Action Planning Document

The European Technology Platform for Sustainable Chemistry (Strategic Research Agenda and Implementation Action Plan documents) http //www.suschem.org/. 

Action level— The amount of a material in air at which certain OSHA regulations to protect employees take effect. Exposure at or above the action level is termed occupational exposure. Action plan—Documented outline of specific projected activities to be accomplished within a specified period, to meet a defined need. 

To develop an action plan, identify the specific action items that need to be implemented. Keep to the facts and do not get into too many details. Action items should pinpoint events and critical steps to consider during implementation. Once the plan is designed, responsibility for each step can be assigned, along with an estimated target date. Refer to Appendix B for a sample action plan document. 

EXAMPLE ACTION PLANNING DOCUMENT Compliance Program—Lockout and Tagout (LOTO)... 

What records Keep written procedures, including training and education program information Keep a copy of the workplace emergency action plan Document previous training received as part of the community... 

Action plan documented outline of specific projected activities to be accomplished within a specified period, to meet a defined need... 

An action plan shoiild be developed by the appropriate personnel of the audited facility to address any deficiencies stated in the audit report. Action plans should state what is to be done, who is responsible for getting it done, and when it is to be completed. Ration e for not taking any action for any of the stated deficiencies should also be documented. The action plan is an important step in closing the audit process. 

It would not be unusual for some action plans to take a long time to complete. When extended implementation time is necessary, a follow-up mechanism should be used to document progress and show that an effort is being made to resolve the issues. Periodic (i.e., quarterly, semiannually) progress reports should be used as a follow-up method to ensure implementation. Future audits of the facility should include confirmation of the implementation of previous audit action plans. 

The final audit report, action plans, progress reports, and any closure report should be retained by the facility based on the facihty record retention pohcy. Typically, these items will be retained until future audit documentation replaces them. In some cases, audit records are retained for the life of the plant. 

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 ... 

At the strategic level, boiler water treatment practice is essentially the planned, actioned, and documented management of the waterside of pre-boiler, boiler, and post-boiler plant equipment and systems. A key objective is to identify, obtain, and maintain operational and economic benefits for the plant owners, including maintaining the cleanliness and structural integrity of the boiler, its various water-steam cycle auxiliaries, and other components for a specified (long-term) period and to some quantifiable standard. 

U.S. EPA has issued regulations and guidance primarily focusing on double liners and LCRSs.6 7 Several Federal Register notices and guidance documents have been published by U.S. EPA in this area.8-11 U.S. EPA also issued final regulations for double liners and for LDSs, including construction quality assurance (CQA) and response action plans.12-14... 

European Commission (2004) European Action Plan for Organic Food and Farming, Commission Staff Working Document SEC (2004) 739. 

Contingency Plan A pre-planned document presenting an organized and coordinated plan of action to limit potential pollution in case of fire, explosion or discharge of hazardous materials which defines specific responsibilities and tasks. 

A short synopsis of the overall emergency management structure, how other industrial emergency response, contingency, and risk management plans fit into the ERP for chemical emergencies, and applicable policies, procedures, actions plans, and reference documents should be cited. Policies should include interconnect agreements with adjacent communities and just how the ERP may affect them. 

Modem cooling water treatment practice is the planned, actioned, and documented management of cooling systems to produce and maintain operational and economic benefits for the users. 

Existing system applications will need to be evaluated and applicable GMP issues and risks identified. Whether it be legacy systems, systems to be revalidated, or systems yet to be validated, the critical parameters, data, and functions that direcdy impact GMP should be clearly identified and formally documented. Each system should be assessed under a formal procedure to determine compliance with the regulations for electronic records and electronic signatures. Any resulting action plan should include system prioritization and implementation timings. 

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. 

The system owner, system administrator, system user, and system support personnel must participate in regular periodic reviews of the validated system. Upon completion of the periodic review, the findings must be documented and an action plan developed to correct any gaps found during the assessment. 

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. 

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. 

Dr. Butler has created a service blueprint for the Med Check Program at Feel Great Pharmacy. She will also create a service blueprint for each of the Stay Fit Program components. These documents will help her to implement the new services in her pharmacy. Similarly, she has an action plan for one part ofher newprograms. Dr. Butler can add more details to the current action plan and later expand it to encompass both programs. This approach allows her to coordinate all the tasks that need to be completed for Feel Great Pharmacy to offer the new goods and services. 

Internal QA audits must be conducted and documented at a defined frequency to ensure overall compliance, control, and effectiveness of the quality elements. Such audits should be conducted by members of the QAU or third-party compliance specialists and the results reported directly to the senior management of the corporation. The senior management should prepare an action plan to address any deficiencies and follow up to confirm adequate implementation. 

Designing a corrective action plan—Along with the ability to audit and evaluate the status of documentation and organizational practices is the need to know how to address and correct deficiencies that are identified. Audit activities should always be paired with the development of a comprehensive enhancement plan that addresses, corrects, and prevents all deficient practices observed during the audit. An audit without this corrective and preventative counterpart is at best useless and at worst quite dangerous if the noted deficiencies go uncorrected. 

TRAININC, DRILLS, AND EVALUATION Emergency response most be documented and records retained review Evacuation drill Initial and annual refresher training for employees involved in emergency response varies with roles-All employees trained in Emergency Action Plan Initially and with every chunge to plan. Training In MSDS Information ... 

---