How well is your demonstration material organised? Is the certificate still valid? Are the calculations you made still cover the change? These questions can be directly be answered when compliance management is applied. Compliance management controls and manages the documentation that proofs the product’s compliance with its requirements in an efficient and traceable way that, whenever there is a change, the validity of the compliance statement can be granted. Changes are, for example, modification of the product or regulation changes. With a clear compliance management system the impact of changes can be determined in a quick way and thus ensuring the design integrity and a valid certificate. Therefore the compliance demonstration needs to be maintained throughout the product's life cycle.
Proof of product compliance
Showing compliance of your product with requirements starts with a clear plan what to demonstrate. Beside the design requirements, the requirements consist of governmental rules, company rules and customer requirements. For each requirement it is determined how it can or need to be demonstrated, this is called the means of compliance. The means can be: the drawing itself, calculations, simulations, tests, or a combination of means. If dealing with governmental rules and you are deviating from the requested means of compliance you need to submit your plan to the respective authorities for acceptance.
The compliance material needs to be planned and collected. The demonstration of compliance need to be unambiguous clear. Sometimes witnessing of tests is obliged by authorities and this need to be arranged in time to avoid delays of the approval. If the demonstration material is prepared and collected it need to be verified and approved internally, then accepted by authorities and finally accepted by the customer. If the compliance material is not clear and ambiguous then the approval and acceptance process can result in a time consuming process.
Why is compliance management needed?
1. to ensure design integrity throughout the product life cycle
2. to prevent repetitive certification work
How to ensure design integrity?
Does your new design or existing product comply with the current rules given by the government or other recognized authorities or even your own company’s standards? What part of your product has been demostrated with calculations or tested in a test bench to proof the functionality or endurance and fatigue life? Can you find the materials that were used for the demonstration of strength and fatigue and are they in the current design still from the same alloy? Is your demonstration material still valid? If you have a transparent management of your compliance file, changes in the design or the production of the design, are easy to trace and you can grant the design integrity.
How to prevent repetitive certification?
Organize your demonstration of compliance material! Besides, if you organize it and you make procedures and rules how to maintain the material, you have developed your compliance management system.
When is compliance management needed?
• if engineering teams on different locations make use of the same compliance demonstration;
• for products that have a Type Approval;
• for products that are part of a product family, to be able to re-use demonstration material;
• for products that are involved to ensure safety of people or environment (during operation/maintenance);
• for complex products existing of different systems that affect correct functioning of the product;
• for products that need to comply with requirements from different authorities/customers;
• for product improvements to achieve the next level of maturity (product development).
How to implement a product compliance management system?
1. Determine the compliance demonstration method that is used for the product; this can be direct reports from tests and calculations gathered into one file, or it can be set up in a cascade, a break down structure.
2. To be able to control the current status of the demonstration of compliance from a certain design, it needs to be secured and version controlled.
3. Arrange a procedure how to deal with changes and make revision rules: criteria when a document is allowed to be changed.
4. Arrange an approval and release procedure and authorized persons that are allowed to approve modified documents.
Note! If you are dealing with international teams, it is currently a prerequisite to have an integrated computer network that shares the product data. This demands authorization levels in your PDM system to protect your design from accidentally modifications by unqualified colleagues.