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Organizations, nowadays, need for structured approach to quality, risk and compliance management. It can be achieved by implementing right tools, systems, and teams in place. Speaking of tools and systems, technology has undoubtedly led us to a point...
Quality management is the process of ensuring that products and services meet or exceed customer expectations. It involves identifying and addressing defects, setting quality standards, and continuously improving processes to ensure quality is consis...
Automation can play a significant role in quality management by helping to ensure consistent, accurate, and efficient processes that leads to higher quality products and services for customers. Why has Automation of Quality Processes Become a Necessi...
Companies in regulated industries must have a formal process for managing corrective and preventative actions (CAPAs). Identifying problems, analyzing root causes, implementing solutions, and verifying that problems have been resolved are all part of...
Many things can go wrong in any phase of the pipeline or production, whether it is transportation to the end users or end users behaviors. Such gaps are essential to identify, as they can lead to nonconformances. What if I told you that your company ...
Each company could do better at quality management. Whatever the size of the company, improving collaboration skills and technology will likely improve quality management. Traditionally, workplace collaboration involved only in-person brainstorming a...
Efforts are being made daily to improve performance, increase profits, and enhance your competitive advantage within your organization. These efforts translate into a change initiative in process, design, and SOPs. It could be implementing technology...
Traceability is becoming increasingly important for companies in various industries. Despite some misconceptions, traceability should be part of every manufacturer process, whether food, automobiles, or aircraft. Undoubtedly, it provides significant ...
A Warning Letter (or Form-483) of Inspectional Observations from the FDA is a nightmare for regulated businesses. Receiving a list of deficiencies can feel like a heavy blow to a quality assurance system in controlled food, agriculture, and pharmaceu...
As defined by US legislation, a conflict mineral is a metal derived from one of four minerals: tantalum, tin, tungsten, or gold. Today, a small fraction of all tin, tantalum, tungsten, and gold metals are sourced from the Democratic Republic of Congo...
Businesses must prioritize customer safety at all times. Even though adverse event data is valuable for improving quality systems and processes, it can be challenging without standardized reporting standards. However, Quality professionals can minimi...
COVID-19 has changed the way we work for the rest of our lives. The possibility of remote work is available for an extended period to the entire staff in many organizations was never considered before the virus spread globally. Organizations are re-e...
Experiencing workplace incidents and its consequences is simply unpleasant. No one likes to face adverse events since they reflect that there is something wrong with the way we are handling things currently. This is where we need to be proactive. So,...
What is the Purpose of Quality Policy? Quality policies describe your company's intentions, goals, and guidelines in relation to quality. You must create one to define your company's policies that will benefit various stakeholders. Instead of just a ...
To be successful, your business needs to maintain quality at all levels. Managing an organization is about quality, how good is the product, service, process, action, or decision, and how can it be improved? An organization's success depends heavily ...
ISO and QMS: An Enterprises Perspective Businesses commonly standardize their processes. The standards in a particular field are highly distilled best practices developed by experts who understand the needs of their field. For example, a standard can...
Whether an organization succeeds or fails largely depends on the quality of its products and services. In the long run, you will not be able to survive if you ignore an important aspect like quality. Six Sigma aims to eliminate defects in processes a...
The most valuable asset to your organization is its data. First, however, you need to be sure that the data you use is reliable and trustworthy. Companies can make reckless recommendations when they work with untrustworthy data for any reason. An ind...
Training plays a critical role in creating efficient teams that help you achieve operational excellence and business goals. The benefits of building efficient teams extend way beyond. You can build a more substantial brand reputation and significantl...
The Corrective Actions and Preventive Actions (CAPA) process plays a significant role in achieving operational excellence. It increases customer satisfaction, improves product quality, and decreases risk, such as product recalls. Using the right CAPA...
Perhaps you noticed that the production team was not meeting their deadlines. Our customer complaints have been on the rise for quite some time. No matter how you slice it, something is not right about how your organization works. As a result, your t...
You may be involved in a highly regulated industry, such as medical devices, pharmaceuticals, biotechnology, or general manufacturing; companies whose control mechanisms fail to meet scientific standards cannot ensure that their testing protocols, pr...
The quality, reliability, and efficiency of the company operations and products are factors companies consider when measuring their success. Companies can improve their products and operations by measuring the effectiveness of quality management proc...
Nowadays, healthcare services are affected by three waves of intervention and change: quality management, risk management, and patient safety. Managing risk and providing quality care is essential to any healthcare organization's longevity and fina...
Organizational policies must address how, where, when, and for how long corporate, employee, and client documents are handled and stored. It's a critical compliance requirement for all types of organizations. Document retention policies are not just ...
A CAPA is a crucial component of your compliance regime. You must have an effective CAPA management system in place to manage quality issues such that they do not reoccur. However, implementing a CAPA system is just a stepping stone. The success of...
Have you ever wondered how some life sciences organizations manage their quality process so well, while others just feel stuck in aligning their processes, right? On top of it, the quality issues in the pipeline are just increasing. You are not the ...
You may be compromising the efficiency and effectiveness of your business by not prioritizing comprehensive document version control. How come? Version control prevents your employees and decision-makers from acting on outdated, incomplete, and missi...
When you are frequently reported about quality events, and many of them are recurring, it becomes difficult to prioritize them. You may find it challenging to decide which quality events require a detailed investigation. And you end up investing time...
Every organization should have a quality assurance program. Logistics companies should ensure quality assurance when implementing next-generation technologies to protect their sophisticated processes. Also, they must be able to see the entire operati...