CRM plan

Is there a CRM plan in place, is the plan agreed, signed-off and being kept up to date ... 

Where a variation to the process is considered, this should be formally documented in the CRM Plan for each system under assessment along with the rationale and jnstihcation for the variation. The process documentation itself could also set out any basis for omitting relevant steps. Building in process flexibility at the time of SMS development facilitates the straight-forward justification of the approach when one applies the process to a product. 

The CRM Plan - setting out the safety activities which one intends to conduct... 

The CRM Plan is typically the first formal safety deliverable issued during a project. It fundamentally sets out the basis for the rest of the CRM activities. Note that the plan is not necessarily the same as the process. The process and SMS are agreed at an organisational level as a standard template or menu of CRM activities. The CRM Plan specifies the next level of detail - how the process will be applied to the particular product under consideration. 

The CRM Plan should state or reference the agreed intended purpose and in this way contribute to the boundary setting of the CRM analysis and safety case. As a minimum a HIT system s intended purpose should include ... 

The deliverables produced during the assessment of a product should include a CRM Plan, hazard register and safety case. 

The CRM Plan should state the intended purpose of the product, define the boundaries of the assessment, state any assumptions and summarise the overall approach for the product under examination. 

This section will nonnaUy set the scene and rationale for undertaking the CRM assessment. This serves to put the report into the context of the overall project and product lifecycle with reference to key milestones. It is often appropriate at this point to refer back to the original CRM Plan for further context setting. 

The intention to develop staged reports should be set out in the CRM Plan for the project. For example, one might choose the following schedule ... 

The participants The range of participants should, whenever possible, be chosen in such a manner that widely different methods (based on different physical or chemical principles) can be used. The number of participants (recommended 15) should be sufficient to allow meaningful statistical processing of the results. When the laboratories feel the need for a CRM, either because the available calibrants are not comparable and a primary calibrant appears necessary for traceability, or because a reliable certified control material is needed but not available, then it is recommended that these laboratories do not plan a certification project entirely on their own, but that they involve laboratories having a background in traceability. 

Figure 7.27 shows that only a few participants indicated that they used a tuna bsh CRM for QA. Forty percent of the participants using a CRM for QA, compared to 30 percent not using a CRM, reported Hg results within 5 percent deviation from the certibed reference value. Final conclusions on the measurement performance according to the use of CRMs could be drawn if all results were corrected for recovery. Unfortunately this information was not available. It is planned to get information on recovery correction from IMEP participants in future IMEP ILCs. 

The availability of ad hoc CRMs can substantially contribute to the credibility and comparability of experimental information obtained in Antarctica. The global investment made in this remote continent in terms of human and financial resources, and the crucial role played by Antarctic studies in the interpretation of phenomena on a planetary scale do demand that no questionable data be generated or circulated. It would be thus desirable that other countries undertake similar programmes and stimulate the major producers of CRMs to support and participate in such initiatives. International planning and coordination in this context will definitely provide additional evidence of Antarctica as being as a land of peace and science. 

CRM suppliers such isochronous tests can be planned and can be repeated over time. For the study of new materials this approach is not suited as the probable instability is only known at the very end. For the development studies on storage and behaviour of the material rapid answers are necessary. 

Fig. 4.14. The road-map for the isochronous measurement of stability shows when the bottles have to be taken out from the initial storage temperature of -20 to be set at the increased destabilisation temperature. At the end of the production, 100 bottles are set aside at -20 °C (could be lower e.g. -80 C). After the homogeneity study (month 0), 5 bottles are stored at each of the studied temperatures. Here a very extensive temperature study is performed (+4, +20, +40, +80 °C), usually materials are tested at room temperature and +40 °C unless feasibility studies have revealed risk of instability. After 6,9 and 11 months each time 5 more bottles are added at each storage temperature. All bottles (100 in total) are analysed together. Such a study can be planned over three years instead of 12 months. When the analyses do not reveal instability a new study can be started in the same conditions taking as time 0 the end of the measurements of the first study. The disadvantage of such an approach is that the study reveals a possible instability only at the end. Therefore, it is hardly usable for the development and first production of a CRM. It is an advantageous approach for the monitoring of stability by the suppliers as it allows an easy planning of the laboratory work if several materials have to be followed [49].

We have already established that the undertaking of a CRM project should be conducted in a controlled and logical manner. Importantly the project should be carried out not in isolation but as an integrated component of the general product lifecycle or implementation. For these reasons wider project plans should contain explicit references to the CRM activities especially in the Project Initiation Document (PID). 

Most well-managed projects have embedded within than a series of gates or milestones. These events usually have defined inputs and outputs with explicit expectations that certain materials and decisions will have been completed by that point. The gates are included in the project plan - a document owned by the project manager. It is into these gates that the output from the CRM analysis will feed. In this way the CRM project team is tasked with producing a clear set of deliverables at specific points in the project - formally agreed material which other workstreams will consume and utilise in their own work. These dependencies are important to define at the start of a project so that if timescales are unexpectedly drawn out the impact on other stakeholders can be quickly ascertained. 

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