Annex 1 requires that processes, equipment, facilities and manufacturing activities should be considered in accordance with the QRM principles. This is a proactive means of identifying risks and scientifically assessing the risks. This expectation requires the development of an effective contamination control strategy (CCS) based on a scientific assessment to understand the process. In Annex 1, the terms "risk", "justification" and "strategy" are used, which underlines the importance. Now, a year later, we look back and forward. Keeps the strategy what it promises or prescribes.