Testing and analysis provides the assurance evidence that the device can meet the specified requirements and that any uncertainties associated with the performance of the device have been addressed such that the residual risk is acceptable to the end user.
Testing and analysis can be used to obtain evidence of device function and performance, including reliability performance and definition of operability limits. Testing is also used to verify that materials and manufactured parts conform to specification.
The RAPAT “Planning” worksheet can be used to plan for testing/analysis at a high level (schedule, resourcing, budget, etc.) whereas the RAPAT “Testing & Analysis” worksheet is intended to support more detailed planning and reporting of each test/analysis. It is important to identify any required testing and analyses as early as possible to enable these to be resourced and scheduled appropriately.
The testing and analysis plan should be based on both the requirements for the device and the identified technical risks. For some applications, the relevant regulations, codes and standards will specify the required testing and analyses that need to be undertaken for certification/acceptance. For novel technology, a FMECA should be used to identify the potential failure modes and associated mechanisms/causes - this should then be used to identify tests and analyses appropriate to each specific failure mode and mechanism, e.g. corrosion, fatigue and wear.
For each specific test/analysis it is important to identify:
A more detailed test/analysis procedure can then be developed specifying the procedure to be followed together with any pass/fail criteria.
At the top of the RAPAT “Testing & Analysis” worksheet, the “Testing & Analysis Sheet Completion Status” will initially be set to “Not started”. Use the dropdown list to change this to “In progress”, or “Completed” as appropriate.
Populate the “Test & Analysis Plan and Record” table, adding further tests/analyses using the “Add Row” button in the right-click context menu as required. The dashboard at the top of the worksheet automatically tracks progress of the tests/analyses.
The testing and analysis plan should be thought of as a living document which is reviewed and updated on a regular basis to ensure it reflects the device development status and the current status of each test. As the development of the device progresses, additional tests and analyses may need to be added to the plan, or defined tests may need to be modified.
For each test/analysis, updates should include:
When searching for a laboratory to commission your testing activities with, the competence of the laboratory chosen may be critical to your product meeting the users' requirements and/or gaining certification. It is therefore important that the laboratory has been accredited by an independent third party. Most commonly, laboratory accreditation use the internationally recognised standard ISO 17205 to assess the competency of the laboratory to produce precise, accurate and reliable test results and data. Therefore, when choosing a laboratory, ISO 17205 accreditation is an important factor to consider. The standard ISO 17025 relates to laboratory quality systems and should not be confused with the internationally recognised quality management standard ISO 9001. It should also be noted that a laboratory is only accredited for the activities that are listed on their schedule, any activities undertaken outside of this will therefore not have been undertaken by an ISO 17025 accredited body which may consequently impact the certification of your product.
