The Corrective Actions System

Implementation of corrective actions is the responsibility of management. In assigning corrective actions, management may consult with the PrHA team to assure full understanding of the hazards identified in the PrHA before corrective actions are taken. 

If an action item appears in a PrHA report and management chooses not to implement a corrective action, then the justification for not doing so must be documented and made part of the PrHA records. If management approves a particular corrective action and it is not implemented, justification must also be documented as part of the PrHA records. 

Management review of the action items from a PrHA of a large or complex process may result in many corrective actions and safety improvement activities. These actions should be prioritized to facilitate timely implementation. 

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  

All documentation and tracking information must be up to date, readily available, and easy to audit. 

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Do capture your organization s recovery plans into the corrective action system. 

The corrective action system should be the repository for all follow up actions required in the compliance program. The source for corrective actions, which need to be tracked, might include the following ... 

Supervisors must be trained in developing and monitoring the corrective action system. Ongoing monitoring of safety behaviors allows the supervisor the opportunity to correct safety issues before they become serious [2]. 

Because we were unable to identify the methyl anthranilate component within the sensitivity of the equipment used for these tests, we resorted to an examination of the ethanol loss (Figure 11). After a sampling time of 65 hours for each sample, the sample of CC14 was injected. The amplitude of the peak at 1 minute 58 seconds retention time (peak for ethanol) was examined. The two tests proved that the corrective action on the container was effective. Less than 10 6 grams of ethanol (the sensitivity limit of the system) had escaped from the corrected sample container, whereas 1.5 X 10 4 grams of ethanol had escaped from the uncorrected sample. (See Figure 11, which shows the two traces.)... 

Unanticipated events that occur should be recorded in computer system maintenance records and include what corrective action was taken, who performed the corrective action, and when the action occurred. These events might include system crashes, date/time changes after a power failure, etc. 

To control the corrective action process, many companies make use of a tracking system. To assist in the tracking of corrective actions, a variety of reporting mechanisms can be used, such as ... 

If the failure repeated represents a potential for product concern, a corrective action system should be activated. This system should contain provision for the following ... 

Improving the foundation of manufacturing science in our current manufacturing practices should be the primary basis for moving away from the corrective action crisis to continuous improvement. Knowledge of the variation theory is, therefore, an essential element of manufacturing science. It requires an in-depth understanding of a process or system (15) ... 

Acid leaks result in the deactivation of some chemical treatment programs, for example, P-PO4 is hydrolyzed to O-PO4, and chromate (in the presence of ferrous ions) is reduced to trivalent chromium. Also, depassivation of the inhibitor film and corrosion occurs. The correct action is to first stop the leak, then to increase the pH by bleeding off the low pH water and making up, to the maximum extent of the system. If the leak is so severe that the pH drops below 4.3, and free mineral acidity (FMA) occurs, soda ash should be used to restore the pH to 4.3 to 4.5, then discontinued. Caustic soda should not be added, as this action will almost certainly result in heavy fouling from precipitated ferric hydroxide. Dispersants or antifoulants may be required. When the system is stabilized, it should be repassivated and the reason for the acid leak resolved (faulty pH meter ). 

In order to illustrate the method, we can take the example of a pump as a component. It may fail to start or to stop when requested, provide too low a flow rate or too low a pressure, or present an external leak. The internal causes for pump failure may be mechanical blockage, mechanical damage, or vibrations. The external causes may be power failure, human error, cavitation, or too high a head loss. Then the effect on the operation of the system and external systems must be identified. It is also useful to describe the ways for detecting the failure. This allows establishing the corrective actions and the desired frequency of checks and maintenance operations. 

In September 1994, the NMSHTD retained a second consultant, Daniel B. Stephens Associates, Inc. (DBS A) to design and implement a corrective action system at the Artesia Patrol Yard. Sections 3.1 and 3.2 outline DBS A s rationale for and design of the high-vacuum SVE system for the Artesia Yard. The techniques used to enhance the recovery of petroleum vapors from the vadose zone are described in Sections 3.3 and 3.4. These techniques extended the operation of the high-vacuum SVE system and allowed a more effective cleanup of the vadose zone in preparation for the current phase of bioventing. 

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. 

In order to remedy problems quickly or to avoid system errors, appropriate procedural controls must be applied to (a) enable early identification of an imminent breakdown, and (b) initiate appropriate preventive action. The next section suggests a course of action to follow to identify, analyze, and record computer system incidents, and to implement and test the corrective action taken. 

One such approach is called cascade control, which is routinely used in most modern computer control systems. Consider a chemical reactor, where reactor temperature is to be controlled by coolant flow to the jacket of the reactor. The reactor temperature can be influenced by changes in disturbance variables such as feed rate or feed temperature a feedback controller could be employed to compensate for such disturbances by adjusting a valve on the coolant flow to the reactor jacket. However, suppose an increase occurs in the coolant temperature as a result of changes in the plant coolant system. This will cause a change in the reactor temperature measurement, although such a change will not occur quickly, and the corrective action taken by the controller will be delayed. 

This observation is one of the most common received relative to OOS investigations and deviations. A comprehensive investigation may have been performed and a definitive cause found for the aberrant data, but there is no documented system in place to ensure that the corrective action committed to in the investigation report will be effected in its entirety and in the allotted time frame. 

Ensure that the corrective action goes beyond the specific citations and addresses the underlying systemic deficiency. 

When a problem is indicated by the control systems, Project Managers will need to bring all their skills into play in rapidly analysing the situation and making a decision on the corrective action to be taken. A good Project Manager will maintain an intimate contact with all aspects of the project and be able to anticipate problems and take avoiding action before they arise. 

A certified poison center or system shall demonstrate that patient outcomes are monitored regarding high-risk, high-volume, or problem-prone cases. The corrective actions taken to improve patient care shall be documented. In addition, the certified poison center should demonstrate monitoring of customer satisfaction and assessment of staff competency. 

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