Every successful business has a reason for existence, a long-term mission/vision, and corresponding goals. The bridge between the Mission/Vision and the business goals is the business strategy. Strategy is commonly defined as a plan of action or policy designed to achieve a primary or overall aim or a general plan to achieve one or more long-term or overall goals under conditions of uncertainty (Oxford Languages). It helps to form detailed business objectives to meet the business mission.

The business mission will directly inform your Quality Policy. The Quality Policy is a “static” general statement that is made to support regulatory or statutory requirements. It describes the commitment to deliver a product that meets specifications, meets high product quality standards, etc.… and is always aligned with the business.

One critical reason for creating a quality strategy is to begin translating the quality policy and the business strategy into actionable, meaningful quality goals and objectives. Often the quality strategy and the objectives/goals that come out of it are packaged as the “Quality Plan” (See Figure 1)

OK – so at this point…how many are still reading? Before we get into the dangerous territory of “blah, blah, blah…”, let me describe a specific example of where the quality strategy was perfectly aligned with the business strategy and quality policy and created an actionable, successful quality plan. And then let me describe when it suddenly wasn’t aligned…and the *exciting* aftermath….

The business strategy was clearly defined to include the globalization of the quality management system (QMS) across multiple sites. Each site was geographically and culturally different, and the regulatory requirements varied (some were in a more regulated space than others). Key interviews with appropriate stakeholders were completed, and the pain points and risk tolerance of the business were well understood.

With that understanding, as well as the quality policy being documented, the quality strategy was developed to include the creation of a hybrid QMS, where some procedures would be global and some would be localized – all based on business risk and how the business wanted/needed control of and visibility into each site. For four years, the quality plan reflected this strategy – tweaked each year to reflect the improvements and addition of new sites. A fully functioning globally harmonized QMS was implemented. And then…

The business strategy changed. It wasn’t an announced or formal or even final change, but the signs were there. An acquisition had been completed, and the acquired company had two additional sites and a QMS that was not fully harmonized between the two sites.

That should have been a BIG sign, right? If the newly acquired business didn’t value/prioritize a harmonized QMS – then why would it support being a part of one?

With “enough” of the key stakeholders’ feedback, the quality team went away to update the quality strategy, it reflected the same basic strategy as before – bringing the two new sites into the hybrid QMS. Unfortunately, key stakeholders weren’t aligned in their feedback. And is relatively common in such business changes; it wasn’t even clear who the main stakeholders now were. The business strategy was ultimately determined – to allow the new business to run as independently as possible, with as much oversight as needed, without additional resources, to control the risk. The essential quality strategy was not aligned – and needed considerable refinement to support the new business strategy.

And I couldn’t do it. I was, personally, fundamentally misaligned with the rationale. 1. The acquired business doesn’t want to harmonize – my head said – neither did the other sites when we started – but they were now part of a high-performing team. 2. The acquired business was under a different regulatory expectation – my head said – it’s 90% the same and isn’t a difficult transition – why overcomplicate it? Needless to say, a new quality leader took the quality strategy and team and moved forward.

This is an extreme example of the outcome of a misaligned quality strategy, but it highlights an important principle. The quality strategy must be aligned with the business in order to be successful.At its best, it will drive performance and business success; at its worst, it will result in confusion, misalignment, and wasted resources. Quality strategies are not static and are not one-size-fits-all. They need to change with the business and its stakeholders and can be transformational in the best and sometimes worst ways.