Root Cause Corrective Action (RCCA) What do we need to know?

This is a *Mandatory requirement for us to stay in business. Why do we need to do this? To Put it simply; This is a *Mandatory requirement for us to stay in business.

Who is saying MANDATORY? ISO 9001:2008 4.1 General requirements The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.

Who is saying MANDATORY? ISO 9001:2008 4.2.4 Control of records Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records. Records shall remain legible, readily identifiable and retrievable.

Who is saying MANDATORY? ISO 9001:2008 5 Management responsibility 5.1 Management commitment e) ensuring the availability of resources.

Who is saying MANDATORY? ISO 9001:2008 4.1 General requirements The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.

Who is saying MANDATORY? ISO 9001:2008 5.5.2 Management representative Top management shall appoint a member of the organization's management who, irrespective of other responsibilities, shall have responsibility and authority that includes a) ensuring that processes needed for the quality management system are established, implemented and maintained, b) reporting to top management on the performance of the quality management system and any need for improvement, and c) ensuring the promotion of awareness of customer requirements throughout the organization.

Who is saying MANDATORY? ISO 9001:2008 8.5.2 Corrective action The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure shall be established to define requirements for a) reviewing nonconformities (including customer complaints), b) determining the causes of nonconformities, c) evaluating the need for action to ensure that nonconformities do not recur, d) determining and implementing action needed, e) records of the results of action taken (see 4.2.4), and f) reviewing the effectiveness of the corrective action taken.

Who is saying MANDATORY? TS16949 QMS (Currently Required by Caterpillar) 8.5.2 Corrective Action You shall Take action to eliminate the cause of nonconformities in order to prevent their recurrence Take action appropriate to the effects of the nonconformities encountered Define requirements in a documented procedure to: a) review nonconformities (including customer complaints) b) determine the causes of nonconformities c) evaluate the need for action to ensure that nonconformities do not re-occur. d) determine and implement corrective action needed e) record the results of actions taken f) review corrective action taken

Who is saying MANDATORY? AS9100 QMS Requirement Section: 8.5.2 The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure shall be established to define requirements for a) reviewing nonconformities (including customer complaints), b) determining the causes of nonconformities, c) evaluating the need for action to ensure that nonconformities do not recur, d) determining and implementing action needed, e) records of the results of action taken (see 4.2.4), f) reviewing the effectiveness of the corrective action taken, g) flowing down corrective action requirements to a supplier when it is determined that the supplier is responsible for the nonconformity, h) specific actions where timely and/or effective corrective actions are not achieved, and i) determining if additional nonconforming product exists based on the causes of the nonconformities and taking further action when required.

Who is saying MANDATORY? FAA U.S. DEPARTMENT OF TRANSPORTATION FEDERAL AVIATION ADMINISTRATION Air Traffic Organization Policy (1) Corrective action. The initial action or series of actions taken by the facility to correct the discrepancy. (2) Follow-up action. The action taken after an appropriate period of time to validate that the corrective action was successful. Documentation must include the date(s) that the follow-up action was accomplished and the results.

Types of CAR systems -Most Common- 8D Corrective Action System DMAIC Root Cause 5 Whys Root Cause Corrective Action System (RCCA)

-8D Corrective Action System- 1. Use Team Approach Establish a small group of people with the knowledge, time, authority and skill to solve the problem and implement corrective actions. The group must select a team leader. 2. Describe the Problem Describe the problem in measurable terms. Specify the internal or external customer problem by describing it in specific terms. 3. Implement and Verify Short-Term Corrective Actions Define and implement those intermediate actions that will protect the customer from the problem until permanent corrective action is implemented. Verify with data the effectiveness of these actions. 4. Define and Verify Root Causes Identify all potential causes which could explain why the problem occurred. Test each potential cause against the problem description and data. Identify alternative corrective actions to eliminate root cause. 5. Verify Corrective Actions Confirm that the selected corrective actions will resolve the problem for the customer and will not cause undesirable side effects. Define other actions, if necessary, based on potential severity of problem. 6. Implement Permanent Corrective Actions Define and implement the permanent corrective actions needed. Choose on-going controls to insure the root cause is eliminated. Once in production, monitor the long-term effects and implement additional controls as necessary. 7. Prevent Recurrence Modify specifications, update training, review work flow, improve practices and procedures to prevent recurrence of this and all similar problems. 8. Congratulate Your Team Recognize the collective efforts of your team. Publicize your achievement. Share your knowledge and learning.

DMAIC Define, Measure, Analyze, Improve & Control Each step in the DMAIC Process is required to ensure the best possible results. The process steps: Define the Customer, their Critical to Quality (CTQ) issues, and the Core Business Process involved. Define who customers are, what their requirements are for products and services, and what their expectations are Define project boundaries ­ the stop and start of the process. Define the process to be improved by mapping the process flow. Measure the performance of the Core Business Process involved. Develop a data collection plan for the process. Collect data from many sources to determine types of defects and metrics. Compare to customer survey results to determine shortfall Analyze the data collected and process map to determine root causes of defects and opportunities for improvement. Identify gaps between current performance and goal performance Prioritize opportunities to improve Identify sources of variation Improve the target process by designing creative solutions to fix and prevent problems. Create innovate solutions using technology and discipline. Develop and deploy implementation plan Control the improvements to keep the process on the new course. Prevent reverting back to the “old way”. Require the development, documentation and implementation of an ongoing monitoring plan. Institutionalize the improvements through the modification of systems and structures (staffing, training, incentives.

The following example demonstrates the basic process: Root Cause 5 Whys The following example demonstrates the basic process: The vehicle will not start. (the problem); Why? - The battery is dead. (first why) Why? - The alternator is not functioning. (second why) Why? - The alternator belt has broken. (third why) Why? - The alternator belt was well beyond its useful service life and not replaced. (fourth why) Why? - The vehicle was not maintained according to the recommended service schedule. (fifth why, a root cause) Corrective Action; Start maintaining the vehicle according to the recommended service schedule. (possible 5th Why solution) http://www.youtube.com/watch?v=IETtnK7gzlE

Success…starts with you! Let’s have a little fun… Let do a Root Cause Corrective Action together Pay attention to this event; Just sit right back and you'll hear a tale, A tale of a fateful trip…

RCCA That started from this tropic port

RCCA Aboard this tiny ship USS Minnow

RCCA The mate was a mighty sailing man

RCCA The skipper brave and sure

RCCA Five passengers set sail that day for a three hour tour, a three hour tour

RCCA The weather started getting rough The tiny ship was tossed, If not for the courage of the fearless crew …The minnow would be lost, the minnow would be lost.

RCCA The ship set ground on the shore of this uncharted desert isle;

RCCA All Members Survived

RCCA Details about the Tour and investigation (see handouts) The Skipper owns and operates this charter service.  The charter was scheduled to depart from Mariner Harbor at 9AM Friday June 13th and return Friday June 13th at 12 noon (3 hour tour). The weather was nice Monday June 9th thru Thursday June 12th. The Local News / Weather report posted weather conditions for Thursday June 12th through June Monday June 16th (see weather report) The Skipper watched the weather report June 13th at 7am Channel 7 KIRO. The Skipper is 3 months late on his boat payment. Each passenger pays $150 for the 3 hour tour General characteristics of Boat Name: USS Minnow Length: 38 ft 6 in (11.7 m) Installed power: 230 hp each Propulsion: Detroit Diesels (twin) Speed: 12 knots cruise, max 14 knots Capacity: 4 passengers Crew: 2 Last maintenance for the boat was done on June 5th. -Recommendations on the maintenance record stated; Number 4 cylinder of port side engine has low compression. Recommendation: Rebuild motor.

Weather Report

Root Cause Investigation RCCA Root Cause Investigation What was the main undesired condition? The boat Crashed onto the island in the lagoon What was the contributing factor(s) that caused the undesired condition? Let’s use the 5 Whys to help find the root cause. Why? Because the weather was rough. Why? Because the skipper chose to ignore the forecast. Why? Because the skipper needed the money, and did not want to cancel the tour. Why? Because the skipper was in debt. Why? Poor financial planning (he quit his stable job and bought a boat in hope to make money while doing what he enjoys most).

RCCA What is the Root Cause?

Poor financial planning and selfish act RCCA Poor financial planning and selfish act (that put others at risk)