Verification, conformity

The highest level for conformity verification and acceptance in Europe are the voluntary product safety and EMC Approval Marks, issued by European notified and competent bodies. The Approval Mark is backed by an official test report and certificate from a European accredited body (OJEC). 

European harmonized standards ( EN listed in the Official Journal) shall be used for CE conformity verification... 

Where conformity assessment involves intervention of third party, that task is normally carried out by the notified body. The pressure equipment directive enables in addition the national authorities to authorise in their territory user inspectorates for the carrying out of conformity assessment procedures which relate to product verification. These inspectorates shall act exclusively on behalf of the group of which they are part. The placing on the market and putting into service of equipment which has undergone such assessment is however limited to the territory of the authorising Member State and to those Member States which have also proceeded to such authorisation. The equipment concerned shall therefore not bear the CE-marking. 

The GMP details certain requirements for the quahty system, such as the independence and responsibihties of the quahty control unit. It requires such activities as internal audit to monitor GMP conformance, employee training, complaint investigation, failure analysis, and verification of proper manufacture and test by QC prior to release of the batch. 

This also implies that verification of conformity cannot be extended over several audits - each requirement has to be verified on the initial audit. 

The standard creates a distinction between design verification and design validation. There are two types of verification those verification activities performed during design and on the component parts to verify conformance to specification and those verification activities performed on the completed design to verify performance but more on this later. 

As part of the verification plan, you should include an activity plan that lists all the planned activities in the sequence they are to be conducted and use this plan to record completion and conformance progressively. The activity plan should make provision for planned and actual dates for each activity and for recording comments such as recovery plans when the program does not proceed exactly as planned. It is also good practice to conduct test reviews before and after each series of tests so that corrective measures can be taken before continuing with abortive tests (see also under Design validation). ... 

The control plans should make provision for any specific controls required by the customer and these must be implemented. Evidence is required to show that all the controls specified in the control plan have been implemented and a way of doing this is to make provision for recording verification of conformity against the relevant requirement in the control plan. 

It should also not be assumed that these requirements are only intended for implementation by a department with the title Inspection or Test. Whenever a product is supplied, produced, or repaired, rebuilt, modified, or otherwise changed, it should be subject to verification that it conforms with the prescribed requirements and any deficiencies corrected before being released for use. That is what control means. Control is not just the inspection part of the process and hence quality control , which for years was the name given to inspection departments, was misunderstood. Inspection and test don t control quality. Inspection and test merely measure the quality achieved and pass the results to the producer for remedial action. 

The standard requires that the supplier ensures that incoming product is not used or processed (except in the circumstances described in 4.10.1.2) until it has been inspected or otherwise verified as conforming to specified requirements and requires that verification be in accordance with the quality plan or documented procedures. 

This requirement poses something of a dilemma when purchasing subcontract labor because it cannot be treated the same as product. You still need to ensure, however, that the labor conforms with your requirements before use. Such checks will include verification that the personnel provided have the requisite qualifications, skills, and knowledge and they are who they say they are. These checks can be made on the documentary evidence provided, such as certificates, but you will probably wish to monitor their performance because it is the effort you have purchased, not the people. You will not be able to verify whether they are entirely suitable until you have evaluated their performance. Subcontract labor could be classified as product released prior to verification being performed and so you need to keep records of the personnel and their performance during the tenure of the contract. 

The verification carried out, however, has to be in accordance with some plan. The standard requires firstly that you verify conformance and secondly that you should do it in accordance with some plan or other. Your plans, therefore, need to prescribe the acceptance criteria for carrying out such verification. If the standard required that you verify conformance in accordance with the quality plan, as it does in clause 4.10.3, it would give you the option of not specifying any measures at all in your quality plan for verifying conformance, but this has been covered by the requirements of 4.10.1 as already explained. 

It would be considered prudent to prohibit the premature release of product if you did not have an adequate traceability system in place. If in fact any nonconformities in a component will be detected by the end product tests, it may be worth allowing production to commence without the receipt tests being available, in which case the tests will only be confidence checks and not verification checks. If only one product is received and released prior to verification one would think that, as the requirement applies prior to verification, there is no need to positively identify the product to permit recall because you would know where it was if you found it to be nonconforming. However, the nonconformity may have been reported to you by the supplier after delivery. The standard does not stipulate when and by whom the nonconformity may have been detected. If you lose the means of determining conformity by premature release, don t release the product until you have verified it is acceptable. 

Should you not use measuring devices in your organization, these requirements will not apply. If your means of verification are limited to visual inspection or professional judgement, as is the case with organizations that deal only with documentation, you will have no devices to control. However, you may use tools or computer software to assist you to determine conformance and these will need to be proven capable of producing a reliable result. 

You are only required to indicate whether product conforms to the inspections and tests performed. This is not the same as indicating whether the product conforms to the customer requirements. It may well pass the prescribed inspections and tests but these inspections and tests may not be sufficiently comprehensive to verify conformance to all the customer s requirements. However, the only indication you can give is the product s conformance or nonconformance with some verification requirement. It follows therefore that you should not go around putting reject labels on products, or acceptance labels for that matter, if you have not performed a specific inspection to determine conformance. There are only three conditions uninspected , inspected and found conforming , and inspected and found nonconforming . If you have a policy of only applying labels after inspection, anything without a label is therefore deemed uninspected, unless it has been installed and the label removed. 

With software the verification status can be denoted in the software as a comment or on records testifying its conformance with requirements. 

The EC type-examination is the process that the manufacturer may use to obtain independent verification that a design conforms to essential requirements, when a certified QA system has not been applied to the design process. The manufacturer must submit an application to the notified body, accompanied by documentation on the device design and physical samples of the device. The Notified Body examines the... 

EC verification provides an alternative to the model of establishing a certified production QA system. Independent testing of either all devices, or a statistically representative sample of each batch, is conducted by or on behalf of the Notified Body, which then issues a certificate of conformity for the tests conducted. This is not a popular option due to the costs involved. The procedure is not capable of providing adequate assurance as to the sterility of devices. Instead, an assurance of sterility must be based on the application of a production QA system to the sterilisation process. 

NMR spectroscopy has been widely used for identification of optically active Schiff bases.15-18 It is also a valuable tool for determination of their conformations, suggesting the reaction pathway or simply for verification of their purity.19-22 Selected examples are given below. 

The computational verification and prediction of the conformations (tertiary structures) of polypeptides presents a considerable challenge for theoretical chemists. Attempts towards this goal have so far made use of force field calculations to a large extent. Levitt... 

The laboratory shall define the characteristics of the materials, reagents and instrument to be purchased and evaluate the ability of the eligible suppliers to supply the required materials and/or services. The verification process that is, the process to ensure that the purchased products conform to the defined requirements shall be defined and the necessary resources, including persormel, shall be provided. 

Based on the verification process already defined, upon receipt of purchased material the laboratory inspects and verifies that the received materials conform to the purchase requirements. When the verification is made at the supplier s premises there is a need to make arrangements for such verification and for a definition of the method for the release of products. 

---