INADEQUATE implementing

The follow-up inspection is limited to specific GMP requirements that have not been observed or that have been inadequately implemented by the manufacturer. 

CIM implementation is a very important but also very complex process. It requires the participation of many people with different disciplines. Benefits can be gained from successful implementation, but loss of investment can be caused by inadequate implementation. Therefore, much attention should be paid to CIM implementation. 

Inadequate implementation of the controls that designers assumed would exist during operations. 

Manuele (1997a) believes the domino theories are too simplistic. He proposes the term unsrrfe act also be eliminated. He suggests the chief culprits in accident causation are less-than-adequate safety policies, standards, and procedures and inadequate implementation accountability systems. Manuele attempts to pull different causation theories together into one working theory. His approach also incorporates some of the following ideas. 

Inadequate implementation of policies, plans, processes, programs, and procedures... 

Severe accident procedures are generally not used, but in case of necessity their use is significant for safety in the plant and off site. Inadequate implementation of accident management procedures due to lack of training can increase the potential for radioactive releases. These procedures are important to prevent the progression of accidents as well as to mitigate the effects of any releases. 

Process Hazards Analysis. Analysis of processes for unrecogni2ed or inadequately controUed ha2ards (see Hazard analysis and risk assessment) is required by OSHA (36). The principal methods of analysis, in an approximate ascending order of intensity, are what-if checklist failure modes and effects ha2ard and operabiHty (HAZOP) and fault-tree analysis. Other complementary methods include human error prediction and cost/benefit analysis. The HAZOP method is the most popular as of 1995 because it can be used to identify ha2ards, pinpoint their causes and consequences, and disclose the need for protective systems. Fault-tree analysis is the method to be used if a quantitative evaluation of operational safety is needed to justify the implementation of process improvements. 

The supplementary requirements provide a welcome addition to this somewhat inadequately specified clause of ISO 9001. However the reference to clause 4.1.1.2 with respect to objectives specified in the quality policy is somewhat ambiguous. Clause 4.1.1.2 does not require objectives to be included in the policy this is required in clause 4.1.1.1. As stated previously, system effectiveness is judged by how well the system enables implementation of policy and achievement of objectives. Therefore, requiring records that contain evidence of this is a logical interpretation. Such records need to identify the matters reviewed, the results, the actions, and the decisions taken, together with the names of those responsible and the date by which actions are to be completed. The records should also contain the data used to conduct the review as the basis upon which the decisions have been made and so that comparisons can be made at later... 

If an element has a formal system that isn t followed, this suggests either a problem with the system itself (e.g., flawed design, impractical, insufficient detail or explanation) or a failure of management (e.g., inadequate supervision, lack of training, no followthrough or enforcement, or inadequate resources). Whatever the cause, you will want to make note of it and try to address it in your implementation plan. 

The result of ineffective maintenance management represents a loss of more than 60 billion dollars each year. Perhaps more important is the fact that our ineffective management of maintenance dramatically impacts our ability to manufacture quality products that are competitive in the world market. The loss of production time and product quality that results from poor or inadequate maintenance management has had a dramatic impact on our ability to compete with Japan and other countries that have implemented more advanced manufacturing and maintenance management philosophies. 

The methodology described In this paper has evolved over the past ten years but still remains very elementary It was developed to minimize the exceptional hazards associated with the design and Implementation of accelerated life tests Many accelerated life tests can be characterized as expensive failures, due to the use of poor experimental designs. Inadequate scientific and statistical expertise, and Insufficient peer review prior to Implementation The methodology outlined below Is Intended to reduce such failures ... 

This is rarely the case in engineering. Most of the time we do have some form of a mathematical model (simple or complex) that has several unknown parameters that we wish to estimate. In these cases the above designs are very straightforward to implement however, the information may be inadequate if the mathematical model is nonlinear and comprised of several unknown parameters. In such cases, multilevel factorial designs (for example, 3k or 4k designs) may be more appropriate. 

The most effective means of implementing a safety program is to make it everyone s responsibility in a chemical process plant. The older concept of identifying a few employees to be responsible for safety is inadequate by today s standards. All employees have the responsibility to be knowledgeable about safety and to practice safety. 

Inadequate process safety management practices are often cited as the cause of reactive incidents, as discussed in Section 3.0 (Table 4). Incident data underscore the critical importance of successfully implementing the following key elements throughout the life cycle48 of a manufacturing process ... 

If management decides to reject, modify, or delay implementation of a recommendation, it is a good practice to document the reasons for not accepting or implementing the recommendation as submitted by the investigation team. A common and avoidable mistake is to provide inadequate documentation for this decision. An example of inadequate documentation would be a brief entry in the record to the effect that this recommendation is not considered justifiable, with no further explanation. Examples of more adequate reasons for not accepting a recommendation may be the recommendation did not specifically address a root cause, or the recommendation is not technically feasible. In either case, an alternate recommendation should be presented. 

Our understanding of practical implementation issues is inadequate currently. Such issues encompass (1) a better understanding of how the path for financial incentives translates into actual investments in R D ... 

Processing and Fabrication, Ceramics are traditionally prepared from powders formulated from the individual oxides however, early attempts to produce the PLZT powders by this method proved to be inadequate from the standpoint of chemical and optical uniformity. As a result, a chemical co-precipitation method designed specifically for the PLZT materials which utilized liquid precursor materials was developed and successfully implemented as a production process (15),... 

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