.1.5 and 4.2.8 you will have produced metrics that indicate whether your quality objectives are being achieved. If they are being achieved you could either assume your employees understand the quality objectives or you could conclude that it doesn t matter. However, it does matter as the standard requires a measurement. Results alone are insufficient evidence. The results may have been achieved by pure chance and in six months time your performance may have declined significantly. The only way to test... 

What evidence demonstrates that your quality system is suitable and effective in satisfying ISO/TS 16949 and your stated quality policy and objectives ... 

While procedures should define the quality records that are to be produced, these are the records that will be produced if these procedures are used. On particular contracts only those procedures that are relevant will be applied and therefore the records to be produced will vary from contract to contract. Special conditions in the contract may make it necessary for additional quality records. Records represent the objective evidence with which you are going to demonstrate compliance with the contractual requirements. It would therefore be expedient, although not essential, to list all the records that will be produced and where they will be located. The list does not need to detail every specific record, providing it identifies types of records and all new records to be produced. 

Some auditors believe that any document generated or used by the quality system is a quality record and will attempt to apply the requirements of clause 4.16. Whilst it can be argued that any documented output is a record of an activity, the reader is referred to ISO 8402 for a definition of records in the context of the quality system. ISO 8402 states that a record is a document which furnishes objective evidence of activities performed or results achieved. A quality record provides objective evidence of the fulfillment of the requirements for quality (e.g. product quality record) or the effectiveness of the operation of a quality system element (e.g. quality system record). 

Objective evidence of the achieved features and characteristics of a product or service and the processes applied to its development, design, production, installation, maintenance, and disposal as well as records of assessments, audits, and other examinations of an organization to determine its capability to achieve given quality requirements. 

Before starting treatment for RA, assess the subjective and objective evidence of disease. For joint findings, this includes the number of tender and swollen joints, pain, limitations on use, duration of morning stiffness, and presence of joint erosions. Systemic findings may include fatigue and the presence of extraarticular manifestations. Obtain laboratory measurements of CRP and ESR. The impact of the disease on quality of life and functional status is also important. 

Method validation is defined in the international standard, ISO/IEC 17025 as, the confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled. This means that a validated method, if used correctly, will produce results that will be suitable for the person making decisions based on them. This requires a detailed understanding of why the results are required and the quality of the result needed, i.e. its uncertainty. This is what determines the values that have to be achieved for the performance parameters. Method validation is a planned set of experiments to determine these values. The method performance parameters that are typically studied during method validation are selectivity, precision, bias, linearity working range, limit of detection, limit of quantitation, calibration and ruggedness. The validation process is illustrated in Figure 4.2. 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

Quality System shall provide for control of material and product identification during all stages of production and delivery. Identification is based on applicable drawings, specifications, or other documents. When required or specified, complete traceability of material or product shall be maintained by issuing unique or batch control numbers and/or markings. The identification and trace-ability procedure shall be fully documented to provide objective evidence of compliance with this Code in accordance with this requirement. 

Apart from the need to avoid such adverse effects on the people involved in the investigation of an explosion, there is also a need to be aware of possible risks to the quality of the actual work. Good scientific work requires the maintenance of an impartial objective and open-minded attitude to the collection and evaluation of evidence. Moreover, the more horrific the crime, the more important it is to establish the tmth... 

The laboratory should ensure the establishment of an effective and efficient internal audit process to assess the strengths and weaknesses of the quality management system. The internal audit process provides an independent tool for obtaining objective evidence that the existing requirements have been met, since the internal audit evaluates the effectiveness and efficiency of the laboratory. 

Measirement analysis and improvement The process approach Documented quality management system Objective evidence of the conformance of the laboratory activities to the requirements... 

Ginseng has been popular for more than 2000 years as a tonic for improved stamina and sense of well-being, particularly in the elderly. Although subjective quality of life reports substantiate this tradition, objective evidence of improved cognitive function and physical stamina remains incomplete or lacking. Further studies of standardized ginseng preparations will be necessary to clarify its use in fatigue and diabetes. 

Software validation is not separately defined in the quality system regulation. The FDA considers software validation to be the confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled [14]. Software validations have special concerns on software installation, implementation, and utilization. A software validation consists in several tests, inspections, and verifications performed to assure the adequate installation and use of software and that the tasks performed meet all the specifications defined. Software validations must be performed under the environmental conditions to which software will be submitted. This is particularly important in medical devices that are used under special conditions, such as close to or inside the human body. 

In a farsighted move in 1989, the European Union laboratory IRMM started a series of interlaboratory comparisons to provide objective evidence for the degree of equivalence and the quality of chemical measurements by comparing a participant s measurement results with external certified reference values (IRMM 2006). At the time most proficiency testing schemes used consensus results for the mean and standard deviation to derive z scores. With the IMEP-1 analysis of lithium in serum, the world was alerted to the problem of lack of accuracy in analytical measurements. The data of the first IMEP-1 trial are replotted in figure 5.6 notice that the apparent outlier was the only laboratory to come close to the assigned value. 

Method validation is a term used for the suite of procedures to which an analytical method is subjected to provide objective evidence that the method, if used in the manner specified, will produce results that conform to the statement of the method validation parameters. Like many aspects quality assurance, method validation is of a relative nature. As with the concept of fitness for purpose, a method is validated for a particular use under particular circumstances. If those circumstances vary, then the method would need to be re-validated at least for the differences. Common sense should be used, and the analysts should use his or her skill and experience to decide what aspects of a method require validation and to what extent. The goal of satisfying client requirements is prominent in most published definitions of method validation, some of which are listed below ... 

The international standard ISO 9003 1994 was established by Technical Committee ISO/TC 178, and is based on British standard 5750 1987 series, European standard EN 29000 1987 series, and international standards ISO 9000 1987 series. The standard was adopted by the company to provide objective evidence that the company s operations of final product inspection and testing are in compliance with the requirement of this standard. However, this third edition canceled and replaced the second edition (ISO 9003 1994). The quality manual QM-4 is revised in accordance with the corresponding changes specified in the third edition of ISO 9001 2000 to specify quality system requirements for use where a contract between the company and customer requires the demonstration of capability of final product inspection and testing with customer satisfaction. The permissible exclusions are made to ... 

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