Risk assessment documentation

Validation With respect to validation, the agency intends to exercise enforcement discretion regarding specific Part 11 requirements. However, compliance with all applicable predicate rules for validation is still expected. The FDA suggests an approach to validation be based on a justified and documented risk assessment and a determination of the potential of the system to affect product quality, safety, and record integrity. 

No documented risk assessment and hazard analysis was done. [FDA 483, 1996]... 

Qrganizations often establish a review panel to conduct periodic reviews. Before the panel meets, the chairman should estimate the scope of the review, the time needed to undertake the review, and determine the size and composition of the review panel. The level of review should be based on a documented risk assessment. Members of the review panel should include operations... 

Notwithstanding this increase, Ihe strategy of the insp torate well as that of the EXYPPs) is orientated towards improving employers awareness of the need for documented risk assessments overall. Actual measurement of exposure is estimated to feature only in around 10 per cent of written risk assessments. Policy documents and comments from health and safety practitioners shed light on this approach. For example, a circular to inspectors from the Miiiistry of Labour mak it clear that the immediate objective of the Labour Inspectorate should be to ... 

The completed change documentation, risk assessment, and justification for risks not mitigated shall be submitted to the relevant vice president for approval. 

The existing OHS MS in the organization was very rudimentary. Significant attempts had been made to perform and document risk assessments, as required... 

Informing the patient about the nature of pharmacy preparations is not yet common practice in many countries. In the UK patient leaflets on this topic are available [88]. They explain both the preparation in the pharmacy and off label prescribing of licensed medicinal products. Both situations have in common that physician and pharmacist will of course act according to disease-specific professional guidelines or following a documented risk assessment. 

The requirements for the premises may turn out to be quite moderate, provided that they are based on a well-documented risk assessment. It will at least imply that premises shall be exclusively dedicated for preparation activities, e.g. shall not give direct access to toilets and will have to be physically separated from any public area. The layout should not compromise a logical sequence of activities. Specific gowning and cleaning procedures must apply. 

Before a prescription with a request for a pharmacy preparation can be approved, it has to be decided whether there is a specific clinical need for it. When defining the place in therapy, part of the assessment is the risk that is presented to the patient or a patient group both from receiving the preparation and from not receiving the preparation because it would not be available [3]. The risk should be estimated on the basis of a documented risk assessment (see Sect. 2.2.3) and the outcome of the assessment is recorded in the product file. 

Safety professionals can expect that being able to make documented risk assessments will be necessary for their job retention and career enhancement. That premise has acquired weight because of the more frequent inclusion of risk assessment provisions in safety standards and guidelines. ANSI/AIHA ZlO-2005 is an example. Other standards and guidelines requiring such provisions are discussed in Chapter 9, Including Risk Assessment Provisions in Standards and Guidelines A Trend. ... 

The National Fire Protection Association (NFPA) develops and issues fire codes that are used by fire marshals and the authority having jurisdiction to enforce required fire safety measures. NFPA issued the new NFPA 45-2015 Standardfor Fire Protection for Laboratories Using Chemicals which included Chapter 12 on Educational and Instructional Laboratory Operations. This new section established new requirements for teachers and instructors who perform demonstrations. Instructors performing demonstrations must perform a documented risk assessment, provide a safety briefing to students, provide adequate personal protective equipment (PPE), and use secured safety barriers between the student and the demonstration to prevent personal injury unless there is at least 10 feet between the demonstration and the students. Institutions are required to train instmctors in fire safety procedures, emergency plans, hazards in the laboratories, use of PPE, and how to conduct risk assessments. 

Finally, document your risk assessment and management plan. This ensures colleagues understand the risks and can follow the plan. Should things go wrong - which they will, at some point - a well-documented risk assessment will show you did what you could at the time. It also helps you consider whether anything else could have been done, should a similar situation arise in the future (Box 8.2). 

This database provides scientific and technical information on the environment. The information is compiled from a set of Royal Society of Chemistry databases. Environmental Chemistry, Health Safety contains information on chemicals deemed to cause actual or potential problems to humans or the environment. The subject coverage is broad and includes such varied topics as animal and microbiological hazards, biological effects of chemicals and radiation, corporate environmental issues, legislation and standards, transportation and storage of chemicals, waste management. Environmental Chemistry, Health Safety can be used to document risk assessment, to assess potential environmental, health, and safety problems, and to study a company s environmental and safety experiences. 

U.S. EPA. 2000. Benchmark Dose Technical Guidance Document. Risk Assessment Forum, Washington, D.C. EPA/630/R-00/001. October. 

The ECPI approach has been adopted by the European Commission in their "Technical Guidance Document on the Risk Assessment of Notified New Substances" as the model for assessment of environmental exposure from additives in plastics. It is important to note, however, that due to the effect of ultraviolet degradation and microbial attack, a significant proportion of the emissions from flexible PVC consists of plasticizer degradation products. In these instances, therefore, the level of plasticizers appearing in the environment will be significantly less than indicated by the plasticizer loss data. 

EH 72/7 1,2-Diammoethane (ethylenediamme (EDAJJ risk assessment document... 

A risk assessment analyses systems at two levels. The first level defines the functions the system must perform to respond successfully to an accident. The second level identifies the hardware for the systems use. The hardware identification (in the top event statement) describes minimum system operability and system boundaries (interfaces). Experience shows that the interfaces between a frontline system and its support systems are important to the system cs aluaiion and require a formal search to document the interactions. Such is facilitated by a failure modes and effect analysis (FMEA). Table S.4.4-2 is an example of an interaction FMEA for the interlace and support requirements for system operation. 

Murphy, J. A., Probabilistic Risk Assessment (PRA) Reference Document. September 1984. 

Brown, D. F., W. E. Dunn, and M. A. Lazaro, 1997a, CASRAM The Chemical Accident Stochastic Risk Assessment Model Technical Documentation, BetaVersion 0.8, ANL,... 

In any case, the risk assessment must be documented in a suitable report, including the existing working conditions and the reasons for the chosen pro cedures. It should contain, at least, the following data ... 

Technical Guidance Document in Support of the Commission Directive 93/67/EEC on Risk. Assessment for New Notified Substances and the Commission Regulation (EC) 1488/94 on Risk Assessment for Existing Substances, European Commission, 1996. 

It is important to remember that unexpected benefits may arise from integration. You should actively look for these benefits and document them. It may be possible to improve some of these benefits by small modifications to the plan or integration framework. Such additional work should be undertaken only with the appropriate approvals. Never the less, if any benefits would only be achieved with the integration project, you should include them in your overall statement of benefits. An example of this might be the better allocation of capital to risk reduction efforts when an integrated risk assessment is done-addressing several different types of risk. 

Leverenz, F. L. and D. C. Cox. Probabilistic Risk Assessment Course Documentation, Volume 6, NUREG/CR-4350, U. S. Nuclear Regulatory Commission, Washington, DC, 1985. 

If there are specific data germane to the assumption of dose-additivity (e g., if two compounds arc present at the same site and it is known that the combination is five times more toxic than the sum of the toxicitics for the two compounds), then tire development of the hazard index should be modified accordingly. The reader can refer to the EPA (1986b) mi.xiure guidelines for discussion of a hazjird index equation that incorporates quantitative interaction data. If data on chemical interactions are available, but arc not adequate to support a quantitative assessment, note the information in the assumptions being documented for the risk assessment. 

Concise International Chemical Assessment Documents (CICADs) are published by the International Programme on Chemical Safety (IPCS) — a cooperative programme of the World Health Organization (WHO), the International Labour Organization (ILO), and the United Nations Environment Programme (UNEP). CICADs have been developed from the Environmental Health Criteria documents (EHCs), more than 200 of which have been published since 1976 as authoritative documents on the risk assessment of chemicals. 

CEC (2003) Technical guidance document on risk assessment in support of Commission Directive 93/67/EEC on risk assessment for new notified substances and Commission Regulation (EC) No 1488/94 on risk assessment for existing... 

EPA. 1988d. Reference dose (RfD) Description and use in health risk assessment. Vol. I, Appendix A Integrated risk information system supportive documentation. U.S. Environmental Protection Agency, Office of Health and Environmental Assessment. EPA 600/8-86-032a. 

---