Risk Management

This category includes a variety of frameworks that involve rating of evidence. Examples include GRADE3 (Guyatt et al., 2011), WHO‐IARC (IARC, 2006), WCRF/AICR (2007), OSHA (2016) and guidance used to produce NTP Monographs (NTP, 2015; OHAT, 2015). Guidance to assess and integrate evidence is based on several factors, often derived from the Bradford‐Hill considerations. However, ‘Rating’ builds on the approaches of the category ‘Causal criteria’ in that more guidance is provided for appraising and integrating evidence.
These approaches usually relate to the second step of the weight of evidence process, including the appraisal of individual studies and rating confidence in the individual lines of evidence (e.g. ‘high confidence,’ ‘sufficient evidence’). Some of them also provide tools based on a matrix for integrating lines of evidence to reach hazard identification conclusions (WHO‐IARC, OHAT, OSHA (2016)). None of these approaches use formal probabilistic techniques, but it is possible to combine application of the structured framework guidance with a more quantitative presentation of conclusions.
Some of these approaches (e.g. GRADE) are designed to be flexible for use in a variety of disciplines and able to be applied under different time and resource constraints in situations corresponding to different levels of urgency (Thayer and Schünemann, 2016).
In EFSA, the scheme presented in the ‘Guidance on a harmonised framework for pest risk assessment and the identification and evaluation of pest risk management options’ (EFSA, 2010a) belongs to this category.

The Safety Attitudes Questionnaire (SAQ) is a refinement of the Intensive Care Unit Management Attitudes Questionnaire, [14 (link),15 ] which was derived from a questionnaire widely used in commercial aviation, the Flight Management Attitudes Questionnaire (FMAQ). [16 ,17 ] The FMAQ was created after researchers found that most airline accidents were due to breakdowns in interpersonal aspects of crew performance such as teamwork, speaking up, leadership, communication, and collaborative decision making. The FMAQ measures crew member attitudes about these topics.
Because 25% of the FMAQ items demonstrated utility in medical settings in terms of the subject covered and factor loadings, they were retained on the SAQ, The new SAQ items were generated by discussions with healthcare providers and subject matter experts. In addition, we relied upon two conceptual models to decide which items to include: Vincent's framework for analyzing risk and safety [8 (link)] and Donabedian's conceptual model for assessing quality [18 (link)] This generated a pool of over 100 new items covering four themes: safety climate, teamwork climate, stress recognition, and organizational climate. Items were evaluated through pilot testing and exploratory factor analyses. This phase of survey development consistently yielded 6 factor-analytically derived attitudinal domains containing 40 items from the survey (two, three, four, and five factor structures were less robust). Three of the targeted themes, safety climate, teamwork climate, and stress recognition, emerged as factors. In particular, safety climate and stress recognition are conceptually quite similar to their counterparts in aviation. [19 ] The fourth targeted theme, organizational climate, consistently emerged as three distinct but related factors, perceptions of management, working conditions, and job satisfaction. Organizational climate plays a decisive role in setting the preconditions for success or failure in managing risks [3 ,4 (link),20 (link)] , and we therefore retained these three factors as part of safety attitude assessment. An additional 20 items were retained because they were deemed interesting and valuable to the unit managers and senior hospital leadership to whom we reported the results of our pilot studies.
The SAQ has been adapted for use in intensive care units (ICU) [15 ,21 ] , operating rooms (OR), general inpatient settings (medical ward, surgical ward, etc.), and ambulatory clinics. For each version of the SAQ, item content is the same, with minor modifications to reflect the clinical area. For example, "In this ICU, it is difficult to discuss mistakes," vs. "In the ORs here, it is difficult to discuss mistakes." The SAQ elicits caregiver attitudes through the 6 factor analytically derived climate scales: teamwork climate; safety climate; job satisfaction; perceptions of management; working conditions; and stress recognition (Figure 1).
The SAQ is a single page (double sided) questionnaire with 60 items and demographics information (age, sex, experience, and nationality). The questionnaire takes approximately 10 to 15 minutes to complete. Each of the 60 items is answered using a five-point Likert scale (Disagree Strongly, Disagree Slightly, Neutral, Agree Slightly, Agree Strongly). Some items are negatively worded. There is also an open-ended section for comments: "What are your top three recommendations for improving patient safety in this clinical area?" Each version of the SAQ in the current study includes a "Collaboration and Communication" section, where respondents are asked to indicate the quality of collaboration and communication they have experienced with each of the types of providers in their clinical area (e.g., Staff Surgeons, Surgical Residents, Staff Anesthesiologists, OR Nurses, etc.) using a five-point Likert scale (Very Low, Low, Adequate, High, Very High).

It should be noted that the text in green italics throughout this Guidance aims to provide practical guidance to the assessors to conduct the commodity risk assessment.The Panel performs its commodity risk assessment following the relevant guiding principles and steps presented in the EFSA guidance on quantitative pest risk assessment (EFSA PLH Panel, 2018), in the guidance on evaluation of the effectiveness of risk‐reducing options (EFSA PLH Panel, 2012) and in the International Standard for Phytosanitary Measures No 11 and No 21 (FAO, 2004, 2013a). It should be noted that the Panel's conclusions are formulated to respect its remit and particularly with regard to the principle of separation between risk assessment and risk management (EFSA founding regulation (EU) No. 178/2002).
The data and supporting information provided in the dossier submitted by the applicant form the basis of the commodity risk assessment. In evaluating the dossier provided, EFSA PLH Panel assumes that the applicant followed the instructions contained in the Technical Report (EFSA, 2018).
Guidance is provided on the methodology to be used in the commodity risk assessment and concerns the evaluation of commodity data, identification of pests potentially associated with the commodity and evaluation of the risk mitigation measures.
Examples of databases that could be used for checking the completeness of the information provided are listed below:

EPPO Global Database (https://gd.eppo.int/)

CABI Plant Protection Compendium (https://www.cabi.org/cpc/)

The Plant List (http://www.theplantlist.org/)

Index Fungorum (http://www.indexfungorum.org/)

MycoBank (http://www.mycobank.org/)

NEMAPLEX (http://plpnemweb.ucdavis.edu/)

Fauna Europaea (https://fauna-eu.org/)

EUROPHYT

USDA Agricultural Research Services (https://nt.ars-grin.gov/)

bibliographical databases

statistical databases

When performing a commodity risk assessment, the databases used to check the completeness of the information provided should be explicitly mentioned.At several points in the risk assessment process, additional information may be required. Figure 1 gives an overview of the points in the assessment process when this may be the case. This could include requests for clarifications or additional documentation from the applicant.

The study was performed in the region Eindhoven, south-eastern part of the Netherlands, in 145 general practices affiliated to the primary care group PoZoB. The care group covers rural, suburban and urban practices similar to other parts of the Netherlands and therefore can be considered as representative. Between 2010 and 2013, 137 practices (406,119 registered patients) followed a stepwise implementation for integrated care and another 8 practices started implementation between 2013 and 2015. Eligibility for participation in integrated CVRM care was based on in- and exclusion criteria given in Table 1. Details of the stepwise implementation have been described elsewhere [16 (link)].Table 1

Criteria for participation in the CVRM program ^a

Inclusion criteria for patients eligible for primary prevention
● A 10 year cardiovascular mortality risk > 5%, based on the SCORE table from the 2006 CVRM guidelines of the Dutch Society of General Practice [6 (link)]
● Prescription of blood pressure lowering or lipid modifying drugs in men aged ≥ 55 years and women aged ≥ 60 years
● Systolic blood pressure > 180 mm Hg and/or total cholesterol > 8 mmol/l ever measured, independent of the 10 year mortality risk
● The patient is primarily treated in primary care and aged 18 years or above
Inclusion criteria for patients eligible for secondary prevention:
● Documented previous ischemic or atherosclerotic heart disease (myocardial infarction and angina pectoris), heart failure, atrial fibrillation, aneurysm of the abdominal aorta, peripheral arterial disease, transient ischemic attack, ischemic or hemorrhagic stroke, chronic kidney disease
● The patient is primarily treated in primary care and aged 18 years or above
Exclusion criteria for both groups were:
● Primarily treated for cardiovascular disease risk by a specialist in a hospital or at an outpatient clinic
● Diabetes mellitus (patients receive cardiovascular risk management in a diabetes care program)
● Patients younger than 18 years

^aCVRM program: cardiovascular risk management program

The Panel performed the pest categorisation for P. ananatis, following guiding principles and steps presented in the EFSA guidance on quantitative pest risk assessment (EFSA PLH Panel et al., 2018 (link)), the EFSA guidance on the use of the weight of evidence approach in scientific assessments (EFSA Scientific Committee, 2017 (link)) and the International Standards for Phytosanitary Measures No. 11 (FAO, 2013 ).
The criteria to be considered when categorising a pest as a potential Union QP is given in Regulation (EU) 2016/2031 Article 3 and Annex I, Section 1 of the Regulation. Table 1 presents the Regulation (EU) 2016/2031 pest categorisation criteria on which the Panel bases its conclusions. In judging whether a criterion is met the Panel uses its best professional judgement (EFSA Scientific Committee et al., 2017 (link)) by integrating a range of evidence from a variety of sources (as presented above in Section 2.1) to reach an informed conclusion as to whether or not a criterion is satisfied.
The Panel's conclusions are formulated respecting its remit and particularly with regard to the principle of separation between risk assessment and risk management (EFSA founding regulation (EU) No 178/2002); therefore, instead of determining whether the pest is likely to have an unacceptable impact, deemed to be a risk management decision, the Panel will present a summary of the observed impacts in the areas where the pest occurs, and make a judgement about potential likely impacts in the EU. Whilst the Panel may quote impacts reported from areas where the pest occurs in monetary terms, the Panel will seek to express potential EU impacts in terms of yield and quality losses and not in monetary terms, in agreement with the EFSA guidance on quantitative pest risk assessment (EFSA PLH Panel et al., 2018 (link)). Article 3 (d) of Regulation (EU) 2016/2031 refers to unacceptable social impact as a criterion for QP status. Assessing social impact is outside the remit of the Panel.