Enterprise Quality Management • August 9, 2022

Stuff Happens, But Don’t Let It Happen Again and Again: MES and CAPA

Elizabeth Da Costa Elizabeth Da Costa

We’ve all learned that these days, more than ever before, stuff happens.  In the last couple of years, the COVID pandemic-induced labor and supply chain shortages, the war in Ukraine, and inflation have wreaked havoc on manufacturing.  Much of manufacturing has been slow to change.  After all, the phrase “if it ain’t broke don’t fix it” was the operating mode for many manufacturers. Manufacturers, particularly small to mid-sized enterprises, have had to develop agility and flexibility and most relied on technology to help them with the challenges of the last several years and the reality is it will likely remain a turbulent economic environment for several years more.  The trick to getting the most from your technology investments is that when stuff happens, and you turn to technology to help you cope, you need to ensure that you ensure that the fixes you put in place remain in place.  This is why you need not only a corrective action plan but a preventative action plan or CAPA program.  It isn’t enough to fix a problem, you need to keep it from happening over and over again.  This is why one of your technology investments needs to be a Manufacturing Execution System solution, with a strong quality focus.

Fool Me Once, Shame on You

Process upsets occur.  Whether it is machinery failing, parts failing quality checks due to improper setup, or other anomalies, manufacturers must deal with quality, production, or performance issues on an almost daily basis.  In many industries, raw material variability is a challenge while in others with extremely tight tolerances, variations in ambient temperatures, equipment voltage levels, or other seemingly inconsequential or even noticeable variances may cause significant quality issues.  Every time an exception occurs, the root cause needs to be identified.  In many cases, the exceptions are unanticipated and outside the normal expected behavior of the process.  Once the problem is identified the opportunity to take corrective action is present.  This is the corrective action step in the CAPA process.

Fool Me Twice, Shame on Me

As the saying goes, we need to learn from our mistakes.  While being prepared for every eventuality might seem like the best defense against process upsets, practicality such as the cost to analyze every possible failure point and putting in preventative measures might be prohibitive.  But, when upsets or failures occur, manufacturers need to put in place the guardrails that will preclude repeating the failure time and time again.  This is the preventive action step of the CAPA process.  In many respects, this is the harder part of the effort.  Trying to redesign a process so that variables that may initially seem out of your control such as raw material variations or power fluctuations during heat-induced grid failures will not impact production or quality can be quite challenging. This is the role of a robust CAPA process.


When failures occur it is important to not only correct them but to put in place the alarms, triggers, and processes that will preclude them from occurring in the future.  While some quality solutions have the capacity to document a CAPA process, your process planning and execution system (MES) is in a better position to actually ensure that any CAPA processes are actually executed.  When the MES has the capability of connecting to the process and constantly monitoring it — and then guiding operators through the steps to avoid a potential upset — you will be in a far better position to make the preventative part of CAPA reliable.

TEC: The Digital Manufacturing Operations Imperative

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