Recently, Augmentir completed a rigorous qualification audit as part of a Tier 1 Pharmaceutical Manufacturing company’s Good Manufacturing Practice (GMP), and we are pleased to announce that our product successfully passed the audit.
Recently, Augmentir completed a rigorous vendor qualification audit as part of a Tier 1 Pharmaceutical Manufacturing company’s Good Manufacturing Practice (GMP), and we are pleased to announce that our product successfully passed the audit.
According to the International Society for Pharmaceutical Engineering, GMP regulations require that pharmaceutical manufacturers adequately control manufacturing operations, and establish a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. The use of Augmentir’s connected worker software is a critical component for manufacturing within the pharmaceutical and life sciences environment as it helps to reduce errors and ensures compliance with these regulations.
This qualification audit, performed by our client’s Lead Auditor and the Senior QA Validation Specialist, assessed the adequacy and effectiveness for adherence and compliance to regulatory requirements. The quality and effectiveness and compliance to the site’s Quality Management System (QMS), policies, and procedures were also assessed and ultimately, Augmentir was approved to be an Enterprise IT System/Infrastructure Provider.
Audits like these are challenging for any company and can present even greater challenges for small companies like Augmentir. Yet, it is extremely important as GMP regulations ensure a quality approach to manufacturing, helping companies minimize errors, mistakes, and instances of contamination.
At Augmentir, we have successfully completed multiple audits to date and are excited to add this Pharmaceutical GMP Audit to that list as we continue in the steps of our legacy products. These audits aren’t new to our team, and this recent milestone is a continuation of our history in bringing innovative, high-quality software into the manufacturing sector, having delivered on more than an estimated 100,000 audited processes throughout the history of software products our team has been involved in.
As we kick off 2022, this Pharmaceutical GMP Audit completion stands as a testament to Augmentir, our team, and our commitment to maintaining the highest global quality standards and validates our success in the pharmaceutical industry.
Here’s to our next successful audit!
https://www.augmentir.com/wp-content/uploads/2022/01/gmp-fda-pharma-audit.png6301200Chris Kuntzhttps://www.augmentir.com/wp-content/uploads/2021/09/Augmentir_Logo_Sm-300x169.pngChris Kuntz2022-02-08 19:56:112023-03-08 20:25:20Another Successful FDA Audit in the Books
Learn how to standardize quality assurance procedures in manufacturing to improve overall quality and reduce errors.
It takes implementing just one wrong procedure for a product to end up defective and nowhere near ready for customer delivery. That’s why it’s important to standardize quality assurance (QA) procedures to ensure conformity on the shop floor and prevent product malfunctions.
But what is quality assurance? It is a process manufacturers use to determine whether a product or service meets necessary requirements for distribution. In a nutshell, QA procedures ensure customers receive quality products that are free of defects.
Learn how to standardize quality assurance procedures in manufacturing by exploring the following content:
QA procedures are a systematic process of establishing and maintaining set requirements for manufacturing reliable products and services. These procedures should be standardized by setting up a quality assurance system for workers to access. There, they can see how to complete certain tasks to avoid errors on the production floor.
Quality assurance methods can be categorized into three types, which we explain in the table below.
Type of QA method
This is the process of testing a product to see if it can withstand stress. The purpose is to identify any deficiencies.
Manufacturers may place a product under heat, pressure, or vibration to test outcomes.
Statistical process control (SPC)
SPC is an industry-standard practice for measuring and controlling product quality during the production process. Data is collected by measuring process inputs (dependent variables) in real time. This data is then transferred onto a graph with predetermined control limits based on how a type of product is expected to perform.
A manufacturing line would apply statistical and analytical tools to monitor input variables and look for excesses or waste.
Total quality management (TQM)
TQM is the idea that every employee, from assembly line workers to leadership, is committed to improving processes, products, and services.
TQM may be implemented to raise overall productivity and make a manufacturer more competitive.
How to standardize quality assurance procedures
Quality assurance procedures help manufacturers develop products and services that meet customers’ needs and expectations. If implemented successfully, QA can catch any defects before they arise and substantially increase product quality.
It’s also vital to implement a quality assurance system to improve efficiency. Developing a unified system makes it easier to incrementally improve your production processes, and it’s essential for standardizing your quality assurance procedures.
Read on about the seven steps for successful QA implementation:
Step 1: Define Organizational Goals
Successful manufacturing QA begins by identifying how workers’ jobs are tied to an organization’s goals. It’s crucial for workers to know their company’s mission and how they fit into it. When employees understand how their individual goals relate to the organization’s goals, it can boost worker confidence — and in turn, production efficiency.
Step 2: Pinpoint Necessary Success Factors
It’s important to list the factors that make your quality assurance process successful. For instance, factors can include production processes, technical or customer support, and other things that make your organization great. Creating a list of major factors that contribute to company achievements will make it easier to update and manage those factors later on.
Step 3: Identify Your Customer Base
It’s vital to define your client case. If you know your customer, you’re more likely to create products and services that they would value.
Step 4: Gather Customer Feedback
Once you’ve established your customer base, it’s vital to incorporate what they think about your products and services. Frequent customer feedback can keep your quality assurance on track since it helps you identify and resolve product issues before they become critical problems. Reports can be gathered though surveys, email, phone, focus groups, or other methods. The goal is to achieve continuous feedback regardless of which methods you choose.
Step 5: Strive for Continuous Improvement
Quality assurance goes hand in hand with continuous improvement. The information you’ve gathered from customer surveys or other methods can now be used to implement any needed changes to your quality assurance process.
Continuous improvement can also be in the form of customer service training, changes to production processes, improvements to products or services, or anything that adds value to your organization.
Whatever you do, it’s crucial to study customer comments and use them to enhance operational procedures to ensure you’re delivering products that bring value and sell.
Step 6: Find QA Management Software
Once you’ve established the above steps, it’s time to start thinking about which quality QA software, or system, will help you better implement QA procedures. Picking the right software will aid with maintaining and improving production processes.
Step 7: Assess Results
Lastly, it’s important to measure your results. Your main goal is to ensure that your business meets the needs of each customer. Create measurable objectives for employees so that everyone knows what needs to be accomplished in a timely manner. If goals aren’t met, make sure workers are clear about what actions need to be taken to meet client satisfaction.
Take note: If your manufacturing firm does not reach its goals, it is hard to show a positive ROI to stakeholders. That’s why taking corrective action to meet company targets is more imperative than ever before.
Benefits of Implementing QA Procedures in Manufacturing
Quality assurance in manufacturing can offer a wide variety of benefits if management makes it a priority.
Some benefits of standardizing QA procedures include:
Cost-effectiveness: When done right, QA can prevent quality product issues before hitting the market. For instance, manufacturers won’t have to worry about scrapped parts, product returns, or other expenses due to poor-quality goods.
Greater workplace efficiency: Manufacturers will be able to better allot resources like time, money, and warehouse space if fewer product deficiencies exist. It boils down to this: it takes fewer resources to develop quality items if processes are in place to support the feat of QA procedures.
Enhanced Customer satisfaction: Customers will almost surely receive quality products in a timely manner if workers employ quality assurance techniques. If fewer product malfunctions exist, customers are more likely to keep coming back for more. In the end, it’s a win-win situation for both businesses and clients alike.
Industrial companies use Augmentir’s breakthrough system to standardize and optimize quality assurance procedures in manufacturing. With Augmentir, you will experience fewer errors and reduced product defect rates with our connected worker solution. Learn more about our quality use cases.
Contact us for a live demo to start optimizing your frontline operations today!
https://www.augmentir.com/wp-content/uploads/2022/10/quality-assurance-procedures-manufacturing.png6301200Chris Kuntzhttps://www.augmentir.com/wp-content/uploads/2021/09/Augmentir_Logo_Sm-300x169.pngChris Kuntz2022-10-20 02:31:522023-03-07 01:31:26How to Standardize Quality Assurance Procedures in Manufacturing
Smart Skills Management software is helping manufacturers bridge the gap between training, skills, and work to build a more resilient and agile workforce.
Where are you on your journey with adopting new and emerging technologies? Many manufacturers are jumping on the bandwagon for some of the latest tools that provide digital guidance to workers. Maybe you decided to implement digital work instructions to help workers safely and efficiently perform tasks. Or maybe you’ve bought skills management software to help you catalog and organize the skills and capabilities of different workers. But are either of these enough on their own to achieve all your production goals? Possibly, but unlikely.
Digital work instructions on their own deliver standard work guidelines but fail to consider the unique skills of each worker. Standalone skills management programs may offer a highlight reel of the skills and certifications of your workers but neglect to capture performance in real-time to provide accurate skills evaluations. Nor do they offer personalized training content needed to ensure workers perform their absolute best. Can we agree then these two features should go hand-in-hand?
One cannot exist without the other: Blending skills management into the flow of work
In the past, standalone skills management systems were sufficient because:
Turnover was infrequent so line supervisors knew everyone on their team and their current skills and endorsements, making it easy for the supervisor to assign work safely and optimally
Investments in training, reskilling, and upskilling were performed either in a one size fits all approach or through a purely subjective or anecdotal approach
Today, however, a different situation exists.
Line supervisors are dealing with team members that they don’t know well, new ones starting every day, and experienced ones leaving. This creates safety issues and makes optimally assigning work difficult as not only are the workers variable, but their skill levels and certifications are a constantly moving target.
An integrated, closed-loop skills management system is the solution for this era of high workforce turnover and absenteeism.
Skills management solutions that combine skills tracking capabilities with connected worker technology and on-the-job digital guidance can deliver significant additional value. Data from actual work performance can inform workforce development initiatives allowing you to target your training, reskilling, and upskilling efforts where they have the largest impact.
It can generate an abundance of valuable data to provide tailored training support and skills endorsements and identify workforce opportunities. What else is possible? Imagine reducing training costs, optimizing job scheduling, increasing safety, and improving productivity. And now consider what will happen when you add smart technology to this all-in-one package.
The power of smart digitization! Skills management and digital work instructions together boost productivity.
Connected worker solutions that combine skills management with digital work instructions, collaboration, and knowledge management are uniquely suited to optimize today’s variable workforce. AI-generated insights are pulled from patterns identified across all work activity in real-time. These insights identify where new and experienced workers may benefit from either reskilling or upskilling.
This combination of smart digital technology can also leverage your training resources, such as instructional videos, written instructions, or access to remote experts, to deliver personalized guidance for the worker to perform their best. These tools intelligently work together to help you assign workers to procedures based on required skill levels. No second guessing! Augmentir is the only smart connected worker solution to intertwine these management tools with AI making it a powerhouse for optimizing your operations and meeting production targets.
Learn how Smart Skills Management software is helping manufacturers bridge the gap between training, skills, and work to build a more resilient and agile workforce.
Download our latest eBook – The Future of Work: Connecting Skills Management with Standard Work.
https://www.augmentir.com/wp-content/uploads/2022/09/skills-management-and-digital-work-instructions-better-together.jpg6301200Chris Kuntzhttps://www.augmentir.com/wp-content/uploads/2021/09/Augmentir_Logo_Sm-300x169.pngChris Kuntz2022-09-28 14:07:192023-03-07 01:31:15Like peanut butter and jelly, skills management and work execution are better when served together
Augmentir is the world’s only Smart Connected Worker Suite. Augmentir is being used by manufacturing and service companies to empower their frontline workers to perform at their best and deliver improvements in safety, quality, and productivity consistently, year-over-year.