An in-depth risk assessment of any project can be conducted by our highly trained engineers at Autocal Ireland. We evaluate the risk for each function of a system in the event of worst case scenarios. This process classifies the criticality of each risk and we suggest the protective measures to ensure that courses of action are put in place to minimise the effect of the risk. Our study is a means to identify potential hazards to a process or product, both prospectively and in a reactive mode. Risk assessment is an effective tool in supporting the decisions of which functions/sub functions in a large system require formal validation testing. A thorough process mapping exercise followed by thorough risk management follows.
As part of a risk assessment plan all possible risks, GXP and business risks, must be established. It must also be established under what situations that theses risks may occur and what level of impact they exert.
Six Sigma Approach to Continuous Improvement
Once a risk management plan has been developed and implemented, focus can now be shifted onto approving the processes that are already in place. As part of the continuous improvement to all process Autocal can implement a strategy to implement the six sigma approach when assessing possible improvements within a venture. Using six sigma we are constantly trying to achieve quality that strives for near perfection, as six sigma is a disciplined data driven approach and methodology for eliminating defects in any product, from manufacturing to transaction and from product to service.
The fundamentals of any six sigma project are the implementation of a measurement based strategy that focuses on process improvement and variation reduction through application of either of the two six sigma sub-methodologies DMAIC and DMADV.
