Cause Analysis And Corrective Action - Qualtrax
Cause Analysis and Corrective Action Webinar August 28, 2019 ANSI National Accreditation Board
Key Takeaways Definition of cause analysis Understanding the changes in ISO/IEC 17025 from 2005 to 2017 Understanding the corrective action process Understanding the difference between correction and corrective action How to evaluate the significance of nonconforming work
ISO 9001:2015 & ISO/IEC 17025:2017 “Laboratories that conform to this document (17025) will also operate generally in accordance with the principles of ISO 9001.” ISO/IEC 17025:2017 DOES include requirements of ISO 9001:2015
ISO 9001:2015 & ISO/IEC 17025:2017 Option A Address management system requirements (Clause 8) Option B Establish and maintain a management system in accordance with requirements of ISO 9001 Capable of supporting and demonstrating fulfillment of requirements in Clauses 4 to 7, and 8.2 to 8.9 in ISO/IEC 17025
Much less prescriptive React to nonconformity Evaluate the need for action Implement actions, as needed Update risks and opportunities Maintain records
Effective cause analysis Key to determining corrective actions that yield longlasting results Address the cause, not the symptoms Correction Corrective action Preventive action
The suitability of a corrective action cannot be determined without an identified cause The laboratory should identify and implement the corrective action(s) most likely to: Correct the problem Prevent recurrence
Definition of Cause Analysis Determination of a potential problem’s underlying cause or causes Process of identifying all causes that have or may have resulted in an undesirable condition, situation, nonconformity, or failure Analytical technique used to determine the basic underlying reason that causes a variance, defect, or risk
Potential Causes Related to Inputs People skills Planning Equipment Policies Consumables Outputs Customer requirements Training Design Standards Methods, procedures Materials Reports, records
Common Techniques Ishikawa (fishbone) diagram 5 why’s Failure mode and effects analysis (FMEA) Pareto chart
Ishikawa (fishbone) Diagram 6 M’s 4 S’s 8 P’s Machine Systems Price Method Skills Promotion Materials Surroundings People Maintenance Suppliers Processes Man Place Mother Nature Plant Policies Product Ishikawa diagram category examples
Five Whys Keep asking “Why?” until you get to a real cause You may get to a cause before asking “Why?” five times The first response If you keep asking, you may identify is usually a additional causes symptom
5 Why Example Why did I hurt my arm? I fell down
5 Why Example Why did I fall down? I tripped backwards over the dog
5 Why Example Why did I trip backwards over the dog? The dog was behind me trying to see what was in the shower
5 Why Example Why was the dog trying to see what was in the shower? There was a bat in the shower
5 Why Example Why was there a bat in the shower? The fireplace screen is broken
I hurt my arm Why? I fell down Why? I tripped backwards over the dog The dog was behind me trying to see what was in the shower Why? Why? There was a bat in the shower The fireplace screen is broken Why?
ISO/IEC 17025 Changes 17025:2017 8.7.1 When a nonconformity occurs, lab shall: a) React as applicable: Take action to control and correct it 17025:2005 4.11 4.11.1 Address consequences b) Evaluate need to eliminate cause Review and analyze nonconformity Determine cause(s) 4.11.2 Root Cause Analysis Determine if similar issues exist or could occur c) Implement any action needed 4.11.3 & 4.11.5
ISO/IEC 17025 Changes 17025:2017 8.7.1 (cont.) 17025:2005 d) Review effectiveness of corrective actions 4.11.4 e) NEW: Update risks and opportunities NEW f) Make changes to management system, if necessary 4.11.3
ISO/IEC 17025 Changes 17025:2017 17025:2005 8.7.2 Corrective actions shall be appropriate 4.11.3 NEW 8.7.3 Shall retain records: Nonconformities, cause(s) and actions Results of corrective actions Related to 4.13.1.1
React to the nonconformity Control and correct it Retain records Make changes to management system Corrective Action Process Address consequences Evaluate need for action to eliminate cause(s) Update risks and opportunities Review effectiveness Implement action
Corrective Action vs. Correction Corrective Action Correction Treats the cause Comprehensive actions Treats the symptoms Individual actions
Evaluating the Significance of Nonconforming Work Acceptability of nonconforming work Controls, reference standards, reference materials Impact analysis on previous results
Wrap-up There are many ways to perform cause analysis and arrive at the cause of a nonconformity Select the analysis method that suites your organization and the specific nonconformity being addressed
Effective cause analysis Saves time and money by solving a problem once Ensures that nonconformity does not recur
Training Offerings Introduction to ISO/IEC 17025:2017 Approaches to Risk-based Thinking in Laboratories Internal Auditing to ISO/IEC 17025 Fundamentals of Measurement Uncertainty Introduction to Data Validation Coming Soon! And more www.anab.org/training
Thank you Melanie Ross Training Products Specialist 414-501-5345 training@anab.org ANSI National Accreditation Board
Corrective action Preventive action The laboratory should identify and implement the corrective action(s) most likely to: Correct the problem Prevent recurrence The suitability of a corrective action cannot be determined without an identified cause Definition of Cause Analysis Determination of a potential problem's underlying cause or causes
corrective action for heating oil systems described in this document is modeled after the requirements in the Guide for Risk-Based Corrective Action at Petroleum Sites [ASTM E1739-05 (2002)], and is consistent with risk-based corrective action approaches included in many different corrective action programs implemented across the US.
RCRA Corrective Action may be implemented through a Corrective Action Order or Voluntary Agreement. If the findings of the RCRA Facility Assessment indicate the need for further investigation or corrective action, the facility will be required to perform a RCRA Facility Investigation (RFI). The RFI may propose that no further action is necessary.
Corrective Action Process 1.0 PURPOSE [1] This procedure provides instructions for the administration of Entergy (EN) Corrective Action process, including the identification, reporting, evaluation, and correction of a broad range of problems and areas for improvements. Issues addressed in the corrective action
Corrective Action Plan for John Adams High School House Bill 525 directs MS to develop a school improvement plan for schools identified as in need of “corrective action.” Investment School Corrective Action Plans were developed based on research about what makes urban schools successful.
5. Evaluation 6. Evaluation of previous cycle submitted corrective actions C. Eligibility 1. Data analysis 2. Program analysis 3. Corrective action planning 4. Implementation and Monitoring 5. Evaluation 6. Evaluation of previous cycle submitted corrective actions PERM Medicaid/CHIP CAP Regulatory Requirements Cont 8
Corrective Action, OP-102-01 Rev NC 5. - Schedule/Timeliness 5.1 - QNP Management will determine an appropriate time frame for the activities outlined in a CAR, as well as a time frame for any follow up activities. 5.2 - QNP Management is responsible for periodically reviewing open corrective actions to ensure that they are being investigated, acted upon, followed up for effectiveness and .
into compliance, or restate the finding as the root cause. Actual action taken to address the issue is often limited to “we retrained the operator”. The Nadcap approach requires you to analyze the cause(s) and take appropriate actions. There are numerous successful approaches to root cause corrective action and any of them can be used.
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