... or Random Road Trips?

You have a deviation, you conduct an investigation, you get to true cause, and now you need to choose and implement a CAPA. How often do your CAPA choices deliver the desired results? How many of your deviations reoccur? How well planned are your CAPA implementations? How many CAPA projects are completed on time, on cost, and on performance? Are your CAPA choices and implementation plans well thought out journeys or hopeful adventures?

Good projects begin with good decisions and good planning. Good decisions and good planning require a good understanding of where you are before you begin and where you want to be when you finish, your goals and objectives. Before we choose a CAPA, we need to understand the underlying issues we need to resolve. Do we really know the cause of the deviation? How confident are we that the chosen CAPA is the best alternative for achieving our goals and objectives? The analogy might be, we are in Boston, we are not happy, let’s drive to Chicago, IL. Do we really know why we are not happy in Boston? Why do we think being in Chicago will be better? Why not Atlanta, GA? Why not training on living in Boston? A common understanding of the need for and value of change results in better buy-in and alignment of resources.

Once you decide on a CAPA, you need a plan for how to implement it. What work needs to be done to implement the CAPA? What route will we take to get to Chicago, toll or toll-free, direct or scenic?

What resources (people, facilities, equipment) and how much of them (time on task, $) will be needed to complete the work to implement the CAPA?What vehicle will we use to get to Chicago—comfortable or economical, fast or steady? What sort of people do we want to take with us? How much will all that cost? Accurate plans and cost estimates allow organizations to better allocate resources and minimize the impact of projects on the organization.

With a plan in place we can now determine which individuals or groups we would like to have involved in the CAPA implementation and how much of their time we will need. The question is, are they available when we want them? How much time can they allocate to the CAPA project? Who do we want to have on the ride to Chicago? When are they available to go to Chicago, and how much time will they have for the trip? What else are they working on? When can they start?

Now we have enough information to complete a timeline: understanding the project’s goals enables us to determine the work required; knowing the work allows us to calculate the effort and resources required; from people’s availability to complete the work we can estimate a timeline. Understanding people’s availability and using that information to create accurate timelines minimizes the probability that timelines will be pushed out and stakeholders will be disappointed.

Before we get started, we might want to consider a risk assessment. Have we missed anything? Is there any additional work we can do prior to getting started to minimize the probability of risk later in the project? Perhaps we should service the vehicle, stock up on necessities, and check road conditions and weather. How can we prepare to mitigate the seriousness of risk should it occur? What insurance and road side service agreements do we have? Is the spare tire functioning?

Although risk-free projects are an unrealistic expectation, having a good understanding of the risks allows us to avoid going back to our sponsors and asking for more time or more money, or worse reducing the scope of the project once we have started.

Once started, how will you measure your progress as you implement the CAPA? In many organizations, project progress is measured by time spent and resources used. The analogy might be how many miles you drive each day and how much you spend along the way. The challenge is that time and resources spent, are not necessarily a good way of tracking progress. The analogy might be after day one we have driven 500 miles in 8 hours, half way. But, are we in Buffalo, NY, or Washington DC? From Buffalo, it is another 500 miles and 8 hours to Chicago. From Washington, it is 700 miles and 12 hours. And if we are in DC, how did we get there?

Is it a question of not having a good plan to start with, or “scope creep”? A change in project scope is not necessarily a bad thing if all stakeholders understand and agree that the additional time and cost provide sufficient value. But, if we are in the wrong place, the sooner we know about it, the sooner we can react and minimize re-work and additional cost to the organization.

Simple CAPAs may not require as much thought and planning as complex CAPAs, but no thought and no planning may well result in no results. Even a road trip from Boston to Chicago requires some planning; else you may end up stuck on the side of the road or in Albany, not that Albany is a bad place, it’s just not where you had hoped to be.

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Beyond Compliance: sing cGMP Compliance to Improve Business Results

John Ager, a Kepner-Tregoe consultant, specializes in business process redesign and facilitating critical issue resolution for both service and manufacturing organizations. Mr. Ager has led client projects that have resulted in improved compliance with FDA regulations, increased manufacturing efficiency, optimized organizational structures, and alignment of employee activities with organizational priorities.