That is an interesting point to bring up. Within my current company, I have seen how teams are not allowed bring in more individuals even though the workload has increased. And it is unfortunate because it puts more burden on the current employee. To solve this current issue, the company tends to hire more contractors rather than employees through company based on necessary projects requirements. So once the project is completed and the team is required to be reduced, it is easier to terminate the 1-year or 2-year contract and can have the option to renew the contract if necessary. This allows the company to outsource the resources for the projects and maintain the flexibility to add or remove depending on the budget requirements.

Hi Fady!

Unfortunately, companies are constantly under budget restrictions, and sometimes this leads to an entire department to go through a hiring freeze or a travel freeze. Although new engineering projects start in R&D and core team leaders need employees to take on the workload, the managers of the R&D department do not allow them to hire new employees because of the budget. Currently, the company that I work for is in a hiring freeze and it’s unfortunate to see that critical projects that need new engineers are not able to even interview a new employee, and thus, the engineers who are on the project are asked to take on a heavier workload and meet specific deadlines. Just as Luisa said, my company also hires many contractors to meet the needs of the projects. These contractors are only allowed to stay in the company for a maximum of 15 months, and once it is over, managers are allowed to bring in new contractors. It’s a cycle, and an unfortunate one indeed because training has to constantly occur, and every new contractor has to become familiar with the product itself. However, at the end of the day, projects are becoming successful with the help of these adequate resources, while maintaining budget requirements of the R&D department. It’s a win-win.

I agree with Luisa, this situation makes room for contractors to be hired as it is easier to hire and terminate and less costly than a company employee. This is why timelines on the PM side are so important as usually these contractors will be hired in the beginning phase of the project so that they can be trained and well adjusted before the project actually starts.

Sometimes, presenting numbers isn't the effective way to communicate the need for more resources, for instance budget. By taking the focus away from numbers, one can present how the objective meets the company goals. You can even sometimes link it to their mission or vision. This way the budget can be presented in a broader context and may strike a chord in the key stakeholders. One can highlight the major areas where budget/resources are being allocated and if it is productive. There are always many areas in the company where budget is allocated but that department is not meant to produce results. One can display the need for resources for their objective by comparing it to areas where as many resources are not required.

I believe the above comments are solutions from the business/company admin side. To answer Fady's question from the employee perspective, I believe the best way to communicate to management that additional resources are needed is to speak up management have to deal with constant budget cuts. A better management would have some plans for this but in cases where certain tasks/procedures happen unexpectedly, an employee should be honest about the current insurmountable workload, discuss the job duties, outline the obstacles/difficulties, and outline a new hire's potential responsibilities. After that, the management can decide whether to hire a contractor or a new person. Overall, if the workload is too much for a team/employee constantly, the productivity will reduce or the employee may even quit the job.

I think management should already have a good understanding of the resources needed to uphold their QSR. As we learned this week in lecture Management oversees the subsystems: i. Design Controls, ii. Corrective and Preventative Actions, iii. Production and Process Controls, iv. Equipment and Facility Controls, v. Records Documents and Change Controls and vi. Material Controls. Therefore there should be regular/clear communication with management between the subsystems and management. We also learned that if companies do not follow the device regulations, if found that the device does not comply, it is considered "adulterated". This means that the devices and people responsible for this are subject to regulatory action, and could even receive jail time. I these are serious consequences that should not be taken lightly. Therefore, I don't think management would want have quality suffer to save resources. It could ended up costing them everything in the end if it is not compliant with current regulations. I think they would be happy to discuss to make sure resources are allocated and used efficiently to ensure the development of a quality/compliant device. If resources are really going to be cut, as @thuytienlecao mentions good management would have some plans to address these cases, but if appropriate actions aren't being taken-I think you would just need to communicate your concerns and solutions to management. Communication is key and QS are important.

From my experience in the industry, this is a common problem in many departments. I’ve seen departments over loaded with work and the quality of the work that they are able to accomplish decreases. Sometimes people feel rushed and make mistakes. Sometimes people may try to cut corners.
Additionally when teams are over loaded with work and require more resources, employees begin to just go through the motions to get things done instead of continuously looking for ways to improve the process or product. I think the first thing that employees must do in this situation is to ask for help. Many employees are afraid to raise additional resource concerns because they fear that they will be labeled as unproductive. I also think that the most effective way to ask for additional resources is to approach the situation objectively. Instead of just saying you are overworked, I suggest presenting the benefits of additionally resources and potential consequences if the situation does not change.
Some suggestions include:
• lay out your priorities and identify what has been put on the backburner
• outline activities completed in a typical day/week.
• quantify the time required for each of your projects
• be honest and upfront if you have fears that something will fall through the cracks

With management, it is important to be open to communication while still maintaining a high level of respect. It is possible that since management is so far removed from the lower levels of the chain, they are blind to the intrinsic problems that occur. By enlightening management to what is needed from the engineering perspective, the QMS as a whole can be improved upon as a team. It is also important to listen to management's viewpoint because there is a reason they may not have implemented a certain change that was proposed.

I think kak33 gave a very good explanation of an effective way to bring up this topic with management. An employee needs to take the initiative to write out exactly why they think that additional headcount is needed. Like kak33 mentioned, if they have a detailed log of their day to day activities, highlighting tasks that they are unable to complete, and explain exactly what the resource is needed for, it will carry much more weight than just going to your manager and saying you need more resources because you feel overworked. From my experience, facts are essential for having these conversations, and not only that, but if you clearly describe the problem, show how it is impacting the project, and propose a logical solution, it will make your manager much more likely to act and get the additional resources that are needed.

This is a very good observation. Contracting employees has long been a solution for big medical device companies to control budget constraints. The way this usually works is a big project comes along for a specific department. The department director will have a set budget for the year. When additional resources are needed they will reach out to a 3rd party and tell them here is 80k to find us an Engineer. The 3rd party will post this job and offer the potential contracting Engineering 60k and the 3rd party will pocket that 20k difference. In most cases, it will be an hourly rate and not a salary rate for legal and benefit reasons. The hiring of contractors doesn't exactly correlate to a decrease in quality but it can if the company continues to hire inexperienced contractors. If additional resources are needed, the best approach is to reach out to the director and explain to him/her why an additional employee is needed and explain whether this additional employee is needed based on a project or for the overall benefit of the team.