QSE 9 — Process Improvement

Key Concepts

Key Concepts: This QSE focuses on the use of corrective and preventive actions to drive process improvement. It describes measures to ensure that the root causes of nonconformances are effectively addressed.

Key Terms
Adverse Event: A complication. Adverse events may occur in relation to organization-defined activities.

Assessment: A systematic examination to determine whether actual activities comply with planned activities, are implemented effectively, and achieve objectives. Types of assessments include external assessments, internal assessments, peer review, and self-assessments.

Corrective Action: Actions taken to address the root cause(s) of an existing nonconformance or other undesirable situation in order to reduce or eliminate recurrence.

Deviation: A departure from policies, processes, procedures, applicable regulations, standards, or specifications.

Near-Miss Event: An unexpected occurrence that did not adversely affect the outcome but could have resulted in a serious adverse event.

Nonconformance: Failure to meet requirements.

Preventive Action: An action taken to reduce or eliminate the potential for unexpected deviations, nonconformances, or other undesirable situations.

Root Cause(s): The underlying cause(s) of an event or nonconformance that, if eliminated, would prevent recurrence.

Examples of Objective Evidence:

• Policies, processes, and procedures related to this chapter.
• Records of collected data analysis and corrective action taken when near-misses, deviations, or adverse events are discovered.
• Tracking of relevant data that affect the organization’s current and future operations.
• Records indicating that corrective and preventive action was taken.
• Records indicating that corrective and preventive action taken was effective and is being monitored.
• Documentation that process improvement data are included in executive management review.

9.0 Process Improvement

[Cord blood applicable]

The organization shall collect data, perform analysis, and follow up on issues requiring corrective and preventive action, including near-miss events.

Guidance

This chapter requires the facility to identify corrective and preventive action that might be required in the program, to collect data about these actions, to analyze the necessary action, and to follow up on any corrective or preventive actions.

This standard requires that there be a process to manage corrective and preventive action. Corrective action, at a minimum, must include: effective handling of error and accident reports that relate to nonconformances; investigation of the cause of the nonconformance; records of the investigation; a determination of the corrective action needed to eliminate the nonconformance; and evaluation to ensure that corrective action is taken and that it is effective.

Preventive action must include the review of appropriate sources of information to detect and analyze potential causes of nonconformances. Internal and external assessment results, customer complaints, quality control records, and proficiency testing results are potential sources of information.

The goal of Chapter 7, Deviations, Nonconformances, and Adverse Events, is to control nonconforming products or materials to prevent their unintended administration. Chapter 9 requires a facility to have processes and procedures for implementing corrective and preventive action plans to prevent nonconformances from recurring. Periodic management review of these plans and their implementation is also required to ensure continued effectiveness.

Although most organizations deal well with immediate problems, a thorough investigation of the cause for each occurrence is important to identify contributing factors and potential opportunities for process improvement. Quality improvement tools such as root cause analysis or failure mode effects analysis may need to be initiated for nonconformances and near-miss events. This critical step is an important aspect of a quality system. Efforts dedicated to corrective and preventive actions should be proportional to the magnitude of the problem or potential problem so that resources (ie, time) can be appropriately allocated. The standards do not specifically define the nature, extent, or scope of appropriate corrective or preventive actions; the program will determine these actions. (SS)

The committee revised standard 9.0 based on updates to the AABB Quality System Essentials. (SC)

☑ Actionable Checklist

• Develop and implement a CAPA SOP that includes procedures for identifying, documenting, and analyzing nonconformances and near-miss events.
  • Include steps for root cause analysis and failure mode effects analysis.
• Establish a process for collecting and reviewing data from internal audits, customer complaints, and quality control records.
• Maintain a CAPA log to document all corrective and preventive actions, including investigation results and effectiveness evaluations.
• Schedule regular management reviews to assess the effectiveness of CAPA plans and make necessary adjustments.
• Train staff on CAPA procedures and document all training sessions and competency evaluations.
• Conduct periodic reviews of CAPA processes to identify opportunities for process improvement and resource allocation.

9.1 Corrective Action

[F]

The organization shall have a process for corrective action that includes:

1. Description of the event.
2. Investigation of the root cause(s) of nonconformances relating to the product or service, the process, and the quality system.
3. Determination of the corrective action needed to eliminate the cause of nonconformances, as applicable.
4. Ensuring that corrective action is reviewed and found to be effective.

Guidance

Corrective action is taken in response to identified problems. Corrective action processes and procedures should include:

• Description of the event to help best determine the cause and identify any potential corrective action.
• Effective handling of nonconformance reports to aid in the description of the event.
• Investigation of the cause of product or service nonconformances.
• Review of current processes and procedures and determination if any corrective action is necessary.
• Initiation of corrective action(s) and verification that they were effective. (SS)

​#1 - The committee added subnumber 1 to standard 9.1 based on updates to the AABB Quality System Essentials.  (SC)

☑ Actionable Checklist

• Develop and maintain an SOP for documenting and describing events leading to nonconformances.
  • Include a template for event description in the SOP.
• Implement a root cause analysis procedure for investigating nonconformances.
  • Use tools like fishbone diagrams or 5 Whys for root cause analysis.
• Establish a corrective action plan template to determine necessary actions to eliminate nonconformances.
• Conduct effectiveness reviews of corrective actions within a specified timeframe.
  • Document findings in a corrective action effectiveness log.
• Train staff on the corrective action process and document training records.
• Schedule regular management reviews to assess the effectiveness of corrective actions and update procedures as needed.

9.1.1

Investigation and corrective action shall include consideration of deviations, nonconformances, and complaints. Chapter 7, Deviations, Nonconformances, and Adverse Events, applies.

Guidance

The committee revised standard 9.1.1 based on updates to the AABB Quality System Essentials, which includes some verbiage from standard 9.1 in the previous edition. (SC)

☑ Actionable Checklist

• Develop and maintain an SOP for investigating deviations, nonconformances, and complaints.
  • Include criteria for identifying and categorizing issues.
  • Outline steps for root cause analysis and documentation.
• Implement a tracking system for logging all deviations, nonconformances, and complaints.
  • Ensure the system allows for trend analysis and reporting.
• Establish a CAPA process to address identified issues.
  • Define timelines for corrective and preventive actions.
  • Assign responsibility for each action item.
• Conduct regular reviews of deviation and nonconformance logs.
  • Include these reviews in management meetings.
  • Document outcomes and any additional actions required.
• Train staff on the process for reporting and managing deviations and nonconformances.
  • Maintain records of training sessions and competency evaluations.
• Perform internal audits to ensure compliance with the SOP and effectiveness of corrective actions.

9.2 Preventive Action

[F]

The organization shall have a process for preventive action
that includes:

1. Analysis of appropriate sources of information to detect, analyze, and eliminate potential causes of nonconformances.
2. Determination of steps needed to address any problems requiring preventive action.
3. Initiation of preventive action and application of controls to ensure that it is effective.
4. Risk assessment and mitigation strategies at defined intervals.

Standard 1.4 applies.

Guidance

Preventive action is active planning for potential problems. Preventive action processes and procedures should include:

• Use of appropriate information to identify potential problems.
• Review of current processes and procedures and identification and determination of steps necessary to prevent potential problems, and initiation of preventive action.
• Periodic follow-up with review of risk assessment to confirm effectiveness and adapt processes, if needed, will ensure a proactive approach to preventive action.

Examples of information that may be used to improve processes include: assessment results, quality records, or customer complaints. (SS)

#1 - The committee revised standard 9.2, #1 based on updates to the AABB Quality System Essentials. (SC)

#4 - The committee added new subnumber 4 to standard 9.2 for completeness. (SC)

☑ Actionable Checklist

• Develop and implement an SOP for preventive action processes, including analysis of information sources.
  • Include procedures for detecting, analyzing, and eliminating potential causes of nonconformances.
• Identify and document appropriate sources of information for preventive action, such as assessment results, quality records, and customer complaints.
• Establish a procedure for determining steps needed to address problems requiring preventive action.
  • Include criteria for initiating preventive action and applying controls to ensure effectiveness.
• Conduct regular risk assessments and document mitigation strategies at defined intervals.
  • Review and update risk assessments based on new information or changes in processes.
• Schedule periodic follow-ups to review the effectiveness of preventive actions and adapt processes as needed.
• Maintain records of all preventive actions, including analysis, steps taken, and follow-up results, in a designated log or database.

9.3 Performance Improvement

The organization shall track and identify trends in information related to its operational and quality system performance to identify opportunities for improvement.

☑ Actionable Checklist

• Develop and implement a system for tracking key performance indicators (KPIs) related to operational and quality system performance.
  • Use a standardized form or software to log and analyze KPI data monthly.
• Conduct regular trend analysis meetings to review KPI data and identify areas for improvement.
  • Document meeting minutes and action items in a designated log.
• Establish a process for documenting identified opportunities for improvement and assigning responsibility for action.
  • Use a standardized form to record improvement opportunities and track progress.
• Integrate performance improvement findings into the management review process.
  • Ensure that management review agendas include a section for discussing performance trends and improvement opportunities.
• Update relevant SOPs to reflect changes made as a result of performance improvement activities.
• Train staff on new procedures or changes resulting from performance improvement initiatives and document training completion.

9.3.1

Management shall review relevant information on corrective or preventive actions taken. Any corrective or preventive actions taken to eliminate the causes of actual or potential nonconformances shall be proportional to the magnitude of problems and the risks encountered.

Guidance

Preventive actions may be in response to minor observations, but in combination and over time, the
facility may discover trends that depict system-wide problems. Although preventive action is intended to avoid potential problems, it can also be a process improvement tool to assist the facility in operating more effectively and efficiently. (SS)

Excerpt of Reference Standard 6.2.9A Relevant to Process Improvement

Standard	Record to Be Maintained	Quality System Records	Donor Eligibility/Management Issues	Unit/Recipient	Retention after Creation (C) or Final Disposition (F) of Related Product	Minimum Retention Time (in years)1
9.0	Implementation of changes to policies, processes, and procedures resulting from corrective and preventive action	X	X	X	C	10
9.1	Corrective action	X	X	X	F	10
9.2	Preventive action	X	X	X	F	10

¹Applicable federal, state, or local law may exceed this period.

☑ Actionable Checklist

• Conduct regular management reviews of corrective and preventive actions (CAPAs) to assess effectiveness and proportionality to the magnitude of issues.
  • Document the outcomes of these reviews in a management review log.
• Implement a system to track and trend minor observations to identify potential system-wide issues.
  • Use a preventive action tracking form to document identified trends and actions taken.
• Ensure all changes to policies, processes, and procedures resulting from CAPAs are documented and retained for a minimum of 10 years.
  • Maintain a change implementation log for tracking these updates.
• Conduct periodic internal audits to verify compliance with CAPA processes and identify areas for improvement.
  • Document audit findings and follow-up actions in an audit report.
• Maintain a CAPA log that includes all corrective and preventive actions, with details on implementation and review dates.
• Ensure all staff involved in CAPA processes are trained and competency evaluations are documented and current.