Streamlining CAPA Processes: Manual Systems vs. Automated Solutions


The real challenge in managing corrective and preventive actions (CAPA) isn’t knowing whether or not you’re making the right decision or the wrong decision. It is understanding if you’re making smarter and better decisions. There are any number of ways a manufacturer can handle a quality event, but what is most crucial is that the organization is in the best possible position to effectively deal with that event.

Effective CAPA management isn’t about making the right decisions, it’s about
how thosedecisions are made. How efficient are your CAPA processes?

Take your company’s customer complaint handling process, for example. How is your organization prepared to handle a customer complaint about a product that warrants the initiation of a CAPA? From a customer perspective, the solution should be as simple as finding the source of the problem and fixing the issue. In your actual experience, however, the overall process is much more complex and demanding. There are a number of complicated steps that need to be taken when correcting problematic issues and preventing their recurrence. How these steps are managed—and how efficiently they are handled—differs dramatically between manual (paper-based or paper/electronic hybrid) systems and automated CAPA systems. 

The Manual Method

When a complaint merits the launch of a CAPA, most organizations manage the process more or less according to a progression similar to the one outlined below:
  •        Complaint is received, recorded and, when applicable escalated to a CAPA
  •     A standard CAPA management procedure is initiated
  •     Cause is determined as a single event or a recurring, systemic problem (if applicable, this may entail a product failure investigation)
  •      Corrections are made, the process is recorded in a management report (or an action plan, in the case of a preventive action), and potential preventive measures are taken.

Even with this seemingly straightforward approach, such a process can be surprisingly laborious with a manual CAPA system. At each step along the CAPA path, there are decisions that need to be made to ensure that the complaint is addressed and that the proper adjustments are made to prevent similar difficulties in the future. A closer analysis of each step reveals more about the time, resources and level of expertise or authority required to propel the CAPA’s advancement through the process. 

This article is related to the Demo: MasterControl CAPA Software .
Complaint Recording with a Manual System

Each complaint must be logged and assigned a unique identifier. (It is worth noting here that even if complaint-related data is maintained on computerized systems, it is still a manual system if complaint and CAPA data are maintained and managed within disparate systems.) These customer complaints inevitably come from a variety of sources (email, phone calls, corporate website, contact with sales reps, etc.) and may languish in someone’s inbox interminably, especially if there is no formal procedure for processing them. Without a cohesive system that is structured to completely capture information in a timely manner, it is almost impossible to formulate an adequate strategy for resolution.

Launching a CAPA with a Manual System

If organizational guidelines dictate that the particular complaint should trigger the CAPA process, an entry is then created on a CAPA form. Again, even though these forms may be maintained in a computerized network, the system is still a manual or hybrid paper-electronic system unless CAPA forms can be launched directly from the complaint. The more groundwork required to initiate a CAPA and determine which issues are pertinent enough to be registered in the CAPA system, the less efficient and more prone to error the system will be.

Root Cause Determination with a Manual System

There are many questions that need to be asked in order to ferret out and eliminate a root cause. Are multiple elements needed to completely remove the problem? Will the solution completely remove the root cause? Is there a possibility that the solution will introduce new problems? These are just a few of the questions that need to be addressed during root cause analysis. And if your manual CAPA system isn’t integrated with the overall quality management system, there will be considerably more legwork and trial and error involved in finding the answers you’re seeking.

Implementing and Documenting Corrective and/or Preventive Actions with a Manual System

Documentation and the implementation of new work orders, SOPs, etc., means more paperwork. And with manual systems, more paperwork means more headaches and more wasted man hours. During this phase of the process, all the factors that come into play (i.e., communications, resources, approvals and timelines) can quickly amalgamate into a convoluted mess if the system isn’t structured to allow managers to easily determine answers to such questions as: Who needs to be “in the know” about this CAPA? Is the participation of other departments required? Who should be involved in the approval process? When does action need to be taken and what happens if the CAPA is left open too long? Answers to these questions can be hard to come by if you’re forced to dig through piles paper files or jump back and forth between information housed in disparate systems.

Automated CAPA Processes

Now contrast the time and resource allotment required to fulfill each of the phases outlined above with comparable steps taken when using an automated system.
Complaint Recording with an Automated System

Automation formalizes and standardizes complaint handling. An electronic system can be set to launch complaint-triggered CAPAs based on predetermined risk-based thresholds. All customer complaints and subsequent documentation pertaining to the investigation and correction of the problem can be entered into a central repository. Having all this information stored within a single, cohesive platform makes the search and retrieval of complaints and complaint-related data almost instantaneous. Plus, if the system is web-based, complaints and corresponding information can be entered from virtually anywhere.

Launching a CAPA with an Automated System

When each element of the CAPA process is electronically connected to the rest of the quality system, it takes far less time for the entire process to transpire. CAPAs can be launched directly from a complaint form as soon as preset thresholds are triggered. This dramatically reduces both the time and resources required for data entry as well as the human errors that can be introduced during the transfer of information. Links are maintained electronically which provides added visibility for managers who wish to review the overall process to see what initially triggered the CAPA, how the process is progressing, and so forth.

Root Cause Determination with an Automated System

With an automated CAPA system, root cause discovery is simplified because it is easier to recognize the absolutes that
must be satisfied and distinguish them from the desirables you hope to satisfy but are not absolutely necessary to resolve the issue. And if bringing the issue to resolution quickly is just as important as resolving it effectively, an automated system will readily outperform any manual system.

Implementing and Documenting Corrective and/or Preventive Actions with an Automated System

The keys to preventive actions are: 1) the thorough examination of each cause that has been singled out and 2) the identification of means of preventing those potential problems from ever occurring again. Focusing on the area of highest impact is the best starting point for reducing the possibility of occurrence. These types of activities are simplified greatly by automation because all the required CAPA data is centrally and electronically available. The entire life cycle of the complaint process is reduced by an electronic system that streamlines each step and consolidates all the sources of complaints under a single platform. Additionally, the analytics and reporting functionalities provided by an automated system are invaluable during this phase of CAPA.

A customer complaint, it should go without saying, is only one of many quality issues that may trigger a CAPA. This is just one example of a process that can be dramatically streamlined through automation. Any other occurrence that has a negative impact on quality, such as nonconformances, deviations, issues discovered during an audit, or other similarly adverse events, could be substituted for complaints in the examples above. So consider the wider scope of your overall CAPA processes and quality management systems and ask yourself, “For all the time, effort and resources my organization devotes to CAPA management, are we getting our money’s worth?”

This informative video provides additional insight about the impact of automation on CAPA processes.

Learn more about MasterControl's CAPA Software Systems.

James Jardine is a marketing communications specialist for MasterControl Inc. He has a bachelor’s degree in journalism from the University of Utah and is based in MasterControl’s headquarters in Salt Lake City, Utah.