Corrective and preventive action
Introduction
Quality management principles, recognized world-wide, include a component for process improvement, comprised largely of actions taken to correct or prevent problems. Corrective or preventive action is usually initiated in response to a specific event with adverse consequences or a collection of events that trigger the desire or need to change. Customer and business needs typically drive the remainder of an organization’s process improvement efforts. In Transfusion Medicine opportunities to improve processes can come to light in a variety of ways. The following provide a wealth of information for possible corrective or preventive actions: error, incident, and accident reports, adverse reaction reports, customer complaints, process indicator measurements, and results of proficiency testing and internal or external audits, inspections, or assessments. The corrective and preventive action process includes identification of problems and their causes and identification and evaluation of solutions to prevent future problems. This article explores methods that can be used to create an effective corrective and preventive action process.
Section snippets
Definitions and concepts
A process is a series of actions, performed under certain conditions, using resources to produce a product or other output. Every process has `input', which is usually comprised of information and materials, the `performance phase' in which the activities or steps are performed, and an `output', which can be tangible, such as a product, or intangible, such as a service. The outcome is the resulting cumulative effect from performance or nonperformance of one or more processes. A system is a
Regulations and accreditation requirements
The importance of identifying and investigating problems is well-established and, in some instances, required. In the United States there are requirements that each blood establishment have a mechanism in place for reporting and investigating errors and accidents [4], [5]. The Food and Drug Administration (FDA) has further expanded their expectations regarding this requirement in a guidance document [6] as follows. Procedures for review, evaluation, investigation, and correction of
Identifying problems
The primary mechanisms used to identify problems in transfusion medicine are: reporting events, measuring process indicators, and performing process assessments. Errors, incidents, and accidents, adverse reactions, and customer complaints are examples of events that should be reported. Errors, incidents, and accidents can lead to adverse consequences in the manufacturing of products or delivery of services. They have the potential to adversely affect the safety, purity, potency, or efficacy of
Event classification
A method that can be used to glean further information about reported events is to classify them and look for trends. By enumerating all the events within a certain classification, one can get a sense of the most frequently occurring problems within a facility. Those occurring most frequently can then be targeted for corrective/preventive action. The most effective methods of classification involve use of multiple categories so patterns, previously not obvious, can emerge. For example, if the
Process indicators
A proactive approach to problem identification can be done through the measurement of specific process indicators. A process indicator is a specific performance measurement designed to monitor the stability of an existing process. Such indicators can be process-based or outcome-based. Process-based indicators measure the degree to which a process can be consistently performed. An example of a process-based indicator is a measurement of the turnaround time from blood product ordering until
Process assessments
Performance of internal and external audits, inspections, and assessments is another proactive approach to problem identification. During these types of assessments, examinations are made to determine if processes comply with requirements, are effectively implemented, and are suitable to meet defined objectives. Depending upon their focus, they can monitor only the output, both the process and the output, or can monitor related processes and their outputs, i.e. the system. In an output-focused
Process monitor summary
Fig. 3 illustrates the authors’ perception of how these different process monitors fit together. Each indicator represented in the figure monitors different aspects of the process. Adverse reactions, customer complaints and the results of proficiency testing are all indicators of process outcomes. Errors, incidents, accidents, and upstream events occur during the process, so are indicators of the process itself. Specific indicators put in place can be process-based or outcome-based.
Determining a course of action
Once a problem has been identified, there are several options: do nothing, implement remedial action, or investigate the problem to determine root cause with the intent of implementing corrective action. The decision is affected by: knowledge of the problem, the processes and the systems involved; risks (harm or potential harm to a patient, donor, or the business) and benefits; likelihood that such a problem (or similar problem) could recur; available resources; and organizational goals. In
Identifying the causes
Effective corrective action cannot be implemented until one evaluates a process in relationship to its related processes and defines the underlying cause(s) of the problem. This is called `systems thinking'. Russell and Regel [2] use a wonderful example to illustrate looking beyond the symptoms and tracing the problem back to the point of origin by using this thinking process. Their example goes like this:
After rearranging your furniture you note that the lamp next to your favorite chair won’t
Root cause analysis
Root cause analysis is an approach used to identify the underlying reason for an undesirable condition or problem. It can be done by an individual or group. The more complex the problem and involved the process, the greater the need to enlist a team of individuals and formalize the analysis. The team should include people who: perform the steps of the process, oversee the process, are knowledgeable about the process but are not directly involved in its performance or oversight, and are
Identifying solutions
Most problems, particularly those that are complex, have several root causes. When many causes are identified, a method that can be of use is the Pareto analysis. When this method is used, it is necessary to determine the frequency of: a) each cause or b) those items that contribute most frequently to the effect. A chart of these causes laid out in order of decreasing frequency is then prepared (Fig. 1 is an example of a Pareto chart). Those that occur most frequently are considered the `vital
Documenting
Documentation plays an important role in corrective and preventive action. A method for documentation that the authors have found particularly helpful is the use of a Process Improvement Form. This form is used to document follow-up on any identified problem for which it has been decided to initiate a corrective/preventive action. These problems can include individually reported events such as errors, incidents, accidents, and customer complaints, collections of events which have been trended
Summary
Opportunities to improve processes within transfusion medicine can present themselves in a variety of ways. Error, incident, and accident reports, adverse reactions, and customer complaints are events that should be reported, investigated if adverse consequences result, and evaluated for evidence of trends to identify process problems. Specific process indicators, as well as internal and external process assessments, are other methods that can be used to identify problems. Once identified, a
References (25)
- et al.
Error detection and reduction in blood banking
Clin in Lab Med
(1996) - Quality Management and Quality Assurance – Vocabulary (ISO 8402). Geneva, Switzerland: International Organization for...
- Russell JP, Regel T. After the quality audit. Milwaukee, WI: ASQC Quality Press,...
- et al.
Fix the process, not the problem
Harvard Business Review
(1990) - US Food and Drug Administration: Code of Federal Regulations, Title 21, Part 606.160 (b) (7) (iii). Washington, DC: US...
- US Food and Drug Administration: Code of Federal Regulations, Title 21, Part 211.192. Washington, DC: US Government...
- US Center for Biologics Evaluation and Research: Guideline for Quality Assurance in Blood Establishments. Rockville,...
- US Food and Drug Administration: Biological Products; Reporting of Errors and Accidents in Manufacturing – Proposed...
- US Food and Drug Administration: Code of Federal Regulations, Title 21, Part 606.170 (b). Washington, DC: US Government...
- US Food and Drug Administration: Code of Federal Regulations, Title 42, Part 405. Washington, DC: US Government...
Cited by (23)
A quantitative accident analysis model on nuclear safety culture based on Bayesian network
2022, Annals of Nuclear EnergyCitation Excerpt :Dew (1991) discusses three RCA tools: Process diagram, barrier analysis, and change analysis. Motschman and Moore (1999) address RCA processes in the field of medicine. Similar to other industries, the nuclear industry has been making efforts to analyze the root causes of events and implement CAPRs.
Analysis of trends of post-analytical quality indicators in Clinical Bacteriology laboratory: A pilot study from a tertiary care teaching hospital in Uttarakhand, India
2021, Indian Journal of Medical MicrobiologyCitation Excerpt :This would lead to evaluation of level of quality in the extra-analytical segment of total testing processes, thereby leading to better monitoring and tracking of areas of concern that need further improvement. Precise analysis and response to the QMS data can shed light on the nature of errors, thereby leading to valuable corrective and preventive actions or CAPA [8]. While corrective actions include the steps taken to remove the causes of an existing nonconformity, error, or other undesirable result, preventive actions are defined as the steps taken to remove the causes of a potential nonconformity, defect, or other undesirable result [9].
Preanalytic process linked to spuriously elevated HIV viral loads: improvement on an FDA-approved process
2017, Diagnostic Microbiology and Infectious DiseaseIdentification and development of Lean and Safety projects
2016, Safety ScienceCitation Excerpt :This last result is usually pursued by staff in charge of CRM, which, besides managing litigations and claims, should monitor, reduce and prevent patient harms, identifying and analyzing processes, and investing on the factors that positively influence the clinical practice (Mills and Von Bolschwing, 1995; Vincent et al., 1998). A corrective/reactive approach should be substituted by a preventive/proactive approach, alerting errors, and classifying, analyzing and controlling clinical risks as part of a systematic approach (Motschman and Moore, 1999; Foss and Moore, 2003). Therefore, the most recurrent problems and their underlying causes can be identified and appropriate actions can be executed to improve clinical processes.
Expert Cloud: A Cloud-based framework to share the knowledge and skills of human resources
2015, Computers in Human BehaviorA cross-sectional study on the relationship between utilization of root cause analysis and patient safety at 139 department of veterans affairs medical centers
2013, Joint Commission Journal on Quality and Patient Safety