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Tel. 610-489-4392

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Process Development

  • A Process is a repeatable set of steps set to complete a task with consistency and accuracy. There are times when processes seem overbearing because it might involve many steps, however when a process is successfully created it allows employees to work more efficiently and safely.

 

  • For a process to be successful you need the following qualities in your process plan:

    • Established

    • Repeatable

    • Ownership

    • Compatible

    • Executable

    • Sustainable

    • Effective

 

  • Established

    • No matter what the process plan is for the results of that plan must be successful. It must be shown that using the same process steps multiple times has the desired outcome. The process plan should also have backing on why the steps are completed in the manner that they are. The plan must also combat false data or incorrect inputs.

 

  • Repeatable

    • The process must be repeatable in such a manner that it can be used by any trained personnel. If it is only repeatable with one employee or third party, then it is not a successful process plan.

 

  • Ownership

    • Ownership is a key to the success of a process plan.

      • Workers like to be able to give input during process development. When they are allowed to have some input, the workers tend to have more attachment to the process, so they try harder to make it a success.

      • The employees working full time hours at production/import/sales facilities know the system best. Employee engagement will help weed out discrepancies between the current work process and the process plan being developed.

 

  • Compatible

    • The process must be compatible with all departments and interfaces. Any additional work around activities will make the plan inefficient. One such example is using Mindjet software to complete the work for a client who does not have mindjet. There will be an additional step required to make it compatible with the clientele. This is not a successful plan.

    • Product Regulatory Services has a the capability to check if all steps in the process are compatible. We also offer regulatory compatibility checks. If you are interested in learning more please contact us below.

  • Executable

    • If the process cannot be performed without struggle, then it is useless. The process plan is supposed to make the activity less challenging. If the process is difficult to complete or overbearing it might be in your best interest to redesign the process. Some cases there is no work around a challenging process due to the nature of the hazard, However you can streamline as many step as possible to make it a little less difficult.

    • There is a potential that both the product design and the manufacturing process could be flawed. the best approach to these situations is to take both the product design and the manufacturing process to the black board. Here you will consider what can be done to the flaws to make it successful. In most cases, the initial design is used as a framework for the new design changes. However, one must be careful not to spend time on a process that will never work.

 

  • Sustainable

    • High stress level environments have been proven to not be sustainable. Employee turnover will increase while the product quality will decrease. In cases where this trend is noticed it is important to look at both the product design and the production facility. Sometimes making a couple changes have a positive effect on workers.

    • There are cases where the product manufacturer process can not be altered to not include a high stress environment. Additional conditions should be required to keep personnel safe. One such condition to try is  having a rotating work crew. This allows the work to be split up by entire work crew and not only a couple working in the stress environment all the time. The employees can rotate daily, or they can rotate hourly.

    • Product Regulatory Services can help assess the worker condition and the components hazardous risk. We can advise on potential strategies to less the high stress environment.

 

  • Effective

    • The process must be successful and provide the desired results. If the outcomes are not meeting your expectations, then the process is a failure and must be redesigned. Also be aware that results that are not ethically determined could have a negative influence on the team. Sometimes it is hard to make a decision when it is all the gray zone. The best approach would be to think safety first. If safety is disregarded in anyway it could lead to negative impact on company presence.

  • Product Regulatory Service provides a service where we can check your current process plan. We will report if we see any weak spots, bottlenecks, and/or stress points with your current process. We can also help advise on how to adapt to those stress points and make your process successful. Our team specializes in working closely with any team to help them understand the process and use it more efficiently.

  • Product Regulatory Services LLC
  • PRS_Regulatory
  • Product Regulatory Services LLC