A Simple Prescription to Manage Your CAPA Process

It's a real pain in the neck! 

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Some days you just don't feel quite right. You and your team are overloaded with corrective and preventative actions (CAPAs). There is a continuous history of not delivering these on time and fully completed - quite often due to people in other departments failing to address their CAPA action items. You know these improvements will make your company more effective and more competitive, but your CAPA system just isn't working.

Time to write yourself a prescription.

I'm not talking about self-medicating, but a simple method that will garner support and participation throughout the organization and deliver results. It requires perseverance on your part - after all, if it were too easy everybody would already be doing it.

This prescription consists of 2 steps:

  1. Stop doing

  2. Start doing

℞ #1 - Stop Doing "everything"

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Many QMS are set up to require Corrective Actions for every Non-Conformity that comes along. The result is CAPA overload for all concerned. Overload people with what they consider to be trivial and not a good use of their time and they will balk at these requests and delay.

As with any aspect in management, you need to focus on and accomplish your highest priorities to produce the highest return and optimal results. Focus on those CAPAs that will deliver the biggest value to the organization. Quality, not quantity is the key. Of course there are certain CAPAs that are mandatory in order to maintain your certification. These are by definition high value, so focus on these. The priority list will vary depending on the business you are in, however a good starting point is:

  • safety related actions

  • customer complaints

  • processes operating outside of their control points

  • external audit findings (typically major and critical observations)

  • repeat issues (prioritized by their effect on customers and on cost to the company)

Not every non-conformity requires a corrective action (to better understand how to use CAPA effectively read our article NCR, CAR, SCAR, CAPA, PAR What's the Difference). To start with, if you find yourself with too many CAPAs, perform a one-time assessment and close all those which are not critical or move them to an improvement action item in your management meetings. This way you can deal with them as time permits but there is no full-fledged investigation required which devours your resources.

℞ #2 - Start Doing

Let's take some action to get some relief.

℞ - Prioritize your CAPAs.

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Once your one-time assessment is completed, keep CAPAs from building up by prioritizing. There are several aspects to take into consideration:

  1. Compliance - CAPAs from external audits most often need to be performed within a fixed time frame. Otherwise you may compromise your certification.

  2. Risk - Many of the latest revisions to the international standards now require you assess risk in your QMS. Actions that pose a higher risk (health, safety, environment) to the company if not corrected should be given a higher priority.

  3. Contribution - Corrective actions that bring higher returns to the company, either from increased efficiency (higher throughput) or lower costs should form the next priority.

Work on the highest priority first and continue until it's done. If you find you can't proceed any further with your highest priority, put it aside and work on your No. 2 priority. Do not multi task! Do one thing at a time where thought is required.

℞ - Focus on finding the Root Cause.

CAPAs typically comprise 3 parts: containment, root cause analysis and the execution of the corrective/preventative action. The root cause analysis often is the most time-critical and leads to the biggest improvement gain.  

Containment may be costly in the short term but it can often be implemented in short order and have the outcome of your process back on track. Don't spend a lot of time finding the cheapest containment. Find something that works and focus on the root cause.

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Fixing your process - getting to the root cause - is where the real payoff is and where you need to focus your efforts. Involve people from other departments who own their part of the process. Don't be afraid to give up the lead on the project to the best person qualified. Not only will it help free up your time, it will gain momentum and buy-in to the continual improvement process. And don't be stingy with praising their success even if much of the credit belongs to you. The goal is continual improvement going forward and people want to work in teams where they are appreciated.

℞ - Prevent future accumulation of CAPAs

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Invest in technology like CIS Software to save time, manage your processes and maintain accountability among the stakeholders. Why waste time getting feedback, writing reports and following up on action items when technology will do all that for you? With built-in linkages to work orders, progress reports and automated emails, CIS is a huge time and money saver. The investment is small and the return is huge.

Change your procedures to match your business. The reason you have chosen to follow standards (ISO 9001, GFSI, FSSC, AS 9100) is to exceed customer expectations and make your company better. Make sure you conform to requirements but make sure your policies and procedures are working for you. Again, look at technology to help lighten the load.

℞ - Free up some discretionary time

As a manager, you get paid to focus on and accomplish the most vital priorities in producing optimal effect. What's this mean? Understand what your company's top priorities are. Work on those CAPAs that have a direct impact on those priorities.

Carve out more time to work on these. Free up some discretionary time (time where you decide how you spend it) and work on those high priority goals:

  • Look at where your time goes. Keep a time log for a week (get your team to do this as well). Every 1/2 hour categorize where you spent your time. Were you working on those vital priorities? If not, why not? This one action alone will allow you to make fact-based decisions on where you are spending your time and what activities are low value (that can be delegated or dropped).

  • Start every day with a new to-do list. Prioritize each item and make time to work on the ones that will have optimal effect. Often you will find that yesterday's urgencies have taken care of themselves.

℞ - Keep management informed and be adaptive

Having a well-documented process and reporting structure (technology again to the rescue) will allow you to gain the full buy-in of the management team. Keeping them up-to-date keeps them connected and part of the continuous improvement process. They see measured progress, agree with the priorities, can make resources available and you can manage their expectations.

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Things change and stuff happens. More pressing issues might arise once your plans are set.  You need to be adaptive in the speed of execution and the prioritizing of the corrective/improvement actions. The low and medium priority actions allow you the most flexibility to accommodate change. A change in plans requires either a change in resources available to you, or a change in the priorities, or the removal of some actions from your list. By regularly and formally discussing this with management you will be in a much better position to champion focused continuous improvement in your company.

Get well soon

By following this simple prescription to a more focused approach to continual improvement, you will become more effective as a manger and your company will become more competitive. Your focus will change from being a fire-fighter to a problem-solver. CAPAs will no longer manage you and there will be fewer of them to deal with.

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The true benefit of continuous improvement is always driving for value generation. By focusing on those activities which bring the biggest value, and involving the key process stakeholders wherever and whenever possible, your workday will be more rewarding and you will unleash the creative powers of your co-workers.

Doesn't that make you feel better already?

Source: https://www.HorricksManagementGroup.com