Corrective action plan implementation

At the conclusion of a walkthrough, safety-related issues identified should require have risk assessment and corrective action plan implemented. 

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. 

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. 

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. 

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. 

The Validation Report responds to the VMP, providing a summary of the actual approach taken and the documentation produced. Any deviations from the approach prescribed by the VMP must be justified and the consequence of the deviation assessed. Where the deviation is not acceptable, a corrective action plan must be formulated to address the issue. It may be possible that by implementing manual procedures to overcome the issue in the short term, the system will be enabled to move into the operational enviromnent while the issue is being addressed. 

The EPA expects that EMIS systems be implemented at aU major categorization facilities, and site implementation of such systems typically constitutes the first requirement of an EPA corrective action plan. As stated above, more accurate systems of emissions estimation can lead to reduced compliance burden and potentially eliminate the need for source classification adjustment. 

When you develop and implement a corrective action plan, consider the following questions ... 

What are the consequences of implementing or not implementing the corrective action plan ... 

What period is required for the corrective action plan to be implemented ... 

What impact will the development and implementation of the corrective action plan have on employee and/or other work areas ... 

The impact of all mitigating actions and sources of assurance are considered before calculating the residual risk. Reduction of each of likelihood and consequence depends on underlying subject issue and specific control considered. When the actual control plan is not correctly implemented, then the concerned person of the risk team and manager risk team need to think of improvement for action plan implementation and/or modify the framework for control action as warranted for the project. After completion of risk register, all risk should be populated in a consolidated risk matrix (or heat map) with risk IDs. Based on this, a report summary is put before management for consideration major points here are ... 

Physical audits evaluate the safety of working conditions and identify workplace hazards. First, determine where to conduct the audit. Always communicate with employees working in the area. List items of concern when documenting the audit results. Again, develop a follow-up or corrective action plan and implement it. 

A critical part of the audit process is the requirement that all audited States submit a corrective action plan to address deficiencies identified during an audit. As directed by the Council, all States are notified (by State letter and on the USAP secure website) of those states that are more than 60 days late in submitting a corrective action plan. As of 31 July 2007, there were seven States that were more than 60 days late. In the case of late corrective actimi plans, repeated reminders are sent to States, including at the level of the Secretary General and with the involvement of the applicable Regional Office, and ICAO assistance is offered should the State require advice or support in the preparation of its action plan. Extensive feedback is provided to each audited State on the adequacy of its corrective action plan, and an ongoing dialogue is maintained where necessary to provide support in the implementation of proposed actions. 

The engineer controlling the planned maintenance function within the department ensures that all work dockets are returned. Any comments entered on the work dockets are noted and, where further action is required, plans are prepared accordingly. Note A copy of the week tasks will suffice in maintaining a record of work dockets issued. If necessary, the technician/craftsman s initials can be entered on the week task form as a reminder to whom the work docket was issued.) Technicians/craftsmen should be advised of any matter that delays implementation of action required, as reported in the returned work docket, so that, if no corrective action has taken place on their next scheduled visit they understand why. 

Procedures should be established to periodically monitor all operations that may have an environmental impact, and similar scheduled periodic checks should be made to ensure that procedures and operations are still in line with regulatory and other requirements. If equipment is involved in the monitoring process then procedures should also be in place to ensure correct calibration. Procedures are also needed to record any preventative or corrective actions identified and to ensure that they are completed to schedule. The whole EMS should be audited periodically to check that it is consistent with the planned policy and has been properly implemented. The details of audits should be discussed and reviewed by management at the highest level with a view to continuous improvement through the modification of both policy and procedures. 

Activities documenting and tracking implementation of corrective actions or safety improvements are not part of a PrHA report. However, the PSM Rule requires a documented, integrated system for managing and monitoring action items. This system must assure that action items and recommendations are addressed and documented in a timely manner. Implementation schedules for corrective actions or safety improvements must be tracked. Finally, the system must assure that all affected operating and maintenance personnel and other affected employees are notified of planned actions. 

When action level excursions or frequent alert excursions are identified, a corrective action program, resolution deadline, and preventive plan shall be implemented. Risk analysis shall be performed to determine the probability of one or more causes of errors occurring, as well as to identify the potential consequences of excursions. (See attachment nos. 1700.80(1), 1700.80(J), and 1700.80(K), and 1700.80(L) for excursion of air, surface, personnel, and visual inspection report during the visit to plant by the microbiologist responsible.)... 

This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above. 

During qualification testing there may be instances in which the acceptance criteria for a particular qualification verification or test is not met. This must be identified (usually as a deviation) and the corrective action recorded, complete with plans for any retesting that may be required. The implementation of any resulting corrective action must be formally documented and test reruns approved and allocated a new test run number. 

The Generic Medical Implementation Plan also specifies that the systems contractor s quality assurance unit must conduct regular audits of the systems contractor s occupational health program and that an annual audit of the program must be conducted by PMCD-designated health care professionals. Reports of all audits are forwarded to the clinic medical director and the medical administrator for prompt action. Nonconformance requires a written plan for corrective action. 

Any corrective actions that are required must be defined and implemented in order to ensure that a validated state is achieved. The corrective actions must be scheduled and follow-up evaluations planned for monitoring and tracking their progress. 

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