Source credit: https://www.bsigroup.com/en-GB/blog/Personal-Protective-Equipment-Blog/technical-file-review/

Authors:

Antony Field- Certification Manager, PPE


Jo Wood – Certification Manager, PPE (Fire)

 

As part of the certification activity it is usual to undertake a Technical File Review. This review can apply to any certification process, be it Kitemark; Verification or any of the other schemes offered by BSI. This blog explains more about this process; the importance of the technical file in certification and also how it benefits you as the client!

A technical file is a collection of controlled documents that relates to a single product or range of products and generally contains, but is not limited to, technical specifications; test reports; drawings; quality plan; user information and any health & safety advice (including environmental advice where applicable). To ensure the currency of the technical file this should have a title page/front sheet with revision status and date and a contents page listing all documents, with a revision status and date. We also need to know where products are made (factory location) if this is not the certificate location or head office.

Certification relating to European Directives will have additional document requirements and these will be reflected in a more complex technical file.

The client should keep a copy of the product Technical File for inspection by auditors to ensure it remains identical to the one held by BSI. This then becomes the formula for the certified product and any future changes are noted, updated and if they affect the product in anyway, then tested to ensure continued compliance. It may be that alternative suppliers are used for materials or components and these references and documents should be included in the Technical File.

Test Reports will be initial type tests carried out at the start of the certification process and should cover all variations in materials / component suppliers. Type test reports will generally include drawings / materials data to confirm the product specification. Subsequent audit tests will be checked against these type tests. Audit tests are based on limited clauses from the standard to ensure relevant aspects of the product are maintained and it continues to match the original product specifications.

The Quality plan reflects the product lifecycle and can include stages such as manufacturing / storage / shipping / marking and use. This is commonly part of the quality management system and will be referred to and audited against during the BSI auditor assessment visits.

The certification application will include a request for these documents and drawings and generally these will be the technical file. We will review these and compile a review report to ensure that the specifications and drawings match the samples as tested to baseline the product. This product ‘version’ is then established and fixed as the Kitemarked product.

This report will be added to your file to show that we have reviewed the documentation associated with the application, from your name and address, the quotation number associated with the work, through to the manufacturing location, product description, test reports, assessment visit report and quality plan. This document is important when we ourselves are audited as it provides a roadmap of how the assessment and certificate recommendation was formed. This aids you because all the relevant documents are referenced and easily located and becomes the blueprint for your certified product ensuring future production can follow the same ‘recipe’.

If there is a requirement to update, modify or change the product, then an application should be made to BSI so that we can assess the changes and advise if further documentation, information or testing is needed.