So you downloaded a product certificate from the exida website and you are trying to understand the information documented in the certificate. Also, you likely want to know what stands behind the certificate and what was involved in the certification of the product.
I’m not going to spend time talking about exida; you can find that on the website!
Let’s first discuss the step-by-step process of product certification. I’ll give you the “reader’s digest” version of the certification procedure:
Step 1: Kickoff Meeting
The exida project engineer will conduct a project kickoff meeting to review the steps that will be taken to achieve certification. This is typically done via a net meeting or conference call.
Step 2: Perform FMEDA analysis on product
A detailed Failure Modes, Effects, and Diagnostic Analysis (FMEDA) is a technique used to evaluate the reliability and safety integrity of a given product. The results of a FMEDA analysis are a set of failure rates and useful life that can be used to determine product and overall SIF probability of failure.
Step 3: Creation of the Proven In Use Analysis
For existing products, an exida engineer will review in detail the shipping and returns history of the products. The exida engineer will evaluate the existing return process, the details of the failure analysis, and document how the existing product has been sufficiently free of defects to be utilized in a safety rated application.
Step 4: Process Analysis
The process analysis is an initial step where an exida engineer will typically review the Customer Company’s quality management system procedures. Once it has been established that the quality management system procedures are in compliance to IEC 61508, the Baseline Safety Case is created. It is assumed that the Product have the same design and development procedures. The basis of the IEC 61508 certification of the Customer Company Product is a detailed Safety Case. On the basis of the Process Analysis an exida engineer will populate the Safety Case using the exida SafetyCaseDB tool.
Step 5: Onsite Audit
When all the process gap issues have been addressed, an on-site audit meeting is scheduled. The onsite meeting is expected to be conducted over 1-2 days. During the visit the exida engineer will review the existing development procedures in detail and interview the respective responsible parties to discover how the process has been applied to the Product. This information is entered into the Safety Case. If there are any audit findings, a gap report is issued.
Step 6: Certification Audit:
Once the evaluating assessor is satisfied that the gaps have been filled, an exida certification assessor will review the safety case to determine that all requirements have been met and that evidence documents exist. Once the certifying assessor is satisfied that the requirements have been met, either the evaluating assessor or the certifying assessor will create an assessment report and certificate.
Stay tuned for Part 2 next week, which will discuss the certificate itself…
Tagged as: steve close proven in use analysis product certificate process analysis iec 61508 certification IEC 61508 fmeda analysis fmeda failure modes, effects, and diagnostic analysis certification audit