The mechanism in which change is assessed and implemented must be carried out in a planned and systematic manner6 and consider several areas, including why the changes are being made and possible outcomes, how the QMS may be affected, as well as how this change will be resourced appropriately6. In the pharma industrys quality systems, these stipulations (as well as several others) are already incorporated, however, for some businesses this may be a new way of working. In many change control processes, an interesting consideration is the potential for unintended consequences that result from the change being implemented. The process approach integrates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking to enable an organization to plan its processes and their interactions. Simply stated as per the standard, the PDCA cycle allows an organization to ensure that its processes have sufficient (managed) resources and opportunities for improvement are identified and resolved5. Many organizations across all industries focus on structured, documented processes and strict compliance to appropriate standards, but sometimes a very critical element is stated, but yet not practiced holistically. Alas, that is not management per se, but leadership. As noted previously, top management has a defined set of responsibilities for the QMS. Evidence of those responsibilities must be present. How that is documented or demonstrated by objective evidence remains the organizations decision, but there must be evidence of this being accomplished. The increased responsibilities of leadership are not only the responsibility of quality management, but top management. Although every day we live in the world of regulations, which govern the manufacturing and distribution of pharmaceutical products, attention should be given to ISO 9001:2015, with particular emphasis on presence/absence of certification as well as how your suppliers demonstrate adherence. The goal is the same for both supplier and industry customer satisfaction, and consistent, conforming (quality) goods and/or services.Visit for more information on ISO 9001:2015, visit ASQ Quality Management Standards .
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