A focus on compliance is necessary for Life Sciences companies. Complying with regulations is a core part of their \u2018right to operate\u2019, making it possible for them to manufacture and sell their products. But manufacturers that focus exclusively on compliance at the expense of other core quality objectives put themselves at significant risk. <\/p>\n\n\n\n
A compliance-only focus risks failure in other quality areas such as product quality, safety, efficacy and continuity of supply. They may also lose sight of the goal, which is delivering safe, effective, high-quality products to the market quickly and consistently. <\/p>\n\n\n\n
Manufacturers that balance compliance with a broader set of quality objectives, contributing the necessary resources to each area, are much more likely to achieve all key objectives at the same time. <\/p>\n\n\n\n
Here\u2019s how you can do the same. <\/p>\n\n\n\n
Identify the Right Key Performance Indicators (KPIs) <\/strong> <\/p>\n\n\n\n When it comes to measuring performance, companies often strive for a \u201cbalanced scorecard\u201d\u2014where the internal functions of a business are achieving the desired external results. However, in quality operations, if a manufacturer\u2019s scorecard is focused solely on compliance, then it is inherently out of balance. The measures do not sufficiently address core quality objectives: <\/p>\n\n\n\n In other cases, a manufacturer may develop KPIs that measure the efficiency rather than effectiveness of its operations. Measuring how fast a task is completed is far easier than measuring whether an action had an impact on product quality and safety. To strike a balance between quality and compliance, Life Sciences manufacturers must establish KPIs<\/a> that go beyond checking a compliance box. These KPIs must get down to the root cause of quality issues and measure how effectively the company addressed them. Given the increasingly outsourced Life Sciences supply chain, companies must also have KPIs focused on supplier quality performance<\/a>. <\/p>\n\n\n\n Manufacturers with KPIs that balance compliance with quality have the insights necessary to address all five quality objectives. Furthermore, quality teams can show executive leadership that their role goes well beyond compliance scorekeeper, and they can impact organization-wide performance. <\/p>\n\n\n\n
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