5 FAQs about FRACAS
1. What does FRACAS stand for?
FRACAS is an acronym for “Failure Reporting, Analysis, and Corrective Action System”.
The term FRACAS has its roots in a Department of Defense standard published in 1985 that defined the FRACAS process, MIL-STD-2155. Therefore, FRACAS is a term widely used and recognized in industries related to military, defense, aerospace, etc. However, due to its long history and wide acceptance, FRACAS is used throughout many commercial industries as well.
2. How do I pronounce FRACAS?
Well, clearly no one wants to say “Failure Reporting, Analysis, and Corrective Action System” every time they want to refer to this process! And, actually, the term FRACAS is so well known and accepted in many industry sectors, that it’s lengthy title may not even be recognized.
In general, FRACAS is pronounced as “frah’-kus“. A second pronunciation also heard is “frey’-kus“. And, lastly, mainly in Europe, “frak’-ah” may be heard.
Confusion does result from the other meaning of the word “fracas”. Fracas is a synonym for the word “argument” or “quarrel”, and, in fact, Googling “FRACAS” often returns results all related to a brawl!
Watch and listen to the video on the various ways to pronounce FRACAS. In the reliability and quality field, the first pronunciation is used.
3. What is FRACAS?
FRACAS is a closed-loop management system to organize, track, and manage your process for handling and resolving problems or issues. The process begins with problem report and identification, progresses through identifying a corrective action, and finally concludes with implementing the corrective action to resolve the issue. Product-centered companies, large to small, engage in some type of closed-loop corrective action (CLCA) process. It may be formal or not, tightly controlled or loosely developed, but it exists in some manner.
The Steps of a FRACAS
The steps in a FRACAS, as noted by its acronym, include:
- Failure Reporting: a failure occurrence is logged in some manner.
- Analysis: the failure is analyzed to determine the cause.
- Corrective Action: the steps necessary to correct, prevent, or mitigate the failure in the future are identified, implemented, and verified.
The core of FRACAS is the step-by-step process of problem identification to problem resolution. If any step of the process is not completed – a problem is not recorded, a corrective action is not identified, a corrective action is not implemented – the loop is broken. Far too often, experiences with a broken loop leads organizations to implement a controlled, trackable closed-loop system. Over time, most companies realize the necessity of implementing a system to effectively manage the handling of reported issues. While the processes established vary tremendously, most corporations have settled on some type of software system to track and manage issues as they arise.
FRACAS: A Closed-loop Process
Closed-loop processes extend to a wide range of business areas: product testing, non-conformance reporting, compliance requirement tracking, handling product failures in the field, tracking manufacturing defects, and many other examples. In essence, your organization may have various types of processes to track and manage. While the type of issues being managed may vary, the general process remains relatively the same: an issue is reported, and then the problem is corrected in some manner. The number of steps between initial logging and final closure varies depending on your organization, your needs, the complexity of the process, the number of people involved, and, in some cases, compliance requirements. Additionally, the processes often develop and change over time as needs and requirements evolve.
Most organizations use a software tool to manage the FRACAS process. Sometimes, a homegrown method is employed. More often, an off-the-shelf FRACAS software package specifically designed for managing the FRACAS process is used.
4. What is CAPA (Corrective and Preventive Action) and how does it relate to FRACAS?
CAPA is also a closed-loop process for the management of failures or nonconformance. A CAPA process identifies actions to be taken to eliminate or mitigate failures or nonconformance issues related to procedures, processes, systems, or services in an organization. CAPA is closely tied to quality management.
In some industries, CAPA is required in order to meet regulatory standards. For example, industries such as pharmaceutical and medical devices have compliance requirements from the FDA that include having a CAPA in place. CAPAs also are part of many practices in the automotive industry. This is also the case for compliance with ISO standards, GMP and other Good Practices (GxP).
The 8D Process
While there is not a single CAPA standard, there are many process methodologies that are in use to support a corrective action system. A commonly known one is the 8D Problem Solving process. In general, 8D (or 8 Disciplines) is an 8-step methodology employed for process and/or product improvement. The 8 steps are:
- D1: Create a team
- D2: Describe the problem
- D3: Develop containment plan
- D4: Determine and verify root causes
- D5: Verify permanent solutions
- D6: Define and implement corrective actions
- D7: Prevent recurrence
- D8: Congratulate the team
Other processes are also used for product and process improvement. PDCA (Plan, Do, Check, Act) is a 4-step process also referred to as the Deming cycle or circle, and the Shewhart cycle. DMAIC (Define, Measure, Analyze, Improve, Control) is a continuous improvement system often used in Six Sigma programs.
Corrective Action Process Management
Many organizations also implement unique CAPA processes best suited to their needs and requirements. Regardless of the specific process employed, the goal of CAPA remains the same – to effectively manage problems or issues. The long-range goal is to ensure your organization is meeting quality, reliability, and continuous improvement goals.
5. What are the FRACAS and CAPA Standards?
There is not a single FRACAS or CAPA standard that is applied across the board. There are many standards that are industry specific, as well as general guidelines for high-level overview of implementation of a FRACAS process.
The choice of a standard may be made due to industry requirements, compliance needs, corporate objectives, historical reasons, or simply preference. In general terms, your issue management process is part of your quality management system (QMS), even if it stands alone or is part of an integrated quality platform. Oftentimes, it is helpful to look to technical associations or organizations that serve your industry for guidance and suggestions. Organizations such as ASQ (American Society for Quality) may be a good starting point.
MIL-STD-2155 FRACAS Standard
The MIL-STD-2155 standard is also a good reference. Entitled Failure Reporting, Analysis and Corrective Action System (FRACAS), establishes the criteria needed for a FRACAS that complies with the FRACAS requirement portion of MIL-STD-785. MIL-STD-785, Reliability Program for Systems and Equipment Development and Production, is a broad standard that offers general guidelines as well as specifics for reliability programs that span the product lifecycle. While these standards are military in origin, they are still used across many industries, and offer sound guidelines for a FRACAS process.
Meeting Compliance Requirements with FRACAS or CAPA
Many regulated industries and ISO certified organizations must have a CAPA process in place in order to meet compliance requirements. Standards such as ISO-9001, ISO/TS 16949, AS 9100, and policies that are part FDA, GMP, and QMS requirements, include the need for a defined and established FRACAS/CAPA processes.
It can be confusing with the terms such as PDCA, DMAIC, 8D, and Six Sigma also in the mix when FRACAS and CAPA are discussed. These terms designate process control methodologies. FRACAS and CAPA are process control management systems, so they can, and often do, implement one of these methodologies.
Relyence FRACAS fully supports both CAPA and FRACAS processes and offers a robust platform for tracking and managing your corrective and preventive action process. With out-of-the box support for 8D, DMAIC, and PDCA processes, as well as an easy-to-use built-in designer for building a completely custom process suited to your needs, Relyence FRACAS can capably meet the challenges of any of your FRACAS or CAPA requirements.