Questions and Answers
What is the primary purpose of including supporting information and evidence in the notes of the activity record?
Who is responsible for conducting the assessment to determine the effectiveness of the improvement actions?
What is the purpose of the 'In Progress' stage of the improvement activity?
What happens when the improvement need has been fully investigated and actions have been implemented and verified?
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Who is responsible for notifying improvement team members and management stakeholders when the improvement need is closed?
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Where are records relevant to the internal improvement program stored?
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What is the primary goal of the improvement activities at CDC?
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Which methodology is NOT mentioned as part of CDC's improvement activities?
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What status code indicates that an improvement need has been identified and a record has been initiated?
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What action is triggered when progress on improvement activities has stalled?
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What is the role of the Quality Assurance department in the improvement action process?
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What is the primary role of the responsible person in the improvement activity?
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What is the minimum timeframe required to complete an improvement activity?
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What is the purpose of verifying actions in the improvement activity?
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What is the purpose of the effectiveness assessment in the improvement activity?
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Which of the following is an example of objective evidence used in verification?
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Who is responsible for verifying the implementation of improvement actions?
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What is the main difference between corrective action and preventative action in the improvement methodologies?
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Which of the following best describes an Improvement Area within CDC's improvement methodologies?
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Which statement accurately reflects the purpose of an Initiative in the context of CDC's improvement methodologies?
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When might a nonconformance be identified in the organization?
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What is the primary focus of the Corrective Action methodology within CDC's improvement efforts?
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Study Notes
Improvement Program at Continental Disc Corporation (CDC)
- CDC engages in activities to identify, analyze, and improve constraints and challenges within the organization, correcting and preventing nonconformances and meeting future needs and expectations.
Improvement Action Types
- CDC uses various methodologies to improve constraints and challenges, including correcting reported nonconformances.
- Nonconformances occur when a process, service, or product does not meet stated requirements and can be identified through customer complaints, audit reports, inspection records, and KPIs.
Improvement Action Process
- All improvement activities are recorded in the current ERP system with a unique identification number.
- Improvement action status is monitored for progression and timely completion by Quality Assurance.
Improvement Action Status Codes
- Created: An improvement need is identified, and a record is initiated in the ERP system with a concise description and supporting information.
- Released: A responsible person is identified, and a target completion date is determined for the improvement activity.
- In Progress: Team members are selected, and work is performed to complete the improvement activity, including assessing effectiveness.
- Closed: The improvement need is fully investigated, and actions are implemented, verified, and determined to be effective.
- Cancelled: The improvement record is released but later withdrawn, with justification for cancellation detailed in the record.
Record Retention
- All records relevant to CDC's internal improvement program are retained and managed in accordance with QCI-1028, Quality Records, and stored electronically in the current ERP system.
Revision Control
- Revision control is maintained, with a record of revisions, descriptions, dates, and approvals.
Improvement Activity Status
- Released:
- A responsible person is identified to manage the improvement activity
- A target completion date is set, minimum 60 days from initiation
- The responsible person ensures the improvement team addresses the issue effectively and completes actions on time
In Progress: Improvement Activity Steps
- Investigate:
- Identify why the issue occurred, including human factors
- Review all possible causes using techniques like 5-Whys, Fishbone Diagrams, and Pareto Principles
- Determine the root cause of the issue
- Actions:
- Brainstorm and generate multiple possible solutions
- Evaluate each solution based on feasibility, effectiveness, cost, risk, and impact
- Implement permanent measures to address or remove the identified root causes
- Verification:
- Responsible person confirms actions are implemented and effective through objective evidence
- Examples of objective evidence include procedure changes, training records, process observations, and internal audits
- Effectiveness:
- Quality Assurance assesses the implementation of improvement actions
- Determines if actions have sustained, addressed the root cause, and prevented recurrence of the issue
- Evidence of effectiveness may include employee interviews, process observations, internal and external nonconformance records, data analysis, and current KPIs
Improvement Action Types
- CDC continuously identifies, analyzes, and improves constraints and challenges within the organization to correct reported nonconformances.
- Nonconformance occurs when a process, service, or product fails to meet stated requirements, and can be identified through:
- Customer complaints
- Audit reports
- Inspection records
- KPIs
- CDC uses four improvement methodologies:
Corrective Action
- Reactive measure to eliminate causes of nonconformities and prevent recurrence.
Preventative Action
- Proactive measure to eliminate causes of potential nonconformities or undesirable situations.
Improvement Area
- Enhancements leading to better:
- Efficiency
- Effectiveness
- Compliance in a process or system
Initiative
- Strategies to identify and resolve issues in a process or workflow to:
- Increase efficiency
- Improve productivity
- Achieve compliance
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Description
This quiz covers the process of implementing and maintaining an effective improvement program to enhance customer satisfaction and improve the Quality Management System (QMS).
