The Quality Manual can be used to state the commitment and any policy addressing Improvements. Although a procedure is not mandatory, it is a commonly used non-mandatory procedure. This is because it is an important quality management system activity and you need to show evidence on how you consider, action and evaluate opportunities for improvement. This should be covered under the procedure Addressing Risks and Opportunities.
2. What data should be included in the context of Improvement data analysis
For each potential opportunity, a benefit / risk evaluation should be performed. Inputs to the evaluation will be both subjective (knowledge of the system) and objective (for example client requests, contract requirements, strategic decisions).
The record Registry of Key Risks and Opportunities, or similar, plus any other supportive records such as risk evaluation matrices should be used. The objective is to decide if the opportunity is worth the possible risk of change. Because the actions taken are required to be proportional to the potential impact, you can use a 3 x 3 risk and a 3 x 3 opportunities matrix for the evaluation to semi quantify the evaluation. Start with the benefit score. For example do a 3 x 3 opportunity evaluation where High = 3 points, Med = 2 points and Low = 1 point. Consider Probability of successful implementation against Positive Impact. Multiple the probability and impact points to determine the Benefit points. Decide on a scale, for example if the Benefit points = 1 or 2 it is low, 3 or 4 is medium and 6 or 9 is high benefit.
Then do the Risk Score. For example do a 3 x 3 Risk evaluation where Probability of Risk if you implemented the improvement change (High, Med, Low) against Severity, i.e. negative impact if implemented the improvement change (High, Med, Low) where again High = 3 points, Med = 2 points and Low = 1 point. Multiple the points. Decide on a scale, for example if the Risk Score is 1 or 2 it is low, 3 or 4 is medium and 6 or 9 is high risk.
Finally perform the overall Evaluation, which is a Benefit / Risk Ratio to guide your decision. State your approach, for example only implement if Low Risk and High or Medium Benefit; do not implement if benefit is Low or Medium and Risk is High; for all other cases evaluate further. Remember this is not a policy to adhere to, but a guidance, to assist the laboratory decide (on a risk basis) which improvements to implement. Evaluating further will involve looking at how much resources will be needed, in terms of time and finances. These discussions could take place during management review.