Identify whether the QRM exercise is a prospective, retrospective, or change control QRM exercise.

Define the Item under study and the scope of the exercise. If possible, define a boundary for the Item under Study.

Provide relevant background information so that the reason for the QRM exercise is made clear.

State any pertinent assumptions being made, especially those relating to qualification and validation, and document any significant uncertainties associated with the data being used in the exercise.

Identify the QRM team leader and the other team members. The team should be multi-disciplinary and include persons knowledgeable in the item under study.

At least one person should have a firm understanding of the QRM process, its underlying principles, and the associated methodology.

If possible, there should be personnel on the team who have the necessary authority (or the means) to make key decisions regarding the implementation and funding of risk mitigation controls.

Review the default probability, severity, and detection definitions provided in this QRM tool. These are presented on a laminated card that accompanies the tool worksheet.

The team then decides whether those default definitions are appropriate for the specific QRM exercise at hand. New or modified probability, severity, and detection definitions can be drawn up, if required. For example, the definitions for probability of occurrence can be made quantitative, or the severity definitions can be altered to better reflect the concerns of any specific stakeholders.

A risk table (or matrix) is used by this QRM tool and this is also shown on the laminated card.

Review relevant documentation, records, and data, and use brainstorming techniques to identify potential negative events for the Item under Study.

As this is a formal and rigorous QRM methodology, only the highest priority/most important potential negative events should normally be selected for formal evaluation. To do this, the following approach may be used:

Discuss and review all of the suggested potential negative events identified above, in terms of their expected consequences and their likelihood of occurrence.

In this regard, the strength of evidence for the likelihood of occurrence of each potential negative event should be considered, and the severity of the consequences of each potential negative event should also be discussed.

The level of complexity associated with the each potential negative event, in terms of how the potential negative event might occur, should also be considered.

At this stage, those potential negative events considered by the team to be the most important, in terms of their potential consequences and/or complexity, should be selected for formal onward processing in the remaining steps of the QRM process. However, the likelihood of occurrence of each potential negative event should also be taken into account.

If it is considered that a potential negative event has only a remote likelihood of occurring, then this potential negative event should not normally be selected for onward processing through the remaining steps of the QRM process, unless there is good reason for doing so.

The decisions made in relation to the above evaluations and considerations should be documented.

In relation to dealing with any potential negative events not selected for onward processing through the remaining steps of the QRM process, a record should be made of what these potential negative events were, and why they were not formally routed through the remaining steps of the process.

The team may decide that any potential risks associated with these potential negative events should be managed in a less formal manner than this methodology requires, and information in this regard should be documented.

Alternatively, the team may decide that these potential negative events should actually be processed through the remaining steps of this QRM process at some later date, perhaps during the planned review of the QRM exercise as part of Periodic Review phase. This should be documented in Step 10 of the tool worksheet.

Alternatively, the team may just recommend that these potential negative events be reviewed again at the next review of the exercise, to determine whether at that time they should be formally routed through the remaining steps of the process. Again, this should be documented in Step 10 of the worksheet.

Lastly, there may be no need to give any more consideration to those potential negative events at all, following the above evaluation at Step 4 of their expected consequences and their likelihoods of occurrence. This should be documented.

For each potential negative event, identify and document its potential adverse consequences.

Document and critically evaluate any currently in place back-up or redundancy controls for the potential negative event, and assign a severity rating.

Identify and document the cause(s) of each potential negative event.

Document and critically evaluate any currently in place preventative controls for each cause, and assign a probability of occurrence rating to each cause.

Using the risk table provided on the laminated card that accompanies the tool worksheet, estimate each risk associated with the potential negative event.

This results in the classification of each risk as either acceptable, unacceptable, or intolerable.

Risks deemed to be acceptable progress directly to Step 8 of the worksheet; all other risks progress to Step 6.

Document and critically evaluate any currently in place detection controls for each unacceptable and intolerable risk.

Assign a detection rating to these controls, and assess whether these controls give assurance that the risk is adequately controlled and that no further controls are required.

Risks that are considered adequately controlled progress directly to Step 8. All other risks progress to Step 7.

Identify and critically evaluate any new or improved back-up or redundancy controls that may be put in place for unacceptable and intolerable risks.

With these controls in mind, assign a new severity rating to the potential negative event.

Identify and critically evaluate any new or improved preventative controls that may be put in place for the cause(s) of each unacceptable and intolerable risk.

With these controls in mind, assign a new probability of occurrence rating to each cause.

Using the risk table provided on the laminated card that accompanies the tool worksheet, re-estimate each risk.

This results in the reclassification of each risk as either acceptable, unacceptable, or intolerable.

Risks deemed to be acceptable progress to Step 8 of the worksheet; all other risks continue through Step 7.

Identify and critically evaluate any new or improved detection controls for each unacceptable and intolerable risk.

Assign a detection rating to these controls, and assess whether these controls give assurance that the risk is now adequately controlled and that no further controls are required.

Risks that are considered adequately controlled progress to Step 8.

For risks that are still not considered adequately controlled, Step 7 (Risk Control), should be repeated. (A redesign of the item under study may be necessary in order to eliminate the potential negative event.)

For each control listed on Worksheets No. 5, 6, and 7, identify the items (such as documentation, equipment, facilities, personnel resources, etc.), which are required for the control to be in place.

Determine critical process parameters, their limits, and any other acceptance criteria or required outcomes for each control.

Determine any training and assessment of training requirements for each control.

Determine any qualification or validation activities required for each control, and assign a qualification and validation status to each.

Document any action items arising out of the QRM exercise and assign responsibilities to each.

These may be actions required to implement a control, or they could be qualification or validation exercises.

Identify and document any communication activities that are required for the risks identified during the exercise.

Assign responsibilities and timelines for each communication activity.

Define when the QRM exercise should be reviewed as part of continuous improvement, and document any key areas or issues to be reviewed at that time.

Close out the QRM exercise.