Quality Assurance is a way of preventing mistakes and issues within manufacturing environments. Describe ways to prevent and ensure manufacturing safety. In addition look up a issue that has happened in manufacturing environments and add solutions for an issues that has occurred.
The cleanliness of your workspace can assist in preventing and ensuring manufacturing safety. An increase in errors and injuries can result from not cleaning up. The cleanliness of your workplace should always be a top priority. Cleanliness standards should be clearly posted in an accessible location to all employees, and regular cleaning tasks should be delegated to employees. If necessary, cleaning professionals should be engaged to keep the workspace neat and clean. This process can only be executed successfully if managers possess sufficient delegation, leadership, and communication skills. You can begin by ensuring that you have proper management training systems in place, as well as making sure that all managers are focused and attentive. You should also conduct unscheduled equipment use tests as part of your role as a manager for safety. A random group of employees will be asked how they use all relevant machines during an unscheduled equipment use test. Make sure they follow safety measures closely throughout the process, as these are often the weakest and must be improved the most. A workplace serious about improving its quality control measures and ensuring the safety and efficiency of its workers must conduct this testing. While it may seem like a nitpicky detail, it is crucial.
Quality assurance has to do with developing guidelines to ensure optimal performance of a device. Within this branch of a company, employees are able to closely monitor the progress of a device and tweak the system/procedure. As a result, one way to ensure manufacturing safety and prevent decreased quality of a device is to make these guidelines as detailed and clear as possible so that all departments appropriately check their deliverables. In addition to being detailed, these guidelines should contain the most updated and accepted quality tests to ensure that the quality of deliverables is up to current standards. I also agree with what @mayasaunders mentioned above. Organized instructions and a clean workspace is essential to ensure device quality. Confusing procedures lead to confusing results since employees are more likely to get lost during quality control. A clean workspace reduces clutter, which ultimately allows employees to work more efficiently and produce better deliverables.
An example of a device that encountered issues caused by the lack of quality control was the Zimmer Biomet spinal fusion stimulator. During routine monitoring, two of these devices presented high levels of chemicals that could have been toxic to neighboring tissues within the body. This is clearly an example of the lack of quality control because the chemicals were not found in every device. As a result, some products from this company were recalled and reviewed for improvements. If all products were appropriately checked, the recall could have been prevented.
One of the biggest ways to ensure manufacturing safety is to ensure a clean area and workspace. In this way it makes it easier to find necessary materials and ensures that there are no loose or misplaced items that could injure someone. Another way to ensure safety is to do regular inspections on machinery used. This would ensure that the machines are up to par and have no potential hazards in broken pieces or electrical components. This could also ensure quality by making sure that the machines are routinely calibrated for the most accurate usage. One issue that happens in manufacturing environments is the constant changing/updating of regulations and standards. As more information is present standards can change to accommodate them so a solution to this would be to assign a person to keep up to date on regulations. It would be their job to ensure that the jobs are being done to the standards met as well as if any new changes arise, they would need to be able to present and have them assimilated smoothly.
Quality assurance ensures the product is safe, potent and pure meeting all necessary attributes laid down by regulatory agencies. Keeping procedures transperant will help help improving QA. It involves process to educate the staff involved, direct and indirect customer about changes in guidelines, data and manufacturing procedure whenever required. Another way to improve QA is by using minimising human interference and maximizing automation in manufacturing. It will prevent any possible error regarding process checks, production record review.
In the commodity chemical industry, workers safety and quality control have a lot of overlap. A lot of instrumentation, particularly reagent measurement, can have Safety Critical and Quality Critical designations. This means the observation, maintenance, and reporting by the device is scrutinized under two very common management systems within a company. An example of a measurement device that has implications on both would be a gas analyzer for an Ethylene Oxide sterilization chamber. Cavalier management and/or tolerance for inaccuracy would have severe implications for worker safety, as underreporting of EO within the chamber can expose the workers to toxic doses of EO. Likewise, overreporting of EO can inadequately decontaminate the device, leading to entire batches of contaminated products.
An example of limited quality control leading to a recall would be the Eco-Med Ultrasound Gel recall in 2021 (link below). Bacterial contamination led to the recall of 8 lots of gel. The root cause was not published but based on experiences I have had with contamination could be improper dosing of decontamination media (UV light, EO, etc.), failed filtration, and/or sloppy industrial hygiene practices.
Quality Assurance is a way of preventing mistakes and issues within manufacturing environments. Describe ways to prevent and ensure manufacturing safety. In addition look up a issue that has happened in manufacturing environments and add solutions for an issues that has occurred.
The company gives the quality assurance employee a checklist of different criteria. If it passes all the criteria, it is released to the market, but if it does not, it is either sent back to be fixed or thrown out altogether. Organization is vital to quality assurance because it can lead to sloppy work and terrible outcomes, especially when working with products that will go into humans like a pacemaker. Faulty product design is one of the main reasons why medical devices go out of business. Quality assurance personnel should ensure defective devices do not go into the market since they can cause severe patient complications and significant problems with the company you work for (ex: lawsuits). The overall key to ensure no faulty devices go onto the market is organization and a checklist to ensure all products work correctly.
To further add on to what @mayasaunders mentioned, cleanliness in the production area is especially important when manufacturing sterile devices that make direct contact with patient tissue and/or blood. These products have strict requirements regarding the environment in which they are manufactured to ensure that no potentially harmful debris or bacteria can enter the patient. The degree of cleanliness that is necessary to maintain depends on the device's intended use, risk level, and whether it is Class I, II or III. ISO defines varying levels of cleanroom classifications, ranging from ISO 1 to ISO 9, with 1 being the most clean and 9 being the least. The cleanroom is maintained using a robust filtration system, and the air must be regularly sampled for particles. The cleaner the cleanroom, the smaller the allowable particle concentration.
Source: https://www.linkedin.com/pulse/understanding-cleanroom-classifications-iso-8-7-6-5-charles-lipeles/
To prevent errors in manufacturing, it's crucial for each person along the production line acts as a checkpoint for their deliverables and those preceding. The implementation of these "quality checkpoints" during the manufacturing process will ensure all components of the product are complete. It is also important to make sure that each role of the production line is well defined and provides detailed procedures and what to do in cases where troubleshooting is needed. To ensure safety, I think that organization, cleanliness, and instrument maintenance may be leading contributors. A clean and organized workspace will decrease the risk of errors and injury and performing maintenance on the instruments will prevent instrument errors.
I think the ways of ensuring manufacturing safety are very similar to the rules we have in place in the lab that I work in. Using equipment, machines, and tools properly is important because many of these are heavy machinery that can inflict severe permanent damage to the user if they are not using it correctly and safely. To avoid this issue, reading through and understanding the user manual is important before using heavy machinery and general devices. Also training, especially for heavy machinery, will be useful to determine if a user is properly equipped with the knowledge to handle using it properly and safely. Wearing PPE is very important, especially in lab environment where a person could be in close proximity to biological hazards and chemicals. Having clean workspaces is a key factor in ensuring safety amongst workers since messy environments tend to pose the risk of people falling and/or becoming exposed to hazardous chemicals or biological waste. However, I would say that the biggest component in improving safety in manufacturing environments is communication. If something looks off or wrong, it should be immediately notified by a supervisor or manager. Even if it ends up not being a severe issue, it is important to be aware of your surroundings in case a severe risk in the environment you are working in appears. It is also important for supervisors or managers to take care of highlighted issues promptly so that employees are not at risk of harming themselves. If present and potential issues are communicated, then manufacturing environments will be much safer.
A corporation will build and manage a quality assurance (QA) system to make sure that the products and services it offers are of a continuously high standard and adhere to legal and organizational requirements. QA supports employees in achieving quality goals for each product or service provided. Defects in a product are some of the common issues that are seen in manufacturing, and they can be minimized by performing a few additional steps to save a company time, money, and consumer retention. Auditing the supplier's quality management system can ensure that products are being made with the highest quality materials and according to the SOP. Procedures within the quality management system that are checked are quality records, handling and storage, production and process control, training, and purchasing to name a few.
A few ways to prevent and ensure manufacturing safety first and foremost are to wear proper PPE, make sure to follow the safety protocols, understand the emergency response plan, be aware of the safety regulations, and have seamless communication. The majority of accidents occur as a result of inadequate or inconsistent staff training, a lack of guards and safety equipment, or compromised safety. Manufacturing plant workplace safety is attainable if you are aware of the various sources of safety dangers and how to avoid them. An efficient risk assessment can help you keep track of the dangers in your facility and provide insight into the equipment maintenance and repairs that are required.
Manufacturing safety becomes a second thought often during manufacturing because many companies are concerned with profit and how much they can make. Having the safety-approved equipment becomes less important because there isn't a disaster or worst-case scenario where companies aren't concerned, and the fact that this equipment becomes expensive is not at the forefront of the company's concerns. One of the scenarios that comes to mind is Bhopal's safety incident, where many safety issues were pushed to the side and a chemical runaway reaction occurred due to safety negligence. The company had a series of warnings from different organizations about these safety issues, ranging from the safety alarms to things such as not having an adequate safety system in place. Several solutions that could've been in place were to have a better safety system, conduct safety observations, and hire people to investigate issues with alarms that were ignored, among others. In this incident, quality assurance was lacking, despite the fact that this company was not ignorant of the issues that were occurring on a daily basis but chose to ignore them. By ignoring these issues in the manufacturing environment, water had leaked into a storage tank, which shouldn't have led to disasterous results. People to this day mention the incident in safety classes for engineering. If this company had a better safety culture as well as a quality assurance team, then these issues could've been resolved.
Preventing mistakes and ensuring safety in manufacturing environments is critical for maintaining quality, regulatory compliance, and worker safety. One important way to ensure manufacturing safety is through conducting comprehensive training programs for employees. Employee training is critical to manufacturing safety because well-trained workers are the first line of defense in preventing accidents and maintaining compliance. To start, employees need to fully understand the machinery, safety protocols, and procedures they need to follow. Lack of knowledge or improper handling of equipment is one of the most common causes of workplace accidents. When employees are trained on standard operating procedures, they are better equipped to follow the correct steps, ensuring uniformity and avoiding process deviations that could lead to accidents or defects. Furthermore, manufacturing environments tend to have extremely strict safety regulations, where non-compliance can result in legal action. This means that employees should also receive up-to-date training that updates them on the latest regulatory changes and company policies that are related to safety.
An instance in which a lack of employee training led to a serious issue would be the Deepwater Horizon Oil Spill that occurred in 2010. In this scenario, there was an insufficient amount of training on the equipment used to manage the well pressure. Workers lacked comprehensive knowledge of the blowout preventer, which failed during the crisis, leading to one of the worst environmental disasters. As a result, there was an industry-wide push for improving employee training on equipment and safety prevention.
One of the key ways to ensure manufacturing safety is by having a clean and organized workspace. This helps locate the necessary materials easily and prevents the loose or misplaced items that could cause injuries. Regular machinery inspections are also very essential for safety, as they help identify any potential hazards. Routine calibration of machines further ensures quality by providing accurate and reliable performance. In manufacturing, the frequent updating of regulations and standards can be challenging. To address this, assigning a person responsible for staying current on regulations can help ensure compliance. Their role would include ensuring that work meets the required standards and smoothly integrating any new changes as they arise.
