Objective evidence

The assessor should look for objective evidence that subcontractors are made aware of and comply with the tollers safety standards and procedures. 

Conformance with ISO/TS 16949 for third party certification shall be based on objective evidence of meeting each applicable requirement including customer-specific requirements at the time of the audit. The auditor needs to determine specific customer requirements that apply and verify compliance with each requirement - not a sample. If the supplier has several different customers then compliance with the requirements of each customer has to be demonstrated. 

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. 

The standard allows for undocumented verbal orders but requires that the order requirements are agreed before their acceptance. The third party auditor cannot confirm conformity with this requirement as there will be no objective evidence to substantiate the transaction other than the payment invoice. If the supplier confirms the agreement in writing a written statement of requirement exists. The standard does not stipulate that the agreement has to be documented only that the requirements need to be documented regardless of who produced them. The only evidence that the requirements were adequately defined is therefore the payment from the customer against the supplier s invoice. 

The results of the design review should be documented in a report rather than minutes of a meeting, as it represents objective evidence that may be required later to determine product compliance with requirements, investigate design problems, and compare similar designs. The report should have the agreement of the full review team and should include ... 

Test reviews to be performed following qualification tests to confirm that sufficient objective evidence has been obtained to demonstrate that the product fulfills the requirements of the test specification... 

On the due date when the tenders should have been received, record those that have been submitted and discard any submitted after the deadline. Conduct an evaluation to determine the winner - the subcontractor that can meet all your requirements (including confidence) for the lowest price. The evaluation phase should involve all your staff that were involved with the specification of requirements. You need to develop scoring criteria so that the result is based on objective evidence of compliance. 

Sight of the objective evidence which purports to demonstrate that the particular product meets the requirement... 

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). 

To prove by reasoning, objective evidence, experiment, or practical application. 

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. 

Validation is an activity that can be defined as providing confirmation by examination and objective evidence that the particular requirements fior a specific intended use can he consistently Julfilled. 

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. 

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report ... 

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. 

When no validation data are available, then all of the relevant parameters will have to be studied. The degree of rigour with which the study is carried out will depend on issues such as criticality of the measurement and the availability of validation data on similar methods. There will be cases in the laboratory where a method has been used, satisfactorily, for a long period of time but there is no documentation to demonstrate the performance of the method. It seems unreasonable to require full revalidation when a method has been used successfully for some years. However, the need for objective evidence prevents the validity of such a method being taken for granted. A possible approach is to follow the plan below ... 

Method validation is carried out to provide objective evidence that a method is suitable for a given application. A formal assessment of the validation information against the measurement requirements specification and other important method performance parameters is therefore required. Although validation is described as a sequential process, in reality it can involve more than one iteration to optimize some performance parameters, e.g. if a performance parameter is outside the required limits, method improvement followed by revalidation is needed. 

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... 

Validation Confirmation by examination and provision of objective evidence that the particular requirements for a specified intended use are fulfilled. 

These clinical observations demonstrate that the effect of tamoxifen and other SERMs on the endometrium needs to be studied in depth in order to offer objective evidence-based information on these compounds to our patients. This chapter provides a summary of the information available on the mechanism of action and on the clinical data of SERMs on the endometrium. 

The competitive civil-service system is designed to give candidates fair and equal treatment and to ensure that federal applicants are hired based on objective criteria. Hiring has to be based solely on a candidate s knowledge, skills, and abilities (which you ll sometimes see abbreviated as ksa), and not on external factors such as race, religion, sex, and so on. Whereas employers in the private sector can hire employees for subjective reasons, federal employers must be able to justify their decision with objective evidence that the candidate is qualified. 

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. 

Certainty is rarely obtainable perhaps an AE with a positive rechallenge where there is objective evidence and an absence of confounders in an individual case would be considered as certainty due to the drug. In the majority of cases action is needed before there is absolute certainty that a drug can cause an AE. This lack of certainty in individual cases has been described suing rather vague terms such as almost certain , probably , possible , unlikely , etc. These terms have also been defined, but each author has a slightly different definition (Venulet et al., 1982 Stephens et ah, 1998). 

ISO defines validation as Conformation by examination and provision of objective evidence that the particular requirements for a specified intended use are fulfilled. This is decided by using a number of performance characteristics. These are specificity, linearity, range, accuracy, precision, detection limit (DL), quantitation limit (QL), and robusmess. System suitability testing (SST) is an integral part of many analytical procedures. Definitions of these terms based on the recommendations of the ICH Guideline Q2 (Rl) are given in Table... 

Most research papers that describe and conduct specific experiments, interpret experimental data, and evaluate the objective results of others, are often scientific in the nature and the tone of their writing style. In other words, these papers focus more on the accumulation of objective evidence, the various means by which data was tested and interpreted, and finally, the analysis of these results. Usually, these papers, by the specific nature of their subject matter and disciplines, are more focused in their scope. They are also more likely to be dictated in topic matter by a particular professor, professional discipline, or company. Some very broad ideas for possible topics in this area might include ... 

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