All Hazards Risk Assessment Template: Fill & Download for Free

How to do Risk Assessment for Investments?In this case, it’s all about managing the chances you will not get a Return on Investment, or not within the estimated time needed. A good way to assess risks of an investment, is by making a Risk Assessment Matrix.This way, you are already thinking about risks and measures to control them. A general risk assessment helps you to identify and prevent issues from happening. You can easily make a Risk Assessment Matrix in Excel or Word, together with your Management Team or other stakeholders.It’s important to work with a Risk Assessment Template that meets your company or industry needs. Check out the Risk Assessment Template in order to find a better way to understand and manage risks. The following columns are important in a Risk Assessment template:Potential hazard;Who is at risk?;Existing control measures;Risk rating;Preventive measures;Responsibilities.How important is it to manage the risk?To define the importance of the risk, and the chance of happening, you can rate the risks according the RAG system. R stands for the Red color (danger), A stands for Amber color (be careful) and G stands for the Green color (low importance). stands The RAG status can be defined by making an analysis of two variables:1) Likelihood, for example different grades:Almost certain (e.g. >90% chance)Likely (e.g. between 50 and 90% chance)Moderate (e.g. betweem 1-% amd 50% chance)Unlikely (e.g. between 3% and 10% chance)Rare (e.g. < 3% chance2) Consequences:Insignificant (Minor problem easily handled by normal day to day process)Minor (Some disruption possible, e.g. Damage equal to $500K)Moderate (Significant time/resources required e.g. Damage equal to $ 1 MLN)Major(Operations severely damaged, e.g. Damage equal to $ 10 MLN)Catastrophic (Business survival is at risk damage equal to $ 25 MLN)After filling in the blanks in your Investment Risk Assessment Template and defining the impact of the risks, you are able to keep a better control over your risks and are challenged to find control measures.Source: Risk Assessment Template

First you do a risk assessment and then do a hierarchy of of controls to reduce or eliminate the risk. You must factor in the costs though. There must be a viable Return of Investment or you won’t get support from management.Know that it is nearly impossible to eliminate all risks, but we can attempt to manage them. There will always be a human factor.Now then, this may be above your paygrade, but if you are a worker there are things you can do. First, if you have identified a hazard then do what you can to fix it. Wet or oily floor? Grab a mop or absorbents and clean up the area. Or barricade the effected area and notify your supervisor. If you see a risky behavior, such as misusing a ladder, stop the person and fix the problem. Use the ladder properly, get a proper ladder, or use a working platform. If that is not possible, stop work and notify your supervisor.15+ Risk Assessment TemplatesHierarchy of Controls | NIOSH | CDC

Traceability matrices are critically important to an FDA submission, as well as to sane, professional project management. Traceability matrices are effectively the tool the FDA expects to be used as a checklist, showing that you followed your process to complete your product. Note: don’t mistake “matrix” for an Excel spreadsheet, however.FDA regulations are not technical regulations in the same sense as DoD or FAA technical requirements are in their respective industries. The FDA uses a set of meta-design process models which it expects to be detailed in each company’s QMS/design process procedures. The key models on the device side are:Plan/Requirement/Protocol/Data/Report. This structure is the default, a plan, prepare, execute record of development activity.Good Manufacturing/Clinical/Laboratory Practices. GMP/GLP/GCP is all about repeatable results and is the basis of the original FDA regulation of the medical device/pharma industries. You see it in the formal language of the agency, i.e. a violation or serious breach.Hazard/Risk Assessment/Mitigation/FMEA. Quality risk management focuses on identifying specific hazards, identifying the level of risk, mitigating, or redesigning where necessary, then reviewing the design implementation for hazards that went unrecognized in the initial analysis. This becomes a measure of robustness in the design - if a fault occurs that was not identified and mitigated in the design, then there is a design fault. If the fault and mitigation is identified, then you can probably say the design worked as expected, even if the situation is not desirable.Process design, IQ, OQ, PQ quality process.Mitigation, quality and manufacturing processes, process measures and data, monitoring. Quality process monitoring is a significant part of the design effort. Many faults should be identified here, before a deviceCorrective and Preventive ActionEach of those systems in a company has a role in documenting your thinking, implementation, and problems that come up. A key principle is that no one expects the development to be problem-free. Everyone should expect that problems, changes, and proof that the problem was corrected should be documented. Conversely, a clean, waterfall documentation chain with no changes or problems should be treated as a clear flag that the design history is a fraud.So for every part of product design, electrical, software, hardware, chemical, and material, there should be a characteristic record. Starting with design standards, appropriate templates, drawings, and revisions are created and stored in an appropriate repository. A snapshot of the repository should give you a complete change history with descriptions to that point in time.Every part of the design history should be a time-stamped, revision-controlled document that can be compared to past and future versions of the documentation meaningfully to produce red-lines and drawings with a demonstrable relationship to products.Traceability is the general language used to refer to maintaining documented relationships in the development process.Requirements for V&V test protocols.Requirements to implementation.Requirements to completed testing.Test failures, requirements changes, and observations to design changes.Revision to implementation or product.Effectively tying the paperwork together in the corporate documentation system. Traceability acts to tie a design history together with the physical result, evidence that a set of goals or requirements were met, and quality control history.QSIT “Quality System Inspection Technique”, the auditing approach used extensively by the FDA, uses the traceability relationships to drive an audit. Starting virtually anywhere, but often with a problem or design change, the auditor can use the traceability to drill down into the design history. In a perfect world, the auditor will find a well-described history, problem discovery, analysis, design change, testing and introduction, and monitoring in manufacturing. The traceability matrixes make that information discoverable, and everything discoverable should be complete, and consistent with your documented processes, no more or less.Internally traceability should solve a number of project management challenges. A hazard assessment and requirements drawing define the goals of the design, the traceability defines a complete set of deliverables. The completion, review and release of the elements in the traceability matrix is the only important, visible measure of progress and the only important measure of objective completion.