Corrective Action By: Neal Stiemert Corrective Action One of the requirements of the ISO 9001:2000 standard is corrective action. The corrective action process is one opportunity to make permanent improvements in our processes if we perform corrective action as intended. The intention of corrective action is to identify our problem areas, correct them and put controls in place to prevent re-occurence. I recommend doing an ongoing trend analysis of the root cause of nonconformities to reveal if we are really doing corrective action or just putting band aids on our problems. As an auditor, I write a very large number of audit findings against the corrective action process. Typical audit findings are: Corrective actions closed without effectiveness verification. No due date assigned for closure of corrective action. Corrective actions not completed by the due date. ISO Requirement: (Key requirements are italicized) The organization shall take action to eliminate the cause 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… reviewing nonconformities (including customer complaints), determining the causes of nonconformities, evaluating the need for action to ensure that nonconformities do not recur, determining and implementing action needed, recording results of action taken (see 4.2.4), and reviewing corrective action taken. Corrective Action Acme takes corrective action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective action is appropriate to the effects of the problems encountered. The results of corrective action are presented for management review. The documented procedure for corrective action defines the requirements for… reviewing nonconformities (including customer complaints determining the causes of nonconformity evaluating the need for actions to ensure that nonconformities do not recur determining and implementing the corrective action needed reviewing and recording corrective action taken A Typical Procedure for Corrective Action Acme Operating Procedure Title: Corrective Action No. 14.1           Rev. A           Page 1 of 2 Approved by:     Little Johnny                             Date:     XX-XX-04             SCOPE: This procedure applies to corrective action for customer complaints, internal quality audit findings, internal product and process nonconformance and supplier nonconformance. 1.0   CORRECTIVE ACTION REQUESTED Corrective action can be requested by any person within the Acme organization by requesting a corrective/preventive action request (C.A.R.) form from Q.A. The initiator provides Q.A. with the information to fill a C.A.R. form. Q.A. logs in the C.A.R. in the corrective action file and assigns a C.A.R. number. The Q.A. Manager assigns the corrective action to the appropriate area manager. 2.0   CORRECTIVE ACTION Corrective action is performed by the person or supplier receiving the C.A.R. to correct the root cause of the problem which caused the nonconformance. Root cause analysis is necessary to prevent recurrence of the problem, or the corrective action is not considered acceptable. All necessary corrective action steps are taken to correct the process after the root cause of the problem is discovered. Corrective action steps may include any of the following: Training Revision of documentation (i.e. drawings, procedures, work instruction, etc.) Changes in the process After the area manager or supplier is satisfied that the corrective action is sufficient, the area manager or supplier fills out the corrective action section of the corrective action request form and gives it to the Q.A. Manager for review. 3.0   ACCEPTABLE? No - go to 3.1 Yes - go to 4.0 3.1   REJECT CORRECTIVE ACTION If the Q.A. Manager determines that the corrrective action does not include sufficient root cause analysis and effectiveness verification, the area manager or supplier must perform additional work to correct the source of the nonconformance. 4.0   CLOSE OUT CORRECTIVE ACTION After the Q.A. Manager determines that the corrective action is complete, adequate and effective, the C.A.R. form is signed and accepted by the Q.A. Manager. The C.A.R. form is filed in Q.A. along with any other accompanying documentation. The completed C.A.R. form is retained by Q.A. as a quality record. Notes: Acme shall respond to customers in the customer prescribed format. If a customer has a specific format or instructions to be followed for corrective actions, Acme shall respond as required. Customer corrective actions are faxed or emailed to the customer. The Q.A. Manager will determine the appropriate methods for problem solving using scrap reports, production data, similar part/process review, and a monthly cross-functional team. When applicable, Acme will use mistake proofing methods and apply corrective action to similar products and/or processes that may be effected. Acme Corrective/Preventive Action Request Corrective Action No.                     Date Issued                                    Issued To                                       Initiated By                                     Completion Due Date                     Description of Nonconformance                                                                                                                                                                                                                                                         Immediate Corrective Action                                                                                                                                                                                                                                                         Root Cause                                                                                                                                                                                                                                                         Permanent Corrective Action                                                                                                                                                                                                                                                         Effectiveness Verification                                                                                                                                                                                                                                                         Approved by                                                          Date                                      Summary Please remember…the existence of your company is dependent on your ability to deliver quality products and services that get to our customer on time. When problems arise such as nonconforming product, customer complaints or audit findings, we need to correct the root cause of the problem to prevent recurrence. Here are copies of the Corrective Action sample documents in PDF format:   Corrective Action Operating Procedure   Corrective/Preventive Action Request I hope this information helps you with your transition. Feel free to contact me with any questions at 800-959-0632. Neal Stiemert President Independent Quality Consultants, Inc. About the Author Neal D. Stiemert is President of Independent Quality Consultants, Inc. and holds a Bachelor of Science degree from Indiana University school of business. Neal is an ASQ Certified Quality Engineer, a certified lead auditor and has over 24 years of management, auditing, consulting and training experience in the quality profession. Neal has served as an examiner for the Minnesota Quality Award, an SPC instructor at Purdue University and an officer and committee member in the Chicago and Minnesota sections of ASQ. Neal also conducts registration audits for Smithers Quality Assessments and SAI Global Assurance Services. Comment on this article