Critical Role of Documentation in Risk Assessments
There are very few people who raise their hand when asked the question “who here likes documentation?” Documentation can be seen as an impediment to progress and efficiency, not to mention innovation. But in the long run, proper documentation goes along with proper and efficient planning. When it is looked at as a record of an effective plan, it isn’t too hard to see that documentation can be a necessary component to a well thought out and continuous planning process.
It’s hard to imagine designing, verifying and validating machine safety without a plan, and equally as hard to imagine successfully doing it without proper documentation. This article intends to provide some guidance on the process with the goal of helping all manufacturers more easily achieve safety.
The first question I would have would be when to start documentation?
You cannot start too early in generating documentation. As soon as you have the idea for the design it’s important to begin planning and further evolving the design of the product. Good written processes will shape, guide, sharpen and expedite the product development and the sooner that the intended purpose of the product is decided and documented; the sooner it can then become the seed for the ongoing product evolution. Consider that the mitigation means generated as an output of the initial hazard identification and risk assessment are the functional and performance requirements needed for the initial design, It is from this very point that the design begins to take shape.
Who should be involved?
Anyone with an interest in the design or production of a product should be able to make their contributions to product development as early as possible in the development lifecycle. The sooner that risks are identified and safety strategies are developed the easier and cheaper it is to include them into the design, by minimizing future design re-iterations and keeping a project on track. For example having production engineers involved in the initial design will minimize any future problems when the product is put into production.
Is it enough to design a safe system?
Actually no, the documentation that you develop is an important part of demonstrating to your customers that your product is safe. In fact, without sufficient documentation, it can be difficult to demonstrate that the product includes the required safety principles incorporated into the design. Inevitably you will also want to change the design of the product at some future date and documentation will allow you to make those changes by understanding where safety was incorporated into the original design and by understanding the effects of changing parts of the design.
But before you begin rushing into a design and doing a risk assessment, think about very carefully defining what the intended purpose (and any contra-indication or limitation) is for the product. Having a clear and unambiguous intended purpose statement is the necessary foundation of any risk assessment system; it defines the boundaries of applicability of hazards and maintains the overall direction of the design.
One of the best practices – and this applies for safety in general – is to incorporate the process requirements from the standard into the normal processes of the company. While many manufacturers will employ design controls from ISO 9001 for example, it is important to realize that the majority of risk assessment takes place before the initiation of the design controls of clause 7.3 in ISO 9001. The early stages of risk assessment involve the defining of the intended purpose of the machine, for which the statutory and regulatory requirements are established. Furthermore with the documented intended purpose statement, the functional, safety and performance requirements called for in design inputs are the targeted mitigation means used to control the risks of specific hazards and hazardous situations.
In many ways the risk assessment documentation also provides a consistent basis for demonstrating conformity to more quality system requirements of ISO 9001. Specifically, requirements for purchasing controls in clause 7.4 are essentially a risk assessment activity. Purchasing controls are mitigation means employed by a manufacturer to reduce the risk of obtaining non-conforming materials, components or outsourced services from a second party. Such non-conforming materials, components or outsourced services can lead to safety issues if the risks are not mitigated or understood by the manufacturer. Risk is a dynamic concept, and documentation employing traceability and means to re-assess risk is critical in obtaining growing confidence with second party suppliers.
It is not just in the design where this information is useful; it has even more applications in production. ISO 9001 asks the manufacturer to monitor and measure the products and the processes used during manufacturing.. Developing means to monitor and measure safety controls, components or process controls that are [traceable] mitigation means will yield the greatest contribution to safety.
When the product does not conform to original specifications, and concessionary release is being proposed, the risk assessment file provides the necessary and critical information needed to demonstrate that the product is in fact safe.
As you see planning without documentation is not effective. The documentation provides the evidence of a safe design. Ideas, decisions, problems and their respective scope and solutions that are documented can be refined and iterated into the evolving design, documenting such matters keeps the design team on the same path and helps prevent second guessing and going over old ground.
However it is all too easy to become overburdened and overrun with generating documentation. Sensible precautions taken in the early planning phase should identify if any documentation is needed. However the documentation generated, particularly in regards to hazard identification and risk analysis, is also an investment in intellectual property helping to optimize design and development processes, ready to be used for the next design project.
The information in the risk assessment file helps to provide input into design, production and management decisions. The reasons why a decision needs to be made is easily justified from the risk assessment file and the inherent traceability. So the next time someone asks “what should we do?” Put your hand up and say “I know… let’s look at the documentation!”
Article written by Kevin Connelly, UL LLC
Have an Inquiry for Siemens about this article? Click Here >>