The document discusses the differences between corrective and preventive action as defined in ISO 9000 standards. It notes that corrective action addresses nonconformities that have already occurred to prevent recurrence, while preventive action aims to eliminate potential causes of nonconformities that have not yet occurred. The document provides examples of situations that would constitute patches, corrective actions, preventive actions, and developmental actions. It aims to dispel common misconceptions, such as treating all actions the same or considering major process changes as only corrective actions.
The document provides guidance on conducting a root cause analysis and corrective action process for nonconformances identified in Nadcap audits. It outlines a 6-step process: 1) taking immediate containment actions, 2) defining the problem, 3) analyzing the causes, 4) determining the solution, 5) assessing if the solution is acceptable, and 6) reporting. The process is described as one approach that can be used to meet Nadcap's requirements of identifying immediate corrective actions, root causes, impacts, actions to prevent recurrence, and objective evidence.
A Risk-Based Approach for Investigating Environmental Monitoring ExcursionsRobert Westney
This document outlines a risk-based approach for investigating environmental monitoring excursions. It discusses elements of an investigation plan, key investigation points, root cause analysis, corrective actions, and assessing the impact on facilities and products. A risk-based approach considers the probability and severity of harm to determine appropriate corrective actions. Investigations should identify root causes and prevent recurrence by modifying procedures, training, or equipment. The potential impact on facilities and products is assessed based on historical data trends and control of manufacturing processes.
This document discusses implementing an Occupational Health and Safety Management System (OHSMS) for geotechnical risks associated with mine fill operations. It recommends conducting audits of the mine fill system design, technical specifications, underground monitoring and documentation to ensure all components are addressed holistically. Specifically, it suggests auditing areas like risk registers, resources, documented systems of work, incident investigations, emergency preparedness, and trigger action plans based on OHSMS standards. The goal is to achieve OHSMS compliance certification for technical risks to demonstrate due diligence and duty of care through a process of audits, risk assessments by multi-disciplinary teams, identifying gaps, and continuous improvement.
RCA on Residual defects – Techniques for adaptive Regression testingIndium Software
One of the important issues associated with a system lifespan view that we have ignored in past
years is the effects of enduring defects – defects that persist undetected – across several
releases of a system. Many studies performed to date have evaluated regression testing
techniques under the limited context such as short term assessment which do not fully account
for the industry based solutions.
Reports estimate that regression testing consumes as much as 80% of the overall testing
budget and can consume up to 50% of the cost of software maintenance.
The document provides a roadmap for optimizing sterile processing workflows through a seven step process: 1) Mapping workflows; 2) Improving functions and workflow by streamlining, identifying waste, simplifying work processes, and balancing capacity; 3) Optimizing workstation layout and operations sequence; 4) Standardizing work practices; 5) Scheduling processes; 6) Measuring performance; and 7) Active management and supervision. The goal is to produce quality instrument sets efficiently to meet surgical demand with existing resources.
Managing A Successful Team Offline VersionDrPaulHancock
A recent presentation given, highlighting two opposing management techniques {McGregors X-Y styles} with context given ranging from the father of modern economics, Adam Smith, to the highly respected Statistician William Deming. The general approach taken seems a simplification, with perhaps a hybrid model suiting some systems, therefore due to concision , caveats are attached. The presentation is an offline version as it links into local mind mapping software, so some visuals are included as thumbnail examples of RCA tools and mind-maps drawn up from my experience working in the pharmaceutical inhalation devices industry and literature sources .
An assessment of a software testing organization can identify strengths, weaknesses, and improvement opportunities by comparing it to industry benchmarks. It provides a roadmap for reducing costs and improving quality. SDT offers assessments to evaluate metrics, methods, tools, practices, and environment used for testing. An assessment identifies high priority areas for enhancing effectiveness and efficiency based on best practices.
World-Class Incident Response ManagementKeith Smith
Taken from principles learned over many years at several companies including Microsoft, this presentation describes the process of creating a strongly defined and repeatable Incident Response Management pipeline. The goal of this presentation is to increase companies ability to maintain healthy cloud services throughout the entire application lifecycle. It describes how companies should identify, respond to, and manage incidents, on-call procedures, and organizational implementations that reduce incident fatigue and keep services consistently reliable and available.
The document provides guidance on conducting a root cause analysis and corrective action process for nonconformances identified in Nadcap audits. It outlines a 6-step process: 1) taking immediate containment actions, 2) defining the problem, 3) analyzing the causes, 4) determining the solution, 5) assessing if the solution is acceptable, and 6) reporting. The process is described as one approach that can be used to meet Nadcap's requirements of identifying immediate corrective actions, root causes, impacts, actions to prevent recurrence, and objective evidence.
A Risk-Based Approach for Investigating Environmental Monitoring ExcursionsRobert Westney
This document outlines a risk-based approach for investigating environmental monitoring excursions. It discusses elements of an investigation plan, key investigation points, root cause analysis, corrective actions, and assessing the impact on facilities and products. A risk-based approach considers the probability and severity of harm to determine appropriate corrective actions. Investigations should identify root causes and prevent recurrence by modifying procedures, training, or equipment. The potential impact on facilities and products is assessed based on historical data trends and control of manufacturing processes.
This document discusses implementing an Occupational Health and Safety Management System (OHSMS) for geotechnical risks associated with mine fill operations. It recommends conducting audits of the mine fill system design, technical specifications, underground monitoring and documentation to ensure all components are addressed holistically. Specifically, it suggests auditing areas like risk registers, resources, documented systems of work, incident investigations, emergency preparedness, and trigger action plans based on OHSMS standards. The goal is to achieve OHSMS compliance certification for technical risks to demonstrate due diligence and duty of care through a process of audits, risk assessments by multi-disciplinary teams, identifying gaps, and continuous improvement.
RCA on Residual defects – Techniques for adaptive Regression testingIndium Software
One of the important issues associated with a system lifespan view that we have ignored in past
years is the effects of enduring defects – defects that persist undetected – across several
releases of a system. Many studies performed to date have evaluated regression testing
techniques under the limited context such as short term assessment which do not fully account
for the industry based solutions.
Reports estimate that regression testing consumes as much as 80% of the overall testing
budget and can consume up to 50% of the cost of software maintenance.
The document provides a roadmap for optimizing sterile processing workflows through a seven step process: 1) Mapping workflows; 2) Improving functions and workflow by streamlining, identifying waste, simplifying work processes, and balancing capacity; 3) Optimizing workstation layout and operations sequence; 4) Standardizing work practices; 5) Scheduling processes; 6) Measuring performance; and 7) Active management and supervision. The goal is to produce quality instrument sets efficiently to meet surgical demand with existing resources.
Managing A Successful Team Offline VersionDrPaulHancock
A recent presentation given, highlighting two opposing management techniques {McGregors X-Y styles} with context given ranging from the father of modern economics, Adam Smith, to the highly respected Statistician William Deming. The general approach taken seems a simplification, with perhaps a hybrid model suiting some systems, therefore due to concision , caveats are attached. The presentation is an offline version as it links into local mind mapping software, so some visuals are included as thumbnail examples of RCA tools and mind-maps drawn up from my experience working in the pharmaceutical inhalation devices industry and literature sources .
An assessment of a software testing organization can identify strengths, weaknesses, and improvement opportunities by comparing it to industry benchmarks. It provides a roadmap for reducing costs and improving quality. SDT offers assessments to evaluate metrics, methods, tools, practices, and environment used for testing. An assessment identifies high priority areas for enhancing effectiveness and efficiency based on best practices.
World-Class Incident Response ManagementKeith Smith
Taken from principles learned over many years at several companies including Microsoft, this presentation describes the process of creating a strongly defined and repeatable Incident Response Management pipeline. The goal of this presentation is to increase companies ability to maintain healthy cloud services throughout the entire application lifecycle. It describes how companies should identify, respond to, and manage incidents, on-call procedures, and organizational implementations that reduce incident fatigue and keep services consistently reliable and available.
The document discusses closed-loop corrective action (CLCA), which is a process for identifying problems, determining their root causes, developing and implementing solutions to prevent recurrence, and verifying the effectiveness of the solutions. It covers determining the cause of issues, deciding if and what type of corrective action is needed, implementing and tracking corrective actions, handling customer complaints, and ensuring the actions address the root causes. Software tools are available to help facilitate tracking the CLCA process.
This document provides a standard operating procedure for managing validation exceptions at a pharmaceutical company. It outlines responsibilities for identifying, documenting, investigating, approving, and closing exceptions. The procedure involves documenting exceptions in a non-conformance template, evaluating their criticality, developing corrective or preventive actions, and obtaining approval from relevant parties. The goal is to properly handle exceptions to provide continuous quality improvement and ensure validation studies and systems meet requirements before release.
The document discusses Corrective and Preventive Action Plans (CAPA) used to improve organizations and address issues found through failure rates, customer complaints, and supplier definitions. CAPA helps find core issues and actions for improvement programs. Root cause analysis is used to identify the underlying cause of problems in order to implement targeted action plans. Effective CAPA systems include escalation processes, separate phases for investigation and action planning, and trend analysis to identify common issues requiring preventative improvement initiatives. Documentation of CAPA plans should include a root cause analysis, identification of corrective/preventative actions, verification of actions, implementation, and effectiveness checks.
Effective CAPA Implementation in a Management System - Praneet SurtiPraneet Surti
The document discusses the Corrective Action and Preventive Action (CAPA) process. It defines CAPA as a structured way to investigate non-conformities, determine appropriate corrections and actions, and measure their effectiveness. It outlines the key steps in the CAPA process including defining the problem, investigating the root cause, determining corrective and preventive actions, implementing solutions, and measuring effectiveness. The document emphasizes that the goal of CAPA is to eliminate causes of issues in order to prevent recurrence and notes that a mature CAPA system can help continuously improve products, services, and compliance.
Closed-loop corrective action (CLCA) is a process that traces problems to their root causes, develops solutions to prevent recurrence, implements changes, and monitors effectiveness. It involves determining the cause of nonconformities, deciding if corrective action is needed, identifying the appropriate action, implementing it, handling complaints, and ensuring the action addressed the problem. CLCA aims to fix processes by eliminating underlying causes rather than just addressing symptoms.
Sop 820 capa procedure corrective preventive action med devConnie Dello Buono
This document outlines the corrective and preventive action (CAPA) procedure for addressing non-conformances and quality problems. It defines when a CAPA should be initiated, such as for systemic or repetitive issues. It describes assigning a CAPA owner to investigate the root cause and identify corrective actions. Effectiveness of these actions must be verified through follow-up audits. Preventive actions may also be initiated through trend analysis to address potential problems. All CAPAs require management review and sign-off for implementation and closure within 4 months. The CAPA coordinator communicates results and actions to management.
Corrective and Preventive Action (CAPA) systems are important tools for addressing issues and preventing recurrences. However, CAPAs require careful planning and execution to be effective. Common pitfalls include opening CAPAs without stakeholder buy-in, failing to thoroughly investigate root causes, and establishing unrealistic timelines. Keys to success are gaining management support, using root cause analysis tools, defining specific action items, conducting effectiveness checks, and maintaining thorough documentation. The FDA scrutinizes CAPA systems and may issue observations for deficiencies.
This presentation outlines the CBDI-SAE SOA Exception Management Framework that provides a structured approach to specifying exception conditions and dealing with them at run-time. It primarily considers exception management within Service-based solutions.
This document provides an overview of corrective and preventive actions (CAPA) as part of a quality management system. It defines CAPA and explains that it aims to eliminate causes of nonconformities and prevent their recurrence. The document outlines the CAPA process, which involves nonconformance identification, root cause analysis, corrective action planning, implementation, and follow-up to verify effectiveness. It emphasizes that CAPA is important for continuous quality improvement.
Blueprint for success process reinvention case studyJoan Davis
This document summarizes a case study where a consulting firm helped an organization reinvent its processes to meet new regulatory requirements within 3 months. They conducted interviews and workshops to understand how the new directive would impact goals, stakeholders, and processes. They analyzed current and required processes, systems, and architecture. They delivered documentation of their analysis and recommendations, which helped the organization with regulatory presentations, staff training, technical planning, and continuous improvement. The consulting firm was able to comprehensively analyze the enterprise-wide changes and transition plan through a collaborative workshop approach within the constrained timeline.
This document provides an introduction to quality and quality control concepts. It discusses that quality is fitness for use and conformance to requirements, with multiple quality characteristics including structural, sensory, time-oriented, commercial, and ethical elements. Control and quality control involve observing performance, comparing to standards, and taking action on differences. Quality control aims to measure quality, compare to standards, and act on differences. Design reviews, failure mode analysis, reliability programs, statistical process control, and corrective action systems are discussed as key aspects of ensuring quality.
This document discusses deviation handling and root cause analysis. It defines deviations as departures from standard procedures and outlines regulatory expectations to investigate deviations and prevent reoccurrence. The basic process flow for handling deviations includes identification, assessment, classification, investigation and corrective actions. Root cause analysis is presented as a method to systematically identify underlying causes of problems using techniques like brainstorming, 5 whys, and cause-and-effect diagrams. The goals of root cause analysis are failure identification, analysis, and resolution through an iterative process.
In Industry there are lots failures related to the routine process, Equipment and System by one or other means.
So one must analyze control such failures in manner that it will not affect your ultimate output and obviously that is your Product and its Quality.
The document discusses implementing a holistic quality management system (QMS) by redefining corrective and preventive action (CAPA). It outlines challenges with traditional QMS approaches and regulations from ISO, FDA, and the European Commission regarding CAPA. The document recommends treating any opportunity to improve quality as a CAPA, and that CAPAs should follow a process from identifying problems to verifying the effectiveness of corrective actions.
Reliability Centered Maintenance (RCM) is a process that determines the best policies for managing asset functions and failures. It considers all asset management options like condition monitoring, scheduled restoration, and scheduled discard. RCM provides the optimal mix of reactive, time-based, condition-based, and proactive maintenance practices. When applied to commercial airlines in the 1970s, RCM reduced equipment-related crashes from 40 to 0.3 per million take-offs.
This document outlines a seven step process for Corrective and Preventive Action (CAPA) programs: 1) Identification, 2) Evaluation, 3) Investigation, 4) Analysis, 5) Action Plan, 6) Implementation, and 7) Follow-Up. It defines corrective and preventive actions and provides examples. A comprehensive CAPA process identifies problems, determines the root cause, develops a plan to fix the problem and prevent recurrence, implements the plan, and ensures effectiveness. The seven steps provide a framework to systematically address issues in a way that satisfies regulatory requirements and drives continuous improvement.
The document discusses closed-loop corrective action (CLCA), which is a process for identifying problems, determining their root causes, developing and implementing solutions to prevent recurrence, and verifying the effectiveness of the solutions. It covers determining the cause of issues, deciding if and what type of corrective action is needed, implementing and tracking corrective actions, handling customer complaints, and ensuring the actions address the root causes. Software tools are available to help facilitate tracking the CLCA process.
This document provides a standard operating procedure for managing validation exceptions at a pharmaceutical company. It outlines responsibilities for identifying, documenting, investigating, approving, and closing exceptions. The procedure involves documenting exceptions in a non-conformance template, evaluating their criticality, developing corrective or preventive actions, and obtaining approval from relevant parties. The goal is to properly handle exceptions to provide continuous quality improvement and ensure validation studies and systems meet requirements before release.
The document discusses Corrective and Preventive Action Plans (CAPA) used to improve organizations and address issues found through failure rates, customer complaints, and supplier definitions. CAPA helps find core issues and actions for improvement programs. Root cause analysis is used to identify the underlying cause of problems in order to implement targeted action plans. Effective CAPA systems include escalation processes, separate phases for investigation and action planning, and trend analysis to identify common issues requiring preventative improvement initiatives. Documentation of CAPA plans should include a root cause analysis, identification of corrective/preventative actions, verification of actions, implementation, and effectiveness checks.
Effective CAPA Implementation in a Management System - Praneet SurtiPraneet Surti
The document discusses the Corrective Action and Preventive Action (CAPA) process. It defines CAPA as a structured way to investigate non-conformities, determine appropriate corrections and actions, and measure their effectiveness. It outlines the key steps in the CAPA process including defining the problem, investigating the root cause, determining corrective and preventive actions, implementing solutions, and measuring effectiveness. The document emphasizes that the goal of CAPA is to eliminate causes of issues in order to prevent recurrence and notes that a mature CAPA system can help continuously improve products, services, and compliance.
Closed-loop corrective action (CLCA) is a process that traces problems to their root causes, develops solutions to prevent recurrence, implements changes, and monitors effectiveness. It involves determining the cause of nonconformities, deciding if corrective action is needed, identifying the appropriate action, implementing it, handling complaints, and ensuring the action addressed the problem. CLCA aims to fix processes by eliminating underlying causes rather than just addressing symptoms.
Sop 820 capa procedure corrective preventive action med devConnie Dello Buono
This document outlines the corrective and preventive action (CAPA) procedure for addressing non-conformances and quality problems. It defines when a CAPA should be initiated, such as for systemic or repetitive issues. It describes assigning a CAPA owner to investigate the root cause and identify corrective actions. Effectiveness of these actions must be verified through follow-up audits. Preventive actions may also be initiated through trend analysis to address potential problems. All CAPAs require management review and sign-off for implementation and closure within 4 months. The CAPA coordinator communicates results and actions to management.
Corrective and Preventive Action (CAPA) systems are important tools for addressing issues and preventing recurrences. However, CAPAs require careful planning and execution to be effective. Common pitfalls include opening CAPAs without stakeholder buy-in, failing to thoroughly investigate root causes, and establishing unrealistic timelines. Keys to success are gaining management support, using root cause analysis tools, defining specific action items, conducting effectiveness checks, and maintaining thorough documentation. The FDA scrutinizes CAPA systems and may issue observations for deficiencies.
This presentation outlines the CBDI-SAE SOA Exception Management Framework that provides a structured approach to specifying exception conditions and dealing with them at run-time. It primarily considers exception management within Service-based solutions.
This document provides an overview of corrective and preventive actions (CAPA) as part of a quality management system. It defines CAPA and explains that it aims to eliminate causes of nonconformities and prevent their recurrence. The document outlines the CAPA process, which involves nonconformance identification, root cause analysis, corrective action planning, implementation, and follow-up to verify effectiveness. It emphasizes that CAPA is important for continuous quality improvement.
Blueprint for success process reinvention case studyJoan Davis
This document summarizes a case study where a consulting firm helped an organization reinvent its processes to meet new regulatory requirements within 3 months. They conducted interviews and workshops to understand how the new directive would impact goals, stakeholders, and processes. They analyzed current and required processes, systems, and architecture. They delivered documentation of their analysis and recommendations, which helped the organization with regulatory presentations, staff training, technical planning, and continuous improvement. The consulting firm was able to comprehensively analyze the enterprise-wide changes and transition plan through a collaborative workshop approach within the constrained timeline.
This document provides an introduction to quality and quality control concepts. It discusses that quality is fitness for use and conformance to requirements, with multiple quality characteristics including structural, sensory, time-oriented, commercial, and ethical elements. Control and quality control involve observing performance, comparing to standards, and taking action on differences. Quality control aims to measure quality, compare to standards, and act on differences. Design reviews, failure mode analysis, reliability programs, statistical process control, and corrective action systems are discussed as key aspects of ensuring quality.
This document discusses deviation handling and root cause analysis. It defines deviations as departures from standard procedures and outlines regulatory expectations to investigate deviations and prevent reoccurrence. The basic process flow for handling deviations includes identification, assessment, classification, investigation and corrective actions. Root cause analysis is presented as a method to systematically identify underlying causes of problems using techniques like brainstorming, 5 whys, and cause-and-effect diagrams. The goals of root cause analysis are failure identification, analysis, and resolution through an iterative process.
In Industry there are lots failures related to the routine process, Equipment and System by one or other means.
So one must analyze control such failures in manner that it will not affect your ultimate output and obviously that is your Product and its Quality.
The document discusses implementing a holistic quality management system (QMS) by redefining corrective and preventive action (CAPA). It outlines challenges with traditional QMS approaches and regulations from ISO, FDA, and the European Commission regarding CAPA. The document recommends treating any opportunity to improve quality as a CAPA, and that CAPAs should follow a process from identifying problems to verifying the effectiveness of corrective actions.
Reliability Centered Maintenance (RCM) is a process that determines the best policies for managing asset functions and failures. It considers all asset management options like condition monitoring, scheduled restoration, and scheduled discard. RCM provides the optimal mix of reactive, time-based, condition-based, and proactive maintenance practices. When applied to commercial airlines in the 1970s, RCM reduced equipment-related crashes from 40 to 0.3 per million take-offs.
This document outlines a seven step process for Corrective and Preventive Action (CAPA) programs: 1) Identification, 2) Evaluation, 3) Investigation, 4) Analysis, 5) Action Plan, 6) Implementation, and 7) Follow-Up. It defines corrective and preventive actions and provides examples. A comprehensive CAPA process identifies problems, determines the root cause, develops a plan to fix the problem and prevent recurrence, implements the plan, and ensures effectiveness. The seven steps provide a framework to systematically address issues in a way that satisfies regulatory requirements and drives continuous improvement.
1. BACK TO
BASICS
Corrective vs. Preventive Action
by Russ Westcott
Q
uality professionals frequently mented as a preventive action). so you can wait and see progress
express confusion as to the dif- Consider the examples in Table 1. (Go and results.
ference between corrective and to www.asq.org, and click on the • Use a variety of appropriate dis-
preventive action. A corrective action cover of Quality Progress.) ciplines at different times during
deals with a nonconformity that has the project.
occurred, and a preventive action Corrective Action Process • Establish a means for communi-
addresses the potential for a noncon- • Locate and document the root cating what has been done and
formity to occur. Many ISO 9000 regis- cause of the nonconformity. what has to be done to facilitate
trar auditors tell their clients to use communication about changes to
separate procedures and forms to doc- project team members.
ument each type of action. Nothing in • Include a clear trail of actions
the standard says this must be done,
Knowing the taken and decisions made to sub-
but p. 13 includes the word “prevent” difference could make stantiate the decision to proceed,
in the clauses on corrective and pre- document lessons learned and
ventive action. all the difference. avoid needless reinvention on
On closer reading, however, section future similar projects.
8.5.2 says corrective action eliminates Documenting and controlling cor-
the cause of nonconformities to prevent • Scan the entire system to ensure rective and preventive actions ensure
recurrence, and section 8.5.3 says pre- no other similar nonconformity appropriate action is taken within a
ventive action determines and elimi- could occur. reasonable timeframe and the result-
nates the causes of potential noncon- • Analyze the effect such a noncon- ing changes work.
formities … to prevent occurrence. See, formity may have had on a prod-
there is a difference! uct or service produced before the BIBLIOGRAPHY
nonconformity was discovered, ANSI/ISO/ASQ Q9001-2000 Quality Man-
Common Misconceptions and take action appropriate to the agement Systems—Requirements, ANSI/
There are three common misconcep- severity of the situation by either ASQ, 2001.
tions about corrective and preventive recalling the product, notifying Robitaille, Denise, The Corrective Action
action: the customer, downgrading or Handbook, Paton Press, 2002.
Stamatis, D.H., Failure Mode Effect Analysis:
1. The standard calls for document- scrapping product.
FMEA From Theory to Execution, second
ing every occurrence of a non- • Establish thorough follow-up to edition, ASQ Quality Press, 2003.
conformity. ensure the correction is effective
2. A preventive action is really just and recurrence has been prevented. RUSS WESTCOTT is president of R.T. Westcott
calling a corrective action some- & Associates, Old Saybrook, CT. He is a Fellow
thing different. Preventive Action Process of ASQ and an ASQ certified quality auditor and
3. The major reengineering of a • Take proactive steps to ensure a quality manager. Westcott serves on several com-
process, product or service, or the potential nonconformity does not mittees of ASQ’s Quality Management Division
introduction of a new process or occur. and is a certified quality manager refresher course
equipment, is not a candidate for • Employ process and system analy- instructor. He is co-editor of several Quality
preventive action documentation. sis to determine how to build in Press books, including The Certified Quality
Manager Handbook and The Quality
One way to dispel these is by sepa- safeguards and process changes to
Improvement Handbook, and author of
rating situations into what I call a prevent nonconformance. For Simplified Project Management for Quality
patch (a single occurrence of a noncon- example, use a failure mode and Professionals.
formity that involves little risk and effects analysis to identify risks
needs not be recorded), a corrective and potential deficiencies and to
action (a more serious nonconformity set priorities for improvement. Please
involving some risk that requires comment
action to prevent recurrence and must Developmental Action Process
(Treated as Preventive Actions) If you would like to comment on
be recorded), a preventive action (a
this article, please post your remarks
process that can be improved to pre- • Initiate an improvement project,
on the Quality Progress Discussion
vent occurrence of a nonconformity with project plans, justification for
and is to be documented) or a develop- planned expenditures, resource Board at www.asq.org, or e-mail
mental action (a planned change to controls and evaluation. them to editor@asq.org.
introduce a new process or product in • Contain a related series of actions,
response to strategic objectives, docu- often separated by long periods
104 I MARCH 2005 I www.asq.org
2. BACK TO
BASICS
TABLE 1 Four Types of Action
Situation Frequency Suggested action Type Comment
Final inspection Single occur- Rework, repair. Patch. May not need to
returns part to rence before record; depends on
operator to cor- shipment. magnitude of risk
rect. Corrected and frequency.
part returned to
original lot.
Item or work unus- Single occur- Scrap. Patch. May not need to
able. rence before record; depends on
shipment. magnitude of risk and
frequency.
Item or service Serious. Assign for action Corrective action.
does not meet Occurred more (and contact
customer require- than once and customer, as
ments. after shipment. appropriate):
• Find root cause.
• Correct.
• Document.
• Evaluate
effectiveness.
Situation that Nothing has Assign for action: Preventive action. May require long-
could potentially occurred, yet. • Analyze what ifs. term follow-up to
affect process, • Evaluate poten- ensure effectiveness.
product or service tial effects of
is found. failure.
• Identify solution.
• Implement
solution.
• Document.
• Evaluate
effectiveness.
Desire to improve No nonconfor- Assign project: Developmental Organizations fre-
the process, prod- mance exists, • Analyze present action. Use preven- quently forget to take
uct or service for and no poten- process. tive action system credit for this type of
reasons other than tial for one is • Reengineer with project man- breakthrough pro-
nonconformance. detected. process. agement. ject.
• Document
process.
• Evaluate effec-
tiveness of
reengineered
process.
00 I MARCH 2005 I www.asq.org QUALITY PROGRESS I MARCH 2005 I 00