Corrective action report

Many organizations use a Nonconformity Report to deal with the remedial action and a Corrective Action Report or Request (CAR) to prevent the recurrence of one or more nonconformities. In this way you are not committed to taking action on every incident but on a group of incidents when the action and its cost can be more easily justified. 

You will need a means of recording both the cause and the proposed solutions. You can either incorporate the information within the Nonconformity Report or provide a separate Corrective Action Report. 

This contains two separate requirements one for verifying that the prescribed action has been taken and the other for verifying that the action has been effective in eliminating the original nonconformity. The Corrective Action report should define the corrective action to be taken, the actionee, and the date by which it is to be completed. The action-ee should report when the action has been completed in order that it may be verified. The effectiveness of some actions can be verified at the same time but quite often the effectiveness can only be checked after a considerable lapse of time. Remember it took an analysis to detect the nonconformity therefore it may take further analysis to detect that the nonconformity has been eliminated. In such cases the report should indicate when the checks for effectiveness are to be carried out and provision made for indicating that the corrective action has or has not been effective. 

If the root cause is assignable, corrective action needs to be taken and documented. If three consecutive runs over action levels occur, a problem analysis corrective action report (PACAR) must be issued. 

Upon completing Tier 1 Review, the analyst documents it in a checklist and compiles data packages, which include calibration and QC sample data, sample results, raw data, and support documentation (bench sheets, copies of the COC Form, review checklists, corrective action reports). These packages, which become part of the project file, then undergo a Tier 2 Review. 

Corrective adion is the term used to describe the identification and remediation of errors occurring within an analysis. Corrective action is necessary whenever the result of the analysis of any quality control sample falls outside of the established control limits. The steps involved may include simple things like checking calculations of basic instrument maintenance, or it may involve more complicated actions like major instrument repair. Whatever the source of error, it must be identified and corrected (and a Corrective Action Report (CAR) must be completed. CARs should be kept on file by the laboratory. 

Review of response to Corrective Action Reports issued... 

Explain the steps taken by the client s or principal contractor s staff to monitor safe working conditions on the project, and the action which is to be taken on receipt of a copy of the principal contractor s weekly and monthly inspection reports, and other Corrective Action Reports ... 

There are seven worksheets for major cause categories, and there is an additional worksheet, found at the end of the seven, to put all causes into summary form creating one easy to look at form. It contains one direct cause, one root cause, and up to three contributing causes, their descriptions, and any corrective actions. The contributing causes, which should be listed and have corrective actions, are those that can result in the most effective benefit when corrected. Even though only three contributing causes can be reported, and their corrective actions reported, corrective actions should be made on all identified causes. 

The project manager of the work shall engage on behalf of the owner the services of a special inspector to observe construction and prepare quality records and nonconformity and corrective action reports. 

In sub-chapter 18-2, the scope of audits is defined to be applicable to all research, development, design, procurement, construction, fabrication, operation, and decommissioning of the SRS reactors. It further establishes the commitment to report findings as either nonconformances or corrective action reports for tracking and ultimate resolution. Sub-chapter 18-3 sets forth a plan to audit external organizations for their compliance with the QA manual. This allows for the audits of vendors and suppliers and further demonstrates an overall commitment to the assurance of Quality in all aspects of design and its control. The items discussed above demonstrate that the requirements set forth in Restart Criterion 6 are satisfied. 

Customer Complaints. A failure in a company s quaUty system often shows up in the form of a customer complaint. These reports of nonconformances, whether for product or service deficiencies, are typically received by the sales or customer service organization and then channeled to QA. Quahty assurance often tracks the progress and coordinates the complaint investigation. Once completed, it is QA that reviews the report of the investigation and corrective action for thoroughness and efficacy. QuaUty assurance then either passes the information along to the sales or customer service organization or contacts the customer direcdy. 

Transmission of more than one value from a transmitter. Information beyond the measured variable is available from the smart transmitter. For example, a smart pressure transmitter can also report the temperature within its housing. Knowing that this temperature is above normal values permits corrective action to be taken before the device fails. Such information is especially important during the initial commissioning of a plant. 

As follow up, document the implementation of corrective actions taken by the toller. Keep this documentation with the initial inspection report that lists the deficiencies for which actions were taken. 

If yes, for each incident, attach the incident report or give the following information Description of the incident, chronology of verifiable events, other pertinent facts, root causes and contributing factors, and proposals for corrective action. 

Check whether a documented system is in place, which covers the reporting, investigation, root cause analysis and corrective actions taken. 

Air emissions at point of discharge should be monitored continuously for fluorides and particulates and aimually for ammonia and nitrogen oxides. Monitoring data should be analyzed and reviewed at regular intervals and compared with the operating standards so that any necessary corrective actions can be taken. Records of monitoring results should be kept in an acceptable format. The results should be reported to the responsible authorities and relevant parties, as required. 

Each deficiency, corrective action, schedule and responsibility must be recorded and tracked with periodic status reports, engineering studies, implementation and closure report. These reports are sent to affected management and staff. 

Although not a specific requirement of the standard, the requirements in clause 4.14.2 imply that corrective actions resulting from design reviews should be tracked to ensure they are implemented as agreed and that they resolve the reported problem. 

The standard does not make it clear whether these requirements apply to nonconformities detected while the supplier is responsible for the product or after the supplier s responsibility ceases, as is the case with nonconformity reports received from customers. Reports of nonconformities are also addressed under Corrective Action in clause 4.14 but it is assumed that in this case the standard is concerned with external reports of nonconformities. 

The standard requires the corrective action procedures to include the effective handling of reports of product nonconformities. 

All nonconformities are caused, all causes within your control can be avoided - all that is needed is concerted action to prevent recurrence. There are three types of corrective action product-related, process-related, and system-related. Product-related nonconformities can be either internal or external, as addressed previously, and you will have nonconformity reports to analyze. Process-related nonconformities may arise out of a product nonconformity but if you expect something less than 100% yield from the process, the reject items may not be considered nonconformities. They may be regarded as scrap. By analyzing the process you can find the cause of low yield and improve... 

Your corrective action procedures need to cover the collection and analysis of product nonconformity reports and the collection and analysis of process data to reveal process nonconformities. The corrective action provisions of your internal audit procedure need to address the causes of the nonconformities and you will need an additional procedure to deal with external audits, investigating the cause of any nonconformities and recording the results. The procedure also needs to cover the investigation of customer complaints as the previous requirement only deals with the handling of complaints. 

The report should also make provision for the proposed solution to be approved or rejected. Remember that anyone may investigate nonconformities and propose corrective actions but the responsibility for taking the corrective action rests with those responsible for the process (see Part 2 Chapter 1 under Personnel who initiate action to prevent nonconformity). 

Provide links between the corrective and preventive action reports and document, product, process, and organization changes. 

You should set up a common entry point for such data and put in place an evaluation function to convey appropriate data to the manufacturing, engineering, and design activities. A corrective action form or improvement form could be used to convey the data and obtain a written response of the action to be taken. A log of servicing reports would assist in tracking servicing concerns and demonstrate you were making effective use of the data. 

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