Corrective action plan

The Corrective Action Plan (CAP) relies on the sequential performance of activities which are conventional engineering practices. These activities include problem identification, development and evaluation of alternatives, and the implementation of the selected alternative. The three analogous phases identified in the CAP are as follows ... 

Interim measures may be separate from the comprehensive Corrective Action plan but should be consistent with, and integrated with, any longer-term Corrective Action (e.g., corrective measure through an order, an op erating permit, a post-closure permit or interim status closure requirements). To the extent possible, interim measures should not seriously complicate the ultimate physical management of hazardous wastes or constituents, nor should they present or exacerbate a health or environmental threat. Interim measures may add additional costs or work to the comprehensive Corrective Action. Such added costs or work do not preclude implementation of an interim measure. 

U.S. EPA. 1988a. RCRA Corrective Action Plan -Interim Final EPA/530- SW-88-028, OSWER 9902.3, Office of Solid Waste and Emergency Response, Washington, D.C., June 1988. 

The Corrective Measures Study (CMS) elements as outlined in the EPA document entitled RCRA Corrective Action Plan - Interim Final (U.S.EPA, 1988) provides guidance to the regulatory community on the steps practiced by the engineering community in the conduct of a feasibility study. These steps include ... 

The standard requires suppliers to quantify, anafyze, and reduce all nonconforming product fay establishing a corrective action plan and tacking progress. 

Your corrective action plan should therefore address as appropriate ... 

Your planning and delivery procedures need to record estimated and actual delivery dates and the data collected and analyzed through a delivery performance monitoring procedure. When targets are not met you should investigate the cause under the corrective action procedures and formulate corrective action plans. Where the cause is found to be a failure of the customer to supply some vital information or equipment, it would be prudent not to wait for the periodic analysis but to react promptly. 

Thorough investigations should be conducted according to a predetermined SOP to ensure that the root cause is identified, if not already obvious. Once this has been done, a corrective action plan must be agreed and the process closed out by verifying that the corrective or preventative action has been implemented effectively. 

Compiling detailed corrective action plans if further corrective action is found to be... 

U.S. EPA, How to Evaluate Alternative Cleanup Technologies for Underground Storage Tank Sites A Guide for Corrective Action Plan Reviewers, EPA 510-R-04-002, U.S. EPA, Washington, 2004. 

Monitoring corrective action plans and schedules can be done manually. However, a computerized database can also be used to track all corrective actions. A computerized tracking system is of particular benefit when a large number of activities must be monitored. As a minimum, the system for tracking the status of corrective actions should ... 

Corrective action, broadly defined, includes not only the process of addressing identified deficiencies, weaknesses, or vulnerabilities, but also the processes for corrective action planning and follow-up. The corrective action process can be summarized as follows. 

When nonconformances occur, the corrective action plan is activated. Anyone seeing the need for corrective action is responsible for reporting the problem to the proper supervisor or manager. Merely correcting the particular unsatisfactory product does not achieve corrective action. If possible, the root cause of the unsatisfactory condition is determined, and a proposed remedy is put in place. The effectiveness of the corrective action is verified. 

The report should document any corrective action or change that is required to make the software acceptable. Corrective action plans should document responsibilities and the rectification date, and where applicable record the change control reference number. Resolution of any problems should be reported under the DQ. 

An evaluation report must be generated for each computer system, which summarize the current operation of the computer system, allocates its priority, provides a reference to any supporting documentation, and identifies the compliance gaps in the system. Based on the information in the evaluation reports, a Corrective Action Plan can be generated. 

The purpose of the Corrective Action Plan is to define the overall activities, schedule, costs, and responsibilities necessary to guide the development and implementation of technological and procedural controls to bring the systems into compliance with Part 11. The plan should identify any existing technological/procedural controls that may be modified or new technological/procedural controls that need to be implemented in order to ensure that the regulatory requirements are completed in a consistent and uniform manner. The remediation action items identified in the Part 11 assessment should be documented in a detailed implementation plan. 

Once the corrective action plan has been approved, it can then be executed. 

During the remediation phase, the computer systems are brought into compliance by implementing the procedural and technological controls determined by the Corrective Action Plan. In addition, the processes needed to sustain the compliance solutions are implemented. 

Once the Corrective Action Plan is approved, the computer technology suppliers and developers are requested to identify how the deficiencies can be overcome. When appropriate, procedural controls need to be developed in order to address the deficiencies that cannot be solved by technological controls. 

The Corrective Action Plan should be periodically reviewed because the evolving technology requirements will need to be considered and the plan revised accordingly. 

The corrective action plan may be contained within a validation plan. The validation plan is a document that describes the company s overall philosophy, intentions, timetable, and approach to be followed for the corrective action compliance program. The approach to be taken may consist of writing procedures, performing verifications, and/or performing qualification activities. Refer to Chapter 19 for information on remediation project. 

Formally communicate your summary report to the vendor. Ensure that a corrective action plan from the vendor will be provided. Update the report in accordance with the vendor response. Use this audit summary... 

Definition of roles and responsibilities for corrective action plans Standard operating procedures governing corrective actions Auditing frequency and general access to site records Change control... 

A table of contents for SOPs and/or test methods—to familiarize the audit team with the procedures available for review and plan in advance which procedures to concentrate on during the audit Previous FD-483s received by the vendor, along with their corrective action plans. A company dress code for visitors—to determine if there are any special dress needs related to safety or the environment being audited... 

An exit conference is generally conducted to allow the auditors an opportunity to present a summary of the results or findings of the audit. This includes both positive findings and any areas identified for improvement. Providing a written summary prior to leaving the vendor s facility allows the vendor to begin working on the corrective action plans. 

As a result of the audit, the vendor is responsible for developing a corrective action plan to address any weaknesses or deficiencies identified by the sponsor s auditors. It is the sponsor s responsibility to ensure that the corrective... 

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