Glossary / Lexicon

Deutsch: Untersuchung / Español: investigación / Português: investigação / Français: investigation / Italiano: indagine

Investigation in the quality management context refers to the systematic process of identifying, analyzing, and resolving issues that affect the quality of products, services, or processes. This process is critical for determining the root causes of quality problems, implementing corrective actions, and preventing recurrence.

Description

In quality management, an investigation is conducted when a deviation, defect, or non-conformance is detected. The primary objective is to understand the underlying reasons for the issue and to develop effective solutions to address it. Investigations are a key component of continuous improvement and are essential for maintaining high-quality standards.

The investigation process typically involves the following steps:

1. Identification: Recognizing and documenting the quality issue or deviation.
2. Containment: Implementing immediate actions to control and limit the impact of the issue.
3. Root Cause Analysis (RCA): Utilizing systematic methods, such as the 5 Whys, Fishbone Diagram, or Failure Mode and Effects Analysis (FMEA), to determine the fundamental cause of the problem.
4. Corrective Action: Developing and implementing actions to eliminate the root cause and prevent recurrence.
5. Verification: Ensuring that the corrective actions effectively resolve the issue and that the problem does not reoccur.
6. Documentation: Recording all findings, actions taken, and outcomes to provide a comprehensive account of the investigation process.

Application Areas

1. Manufacturing: Investigating production defects, equipment malfunctions, or process deviations to improve product quality and operational efficiency.
2. Healthcare: Analyzing adverse events, medication errors, or procedural deviations to enhance patient safety and care quality.
3. Pharmaceuticals: Examining deviations in drug production, contamination events, or non-compliance with regulatory standards.
4. Food and Beverage: Investigating food safety incidents, contamination cases, or quality control failures to ensure product safety and compliance.
5. Service Industries: Addressing customer complaints, service delivery failures, or process inefficiencies to improve customer satisfaction and service quality.
6. Construction: Analyzing structural defects, safety incidents, or project deviations to ensure compliance with standards and project specifications.

Well-Known Examples

• Toyota Production System (TPS): Known for its robust problem-solving approach, including the use of Root Cause Analysis to investigate and address production issues.
• FDA Inspections: Regulatory investigations conducted by the Food and Drug Administration to ensure compliance with pharmaceutical and food safety standards.
• Six Sigma Projects: Utilizes DMAIC (Define, Measure, Analyze, Improve, Control) methodology to systematically investigate and resolve quality issues.
• CAPA (Corrective and Preventive Action): A process used in various industries, particularly pharmaceuticals and medical devices, to investigate and address quality issues and prevent future occurrences.

Treatment and Risks

Effective investigation in quality management involves several strategies and awareness of potential risks:

• Structured Methodology: Employing systematic investigation methods to ensure thorough analysis and accurate identification of root causes.
• Cross-Functional Teams: Involving experts from different departments to provide diverse perspectives and expertise in the investigation process.
• Training and Education: Ensuring that personnel are trained in investigation techniques and root cause analysis methods.
• Documentation and Communication: Maintaining comprehensive records of the investigation process and communicating findings and actions to all relevant stakeholders.

Risks associated with investigations include:

• Incomplete Analysis: Failing to identify the true root cause can lead to ineffective corrective actions and recurrence of the issue.
• Bias and Assumptions: Allowing personal biases or incorrect assumptions to influence the investigation can compromise the accuracy of findings.
• Resource Constraints: Limited time, personnel, or financial resources can hinder the thoroughness of the investigation.
• Resistance to Change: Employees may resist implementing corrective actions, especially if they perceive changes as disruptive or unnecessary.

Similar Terms

• Root Cause Analysis (RCA): A systematic method used to identify the underlying reasons for a problem or defect.
• Corrective and Preventive Action (CAPA): A process that includes investigation, corrective action, and preventive action to address quality issues and prevent recurrence.
• Non-Conformance Report (NCR): A document that details deviations from expected standards and initiates an investigation process.
• Audit: A systematic examination of processes, products, or systems to ensure compliance with standards and identify areas for improvement.
• Deviation Investigation: Analyzing deviations from standard procedures or specifications to determine causes and corrective actions.

Weblinks

• allerwelt-lexikon.de: 'Untersuchung' in the allerwelt-lexikon.de (German)
• top500.de: 'Investigation' in the glossary of the top500.de
• psychology-lexicon.com: 'Investigation' in the psychology-lexicon.com
• umweltdatenbank.de: 'Untersuchung' im Lexikon der umweltdatenbank.de (German)

Summary

Investigation in the quality management context is a vital process for identifying, analyzing, and resolving quality issues. By systematically investigating deviations, defects, or non-conformances, organizations can determine root causes, implement effective corrective actions, and prevent recurrence. This process is crucial for maintaining high-quality standards, ensuring compliance, and fostering continuous improvement. Effective investigations involve structured methodologies, cross-functional collaboration, and thorough documentation to ensure accurate and actionable outcomes.

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