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Product Verification
Control of Production
It is an essential part of many Product Certification Schemes that type examination and control of production are integrated to give assurance that manufactured products (as well as the design) comply with the requirements of the specified standard.
Under the requirements of the ATEX Directive (as well as many other EU Directives) the proper integration of the two aspects is broken and they are treated separately, possibly even involving different Notified Bodies.
Since most of the work of Baseefa is concerned with ATEX and IECEx, we have split our services accordingly. However, we remain of the opinion that the best guarantee of obtaining conforming product is that a single Notified Body should take responsibility for both the design and the production aspects, thus avoiding the potential problems of a split in that responsibility.
This guide is concerned with control of production, using direct product verification techniques, where a Notified Body undertakes the responsibility of inspecting each manufactured product to confirm compliance with stated requirements.
Where we undertake responsibility for control of production outside the scope of the ATEX Directive, the procedures applicable to the ATEX Directive will apply unless specifically modified.
At the time of writing this Guide, The IECEx Scheme has not yet developed a verification scheme but relies entirely on the concept of Production Quality Control. However, the scheme has initiated discussions on the subject and, as soon as permitted, Baseefa will offer product verification within the IECEx Scheme.
Product Verification
The object of Product Verification is to provide assurance that the manufacturing process results in each manufactured product being in compliance with the certified design specified in a Type Examination Certificate. Making compliant product is the responsibility of the manufacturer, but assurance of compliance is provided by independent verification of critical features of the manufactured product. This verification will either be performed by our staff or by others acting on our behalf and under our direct supervision. On successful completion, a Product Verification Certificate is issued, listing each compliant product by serial number.
Unit Verification
The object of Unit Verification is to provide assurance that single items of manufactured product comply with the requirements of specified standards. In this case, there is no separate Type Examination Certificate and the Unit Verification Certificate combines aspects of both a Type Examination Certificate and a Product Verification Certificate.
For most purposes, particularly if it is anticipated that more than one item of equipment will eventually be produced, it will be appropriate to follow the path of separate type examination and verification. However, for complex single items of equipment, it may be advantageous to follow the path of unit verification since the drawing requirements can be reduced. The need is to describe the manufactured product, not to provide drawings showing manufacturing tolerances for future production.
We suggest that if you are contemplating the route of unit verification, you discuss the implications with us before proceeding too far.
Throughout the remainder of this document, we refer only to Product Verification. This should be taken to include the relevant aspects of Unit Verification.
The Verification Process
The process of verification will vary considerably, depending on the nature of the item under production and the relevant standards or protection concept(s).
However, it will follow the following principles:
1. We are verifying that each produced item, individually, complies with the specification laid down in the Type Examination Certificate and its associated documents. Therefore each and every produced item must be subject to the process.
2. Where the full verification cannot be performed on the completely manufactured item (for example, after encapsulation), it will be necessary to perform the appropriate part of the verification process during production.
3. Because the verification process is invoked as an alternative to a quality system approach, it will only be possible to make limited use of your quality records.
4. Although most of the activity will relate to the checking of physical dimensions, there may be a need to perform tests on some items. (For example, the overpressure test for flameproof enclosures.)
5. The person performing the verification will record the results of the verification process as it progresses. Optionally, we can prepare a summary report, to accompany the Verification Certificate. We will retain the full records.
6. On successful completion of the verification exercise, we will prepare a Verification Certificate, identifying the verified product by type and serial number(s). Where appropriate, the addition of marking will normally be supervised by us, or on our behalf.
7. When verification is to take place other than at our Buxton laboratory, the use of measuring equipment supplied by others may be relevant, but only if we are able to satisfy ourselves with regard to the calibration status and fitness for purpose of such equipment.
Quotation and Order
An application form for verification services is available which should assist you to provide us with the information we need to prepare a quotation. Use of the form is not obligatory, but we will need to have the same information in some other way. The terms and conditions applicable to the verification process, given at the end of this document, apply whether or not the application form is used.
Based on the anticipated schedule of availability of product and our assessment of the work required to verify each product, we will prepare our quotation.
If you wish to set up a scheme for a routine verification activity, please talk to us and we will make specific arrangements.
Assuming that verification is completed as anticipated, the quotation will allow for the issue of an appropriate Verification Certificate (or Certificates). In the event that there are problems with compliance which requires us to perform additional work, or to perform a repeat examination, we will provide a further quotation.
The options for payment are similar to those for type examination work and, for verification at the time of type examination, may be integrated with the payments for type examination.
Terms and Conditions
1. All product verification work is subject to the General Terms and Conditions of Baseefa which are confirmed as applicable on registration. In addition, the following specific terms and conditions apply.
2. We will prepare a quotation based on the information available to us. We reserve the right to charge additional fees, should there be any changes, such as:
a. Delay in supply of product;
b. Splitting of anticipated batches of product;
c. The need to repeat work because of non-compliance.
3. You may request termination of the verification process at any time. We will assess the value of work done and refund any unused fees.
4. You must retain the certificate and any associated documents for your future reference. Certain legislation, for example the ATEX Directive, places a legal requirement on you to retain these documents for a stated period (normally ten years) after the date of production.
5. We will retain copies of the documents as part of a Technical File for a defined period in accordance with our service for retention and storage of technical files.
6. We may withdraw a certificate if :
a. It is discovered that it should not have been issued (either through false information provided to us, or through our own error).
b. You fail to abide by these terms and condition.
7. Baseefa Certificates bearing the crown and tick logo relating to national accreditation of certification bodies by the United Kingdom Accreditation Service (UKAS) indicate that the work leading to the issue of that certificate has been done in accordance with the accreditation of Baseefa by UKAS. It should not be construed that the product, system or device to which that certificate relates has been approved by UKAS.
We reserve the right to publish information on Product Verification Certificates that are issued and withdrawn.
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