Recommendations, from investigations

Each recommendation should he brief (two or three lines only), sufficient to identify a particular topic, and individually numbered to facilitate management of follow-up and resolution. If appropriate, each recommendation should have appended a cross-reference number to enable a fuller explanation, description, or argument to be extracted from other sections of the report in support of the recommendations. Some investigators recommend adding a column to the table entitled Evidence which allows the team to tie in important pieces of evidence to the findings and identified causes. In effect, this column answers the questions, How do we know this Why do we believe this is a cause ... 

A large portion of these common events can be linked to less than adequate follow-up of recommendations from previous incident investigations. The earlier investigation teams may have properly identified underlying root causes, submitted suggested preventive actions, and attempted to share results yet the repeat occurrences continue due to incomplete implementation of recommendations or ineffective sharing of lessons learned between potentially affected parties. 

Figure 18.1 Study design for the pre- and postnatal development evaluation in the cynomolgus monkey. Maternal treatment is either discontinued at term or is continued into the lactation period in order to investigate transfer of test item to the infant. Transfer of biopharmaceuticals via milk has been observed in this species. The duration of the postnatal observation period is variable and not yet standardized. In our laboratory the longest postnatal observation period covered 720 days. A variety of parameters is available for testing infant development (see also Table 18.4 for details). For biopharmaceuticals, a minimum period of 6 months appears appropriate. If the behavioral test battery comprises learning tests that are recommended from the age of 6 months onward, infants should be observed for at least 9 months.

Are all recommendations from PHA studies, incident investigations, and audits resolved in a timely fashion ... 

Number of open recommendations (from risk analyses, incident investigations, audits, safety suggestions) X ... 

However, because of the possibility of a smallpox attack, albeit remote, in December 2002 President Bush announced his preevent vaccination plan. Instead of mass vaccination, the plan, based on recommendations from the CDC, the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC) makes smallpox vaccination available for people designated by public health authorities to conduct investigation and follow-up of initial... 

The restricted-unrestricted approach not only improves results from the unrestricted approach, but also allows to rigorously describe the effect of spin polarization for tlie hyperfine coupling constants as well as to provide ways to analyze the behavior of spin polarization (response term in RU approach, see fheory part) in problematic cases. The RU approach therefore provides a higher degree of control over the calculation and its analysis compared to the unrestricted formalism. It can consequently be recommended for investigations of hyperfine coupling constants in various molecular systems. 

The above discussion reinforces recommendations that investigations designed to assess potential adverse effects from RCAs should include detailed studies and considerations not only of the active RCA but also any formulation constituents and the total formulation itself (Ballantyne, 1977a, 1987 Ballantyne and Salem, 2004). 

Dilution of 1° and 2° antibody incorrect - The dilutions of the 1° and 2° antibodies had not been tested rather dilutions were selected from those recommended. To investigate the antibody dilutions, a Dilution Matrix was done, and the results are shown in Fig. 14.2. These results show that at the dilutions... 

Traditionally, an investigators committee will take full charge of the clinical development from Phase I or Phase Ila through Phase III (Figure 27.4). The committee consists of a chairman, a senior leader in his speciality who is chosen by the pharmaceutical company. The chairman recommends key investigators and well-known experts to the sponsor. 

In response to recommendations from the NRC, the PMACWA sponsored separate investigations to provide a basis for optimizing engineering parameters for the hydrolysis of energetic materials. Many of these investigations had not yet been completed when this report was prepared. 

Following the fire and explosion at BP s Texas City refinery in Texas City, Texas, in the year 2005, the CSB conducted an investigation. One of the recommendations from that investigation called for the American Petroleum Institute (API) and the United Steel Workers (USW) to work together to develop an ANSI standard for leading and lagging indicators. The recommendation reads ... 

Access, lighting, and housekeeping standards Existing risk assessment process [hazard and operability (HAZOP), MOC, unit startups, work permitting] Recommendations from prior and current incident investigation teams... 

Recommendations from incident investigations were often not implemented. Senior managers had a top down approach to patient safety and did not engage staff in the development of safety solutions. Sustainability of solutions would be achieved if frontline staff were engaged in developing solutions, rather than having them imposed from above. 

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