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Application interpretation of CAPA in quality management of sterilization supply center
GUIDE INTERPRETATION | Updated：2023-02-22
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    • Application interpretation of CAPA in quality management of sterilization supply center

    • Zhiru Zhang

      ,  

      Qin Wang

      ,  

      Lin Jiang

      ,  
    • Sterile Supply   Vol. 1, Issue 3, (2022)

    • DOI：10.11910/j.issn.2791-2043.2022.3.02    

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  • Zhang Zhiru,Wang Qin,Jiang Lin.Application interpretation of CAPA in quality management of sterilization supply center[J].Sterile Supply,2022,01(03):86-90. DOI： 10.11910/j.issn.2791-2043.2022.3.02.

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    Abstract

    This article systematically introduces the background and procedures of the quality management CAPA tool and compares it with the common quality tools used in sterilization supply, discusses the application of CAPA in the sterilization supply center, and helps to achieve the quality prevention and management level improvement of sterilization supply.

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    The sterilization supply center is known as “The heart of the hospital”. High quality sterilization supply service can effectively reduce the infection rate and mortality rate of patients, ensure medical quality and safety, and quality management is the core of its whole process control. In China, quality management tools such as quality control circle and PDCA cycle have been widely used in the field of sterilization supply, while CAPA has not been reported in this field as an effective tool. Therefore, this article introduces and discusses the origin, construction and characteristics of CAPA, hoping to provide reference for related research and management of practitioners.

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    1 CAPA Background

    CAPA is the abbreviation of Corrective and Preventive Actions, it refers to taking actions against existing or potential nonconformities or unexpected situations to prevent their recurrence and occurrence. Its definition originated from the US FDA quality system specification 21CFR820.100[

    1], which is the most important implementation hotspot in the GMP quality system formed by the long-term practice of European and American pharmaceutical enterprises. However, it is further clear and definite in ISO 13485:2016[2]. International ICH Q10, ISO/IEC 7025 and other influential quality system standards, as well as China’s GMP, have requirements for establishing a CAPA[3]. In 2009, with Synergy Health Plc entered China as an international sterilization service provider, CAPA began to be applied in the field of disinfection supply in China.
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    As a system of reactive and active dual loop operation, CAPA incorporates the concept of risk management, including the three independent concepts in Table 1, which can also be understood as a three-tier response that’s interrelated but relatively independent. All passive error correction and active prevention are subordinate to it, including any management involving process, service, detection and quality, with emphasis on prevention. In short, CAPA is to prevent reoccurrence and occurrence of nonconformities. The implementation of quantitative change leads to qualitative change of quality management to a new level, that’s the essence of CAPA.

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    Table 1  Three Independent Concepts in CAPA
    No.ConceptDescriptionPurpose
    1 Correction Remedial actions for the discovered nonconformities.

    Solve direct issues

    Save for the moment

    2 Corrective Action Actions taken to eliminate nonconformities or other undesirable situations with identified root causes.

    Stop germination in time

    Prevent recurrence

    3 Preventive Action Actions taken to prevent potential nonconformities or other unexpected situations.

    Prevent issues before they occur

    Prevent occurrence

    Is the most fundamental action

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    2 CAPA Procedure

    Based on the above and in combination with the actual application of the sterilization supply center, a set of practical procedures conforming to the quality management of sterilization supply is formed, which is divided into nine steps as shown in figure 1.

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    fig

    Figure 1  Nine steps of procedure CAPA

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    2.1 Issue Identification

    In order to take effective action, first of all, it is necessary to identify the issue or potential issue, identify the sources accurately, and take appropriate statistical methods to confirm and detect the issue if necessary. These issues may come from all directions, such as nonconforming products, complaints, review feedback, preventive matters for continuous improvement, trend audit results of disinfection and sterilization quality data sources, etc. In order to evaluate and ensure its accuracy, the exact evidence of the issue shall be confirmed and recorded during identification.

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    2.2 Correction

    Once the issue is identified, it should be judged at the first time whether immediate response is required, this “Fire Fighting” remedy is Correction. If necessary, the confirmed nonconformities shall be corrected immediately before risk assessment, to weaken and maximize reduction the continuous impact and loss of nonconformities in a timely manner. If unnecessary, it can directly enter the risk assessment beyond correction.

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    2.3 Risk Assessment

    Before Initiate CAPA, risk assessment must be carried out to determine the risk level, severity, impact and urgency of the issue. In the process of disinfection and sterilization, when any nonconforming product or adverse condition is identified as a risk or potential risk, or the quality data becomes an unexpected trend, or there is an opportunity to eliminate the cause of the possible unacceptable nonconformity, defect or adverse condition, it is necessary to start CAPA to investigate and respond. Even if it’s not necessary, the reason shall also be described, recorded and ended.

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    2.4 Initiate CAPA

    After CAPA is initiated, it is necessary to establish a CAPA team (can cross departments) and determine whether root cause investigation is required. If the risk level is low, the sterilization supply center can determine the CAPA team leader by itself; if it is found by the health administration department or the health law enforcement department, or the risk level of infection outbreak is high, the sterilization supply center shall jointly confirm the CAPA team structure and investigation plan with the management or the director in charge or the competent department. If the risk level is high, such as the health administrative department or health law enforcement, or the outbreak of infection, etc., the team structure and plan of the CAPA shall be jointly confirmed by the sterilization supply center and the management (or the director in charge or the competent department). If the root cause investigation is not required, the CAPA plan can be identified directly.

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    2.5 Investigate for Root Cause

    2.5.1 Issue Investigation

    Effective corrective and preventive actions can be formulated only after the root cause investigation is clear. In order to accurately determine the root cause, the investigation activities should not be limited to all persons, matters, materials, etc. responsible for and related to non-compliance, issues, improvement opportunities, etc., sometimes also rely on the understanding of sterilization supply process, equipment design and consumable parameters. In this process, if any information that changes the risk is found, it is necessary to re analyze the risk.

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    2.5.2 Root Cause analysis

    Presenting the cause and effect is the difficulty and core of CAPA investigation. The root causes can be divided into three categories in Table 2, its comprehensive analysis shall be conducted from the aspects of Manpower, Machine, Method, Material, Measurement and Environment (5M1E), and the correlation between them. In the actual sterilization supply, it is necessary to analyze whether the disinfection and sterilization procedures are correctly followed, whether the existing procedures are sufficient, effective and appropriate to identify or prevent the occurrence or recurrence of the root cause, determine whether similar products and treatment processes are affected by the same issue. If “yes”, check whether the preventive actions are properly analyzed. If the root cause cannot be found temporarily during the actual investigation, corrective actions should be taken for the most likely one or several causes.

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    Table 2  Three Types of Root Causes
    No.TypeDescription
    1 Confirmed where data clearly supports this as the root cause.
    2 Concluded where data exists to support this conclusion, but cannot be confirmed, or 3;
    3 Potential Contributor where the root cause cannot be confirmed or concluded but considered related to the event and CAPA are planned to mitigate this potential in the future.
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    2.6 Identify CAPA Plan

    CAPA plan includes all corrective actions and preventive actions that need to be taken based on the root cause. The actions should correspond to the impact of the issue and related risks. All proposed actions should be revalidated to ensure that there will be no adverse impact on the qualified items. CAPA may also be started due to peripheral reasons such as suppliers or customers. The CAPA team should confirm the plan content with them and update the batch number, release notes or potential failure modes in a timely manner. In addition, in order to inspect and confirm the effectiveness of CAPA implementation, the CAPA team should also develop an effectiveness plan.

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    2.7 Implement CAPA Plan

    After approval of the CAPA Plan, the source document such as complaints or sterilization data can be archived. Each party shall implement the assigned actions according to the approved CAPA plan and target end date. If the actions cannot be completed by the assigned deadline, the basis shall be recorded and the new CAPA plan shall be approved.

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    2.8 CAPA Tracking Confirmation

    After the implementation of CAPA, it shall be tracked regularly and reported to the Health Commission, Quality Supervision and other functional departments in documents. In addition, CAPA needs to be reviewed and verified according to the effectiveness plan prepared in advance to assess whether the root cause has been successfully solved and can be eliminated sustainably. If it is invalid, it shall at least return to the root cause investigation for recycling; In case of delay, the CAPA plan shall be prepared at least for re approval.

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    2.9 CAPA Close Out

    CAPA can be closed only when it is confirmed that all the corrective actions have been completed on time and are effective. The “completion” here not only includes the completion of all the corrective actions, but also includes the evaluation and confirmation of the rationality, effectiveness and adequacy of all the actions. Before closing, ensure that all information related to CAPA has been transferred to relevant personnel. After closing, the sterilization supply center should review and summarize regularly.

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    3 Comparison between CAPA and Common Tools

    3.1 CAPA and QCC

    QCC is the abbreviation of Quality Control Circle in this article，it’s a standing group formed spontaneously, which regularly carries out quality promotion activities of preset themes. It emphasizes that all staff participate and work from bottom to top to promote members to effectively solve issues and enjoy their sense of achievement through brainstorming, thus improving their enthusiasm and quality of work. QCC is a people-oriented quality management and pays more attention to attitude, culture and atmosphere [

    4-5]. Due to its long cycle, few urgent issues that have occurred or are occurring can be solved in time by QCC. In contrast, CAPA is more flexible, timely and systematic. It is implemented by a single temporary team composed of unfixed members for a certain event or potential risk trend, the organization and theme are not preset, and are mostly applicable to issues and potential issues or trends after they appear. CAPA can not only take remedial actions in time, but also systematically formulate short- and long-term plans to support a persistent improvement of quality management level.
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    3.2 CAPA and PDCA

    PDCA is a continuous and spiral quality improvement management method[

    6], focusing on continuous improvement. Because the steps are relatively simple, the single cycle can be large or small, and the forms are also diverse. PDCA can be used in almost all things we contact, such as personal self-management and organizational management in various fields. Although it is widely used, it solves more specific issues. Both QCC and CAPA can use PDCA to solve a specific issue in their process. Although CAPA is both a quality management tool, its essence is not to solve issues, but to achieve the purpose of prevention by solving a series of issues and risk factors. Preventive Action is the most and core fundamental. Not only that, CAPA program is more refined and systematic, so CAPA can also be used as a system.
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    4 Discussion

    At the beginning of the 20th century, some countries such as the United States successively implemented total quality management. PDCA is the most widely used management method in many management methods that emerged at the historic moment. QCC is also a quality management activity developed from its extension. The former two have high industrial universality, as a derivative tool under the most rigorous pharmaceutical management, CAPA has complicated procedures, and it is also used in the field of medical devices. As a combination of medical devices and medical services, the sterilization supply center can use the unique three-tier response of CAPA to prevent “minor issues from being excessive and core issues from being ignored”, prevent quality issues from being “treated equally”, and make issues have priority [

    7], thus making measures more effective and quality management more efficient. In particular, after more than 30 years of trials and tribulations, China’s sterilization supply center has stepped into the stage of strengthening refined management[8]. After the initial formation of quality management mode and concept by using general means, the quality management as the core task of sterilization supply should be more specific and refined. CAPA is one of the more targeted and specific methods, which is of great significance for improving the systematization and refinement level of sterilization supply quality.
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    In summary, CAPA is conducive to ensuring the quality safety and operating efficiency of disinfection and sterilization, contributing to the continuous improvement of the quality prevention and management level of sterilization supply, promoting the development process of fine management of the sterilization supply center, and is worthy of further promotion and use.

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    References

    1

    FDA.QSR820.Code of Federal Regulations, CFR 21 PART 820. [Baidu Scholar] 

    2

    ISO 13485:2016,Medical devices—Quality management systems—Requirements for regulatory purposes,8.5:25. [Baidu Scholar] 

    3

    ZHENG S H, LOU L Z. Establishment of corrective and preventive measures (CAPA) system in pharmaceutical enterprises[J]. Chin J Mod Drug Appl, 2011, 5(10): 136. [Baidu Scholar] 

    4

    YIN G H, TAO Y G, CHEN L. The application of quality control circle and deming circle in nursing quality management[J]. Chin J Gen Pract, 2017, 15(2): 352-354. [Baidu Scholar] 

    5

    LUO S H, ZHAO E H, ZHANG X L, et al. Application of quality control circle in quality control of cleaning and disinfection process in sterilization and supply center[J]. Chin J Nosocomiology, 2017, 27(20): 4794-4796, 4800. [Baidu Scholar] 

    6

    WANG D L, SUN A Y, SUN W D. Application of PDCA cycle in medical core system of TCM hospital[J]. Jiangsu Health Syst Manag, 2018, 29(3): 312-314. [Baidu Scholar] 

    7

    Peter Knauer. Corrective and Preventive Action (CAPA) Procedure for Good Manufacturing Practice. Journal of GXP Compliance,2017-10-17. [Baidu Scholar] 

    8

    ZHOU B, LIANG Y Q, GONG Y X. Development process and prospect of Central Sterile Supply Department[J]. Chin Nurs Manag, 2021, 21(10): 1441-1445. [Baidu Scholar] 

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