As a product developer it can be confusing to understand the requirements placed on you by IEC 61508 to ensure that a device is designed with safety certification in mind. Even identifying the appropriate Safety Integrity Level (SIL) for your product can be a challenge. =Method can be engaged at any point during the product development lifecycle to support you through the product certification process.
=Method can provide independent assessment and invaluable guidance to ensure that when your product is ready to go to market there will be sufficient evidence to satisfy the 61508 requirements and it can be certified as SIL capable. The following aspects are considered during the Compliance Assessment process:
The first stage of the compliance assessment programme, no matter what stage in the design lifecycle the project is at, will be to conduct a gap analysis workshop. The output of this assessment is evaluation of the compliance of your current design with the relevant IEC 61508 requirements, identification of any non-compliances and potential corrective measures.
The final stage in all “new” product assessments is a formal Compliance Assessment against the IEC 61508 requirements. The output of this assessment is a formal Functional Safety Assessment Report which will, if appropriate, be accompanied by a =Method Product Certificate of Compliance.
Early engagement will ensure that functional safety is considered appropriately from the start of the design process, reducing the overall cost and effort required to achieve SIL certification at completion of the product design process.
If there are aspects of functional safety or IEC 61508 that you feel need clarification or persons with responsibility for functional safety require an internationally recognised qualification, =Method can offer training, either in-house or at one of our scheduled training events. Information on TUV Certified 61508 Training.
Determining whether it is possible to certify your existing product or product range to IEC 61508 can be a challenge, particularly if the product was not designed with functional safety in mind. =Method can offer two routes to certification for existing devices: Proven in Use and Retrospective Assessment.
The =Method Proven in Use route to certification is suitable for products which have been in the market for a lengthy period and for which reliable data on the failures in the field is available. The requirements in IEC 61508 for Proven in Use are known to be complex and tricky to apply, however =Method can support you with their expertise and experience in Proven in Use assessments.
The first step is evaluation of the field data to determine whether it would be possible to generate a defensible argument based on the evidence available. This assessment considers the volume of operating hours in the field for the products, the method by which failures and faults are recorded and the confidence in the quality of the recorded data. If =Method determines that the data available for the device is suitable and sufficient, a Proven in Use assessment can be conducted to determine the maximum possible SIL compliance that can be assured.
=Method will provide guidance in meeting the requirements of IEC 61508 additional to the quantitative analysis e.g. development of a Product Safety Manual.
If the initial step to evaluate the data set for a product determines that the Proven in Use route to certification is not achievable, =Method are able to offer an alternative option; retrospective assessment of the device against the requirements of IEC 61508. The following aspects are considered during the Compliance Assessment process:
The first activity is to conduct a gap analysis workshop. The output of this assessment is evaluation of the compliance of the product design with the relevant IEC 61508 requirements, identification of any non-compliances and potential corrective measures. This stage is key to understanding whether it will be possible to certify the product without modification or whether adjustments to elements of the design will be required and the volume of additional evidence that may, or may not, need to be generated for the certification process.
The final stage in all “existing” product assessments is a formal Compliance Assessment against the IEC 61508 requirements. The output of this assessment is a formal Functional Safety Assessment Report which will, if appropriate, be accompanied by a =Method Product Certificate of Compliance.
If there are aspects of functional safety or IEC 61508 that you feel need clarification or persons with responsibility for functional safety require an internationally recognised qualification, =Method can offer training, either in-house or at one of our scheduled training events. Information on TUV Certified 61508 Training.
support@methodcompass.com
+44 (0)1462 713313