How The Internet Has Changed Manufacturing https://t.co/O1bnmCKX8N
— Connie Smith (@AQMAuditing) October 29, 2019
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The term “Internet of Things”, also referred to as IoT, was coined by Kevin Ashton in 1999. This was merely one step on the long journey that has led to where we are today. Put simply, IoT refers to things, almost anything really, that can be connected to the internet and communicate. How has this hyper-connectivity changed manufacturing already and what does it mean for the future of quality management systems? Current ImplementationComputer-aided design (CAD) has allowed for a shorter timeline for a concept to go from model to prototype to manufacturing. Now, we can have machines on the production line that are connected via IoT. This allows for designs to be sent straight to production from virtually anywhere in the world. Additionally, sensors are placed in and around the machine, providing instantaneous feedback to production speed, mishaps and environmental changes. As you can connect the various machines together in your production floor, a higher level of learning becomes available. We already know that computers are better at processing huge amounts of data and analyzing trends and anomalies, so think of the powerful dashboards of information you can have at your fingertips. Prior to this, chokepoints and holdups may have seemed random; now, you will be able to visualize the impact that changes in one area will have in another, perhaps days later. This level of machine learning greatly increases the efficiency of your total production capability. Future ImplementationAs more and more devices and machines are IoT-capable, we will see a higher level of collaboration happening across supply chains. Imagine being able to know if a shipment is going to be delayed before you start the batch that will need some of those parts. We will begin to see a massive shift in the workforce. As robots and AI begin to take over manufacturing jobs, the human element will not disappear; rather, it will shift to higher levels of expertise. The current positive economy has led to an increase of manufacturing jobs, but a shortage of workers already exists to fill these jobs. Technician and programmers will be come commonplace on the production floor, ensuring smooth operation of machines rather than doing repetitive physical tasks themselves, such as packing boxes or driving screws. What Do You Need to Do?This changing landscape affects more than just the manufacturing sector. As the skills gap widens, companies need to be prepared to train and invest internally to organically grow the next generation of workers. Schools need to be preparing for this future and shifting from the old ways of education. More focus on science, technology, engineering and mathematics (STEM) is needed to prepare the next generation for the changing landscape in the world of manufacturing. A lot of unknowns still exist for manufacturing today. One thing is for sure, with the rapid progression of these changes in the manufacturing sector, the winners will be the ones who embrace the changes early and put their energy into preparing for the manufacturing of the future. As you implement your Quality Management System (QMS) under ISO 9001, you will discover that you need to document the roles and responsibilities of the QMS system. Top management must define the organizational structure, hierarchy, and lines of accountability/reporting. Human Resources personnel may assist with defining and communicating the appropriate role, duty, responsibility, and authority of each position and person. Clause 5.3 of ISO 9001 is very specific on which QMS responsibilities and authorities need to be assigned by top management. Following is a list of key assignments:
How should you document QMS roles and responsibilities?Now that you’ve identified your QMS roles and assigned them, you need to make sure you’ve communicated them in a way that can be understood. Some steps for doing that include the following:
The path to successNow that you’ve identified the roles and responsibilities for your QMS, it is key that people know who to call. Providing this documentation will ensure that the proper questions are directed to the appropriate parties and set your organization on the path to success as planned with your newly implemented Quality Management System.
from Twitter https://twitter.com/AQMAuditing As you begin implementing your AS9100D Quality System, an initial step in this process is to write your company Quality Policy. While simple, it is important to make sure appropriate steps are taken to create an effective Quality Policy. To help you tackle this potentially overwhelming task, we’ve compiled a list of tips to get you started.
As you implement your Quality Management System using ISO requirements for AS9100, you may be confused about the difference between design validation and design verification. Correctly understanding validation may be complicated, so what it is and how does it work? ISO 9001:2015 standard Clause 8.5.1 on control of production and service provision has this to say: “the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement.” This means you need to validate processes where you are unable to effectively check a product or service’s compliance to standards without damaging the part. If you are building something to a certain standard of damage resistance, it is impractical to test each part to the point of breaking to verify that it was built correctly. Therefore, you must validate the production process to ensure the appropriate steps and measures were taken in production. Process validation must represent how a process is occurring. If you try to validate in a manner different than how the process will be completed, you could run one order and find the results satisfactory while increasing the process to several hundred per day may not actually perform as expected. A simple way for validation is to set up your production process in the manner you will normally use it and start an expected run of the production process. Use regular operators, standard tooling and equipment, typical environmental conditions and normal gauges. Now that you’ve shown a process can proceed under standard conditions and doesn’t require any special requirements or attention, you are able to determine that the process will do what you need it to do. Additionally, this will identify if special skills or training is needed for a step in the process. Once identified, you will be able to create the necessary procedures for ensuring proper training is given to the operators and highlight any necessary certifications that are needed. Process validation may seem complex, but proper use of it will save your company time and money. As your processes become more reliable, you will experience less emergencies and downtime due to broken equipment, improper builds or missing parts. While AS9100 Rev D does not implicitly require every process to validated, it may be something your organization chooses to implement. Typically process validation is used in scenarios where the monitoring or measuring is not feasible or practical. Proper, detailed documentation is required for your process validation protocol. While not specifically defined under AS9100 Rev D, you should refer to documentation standards as listed under Clause 4.4.2. Identify what documented information is needed to support your process validation and operations then ensure that it is written down and communicated to appropriate parties. You also need to create documentation standards for your validation results, to ensure confidence that the appropriate steps are being followed. You may also consider including the appropriate competency requirements and records to show that all appropriate actions were taken. Using proper process validation procedures will not only benefit your organization, it will also give your customers confidence in your product, limiting the number of products that leave in nonconformance.
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About UsAmerican Quality Management is a California based auditing and consulting firm that has been helping companies maintain their ISO and AS Certifications for 25 years. More links
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