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Managing quality is not just about reduced defects, deviations, and nonconformances. It is about the holistic approach to quality management wherein an organization evaluates every aspect from the process management to equipment calibration, supplier selection to material inspection, employee training to customer satisfaction, and identifying the ways to achieve quality, operational excellence, and compliance.

For a holistic approach, organizations need a powerful quality management system to evaluate and improve the overall processes, procedures, and systems. A QMS offers better quality control and streamlines production cycles by standardizing the quality processes. It helps unleash the maximum potential of the quality data collected and processed on a centralized platform to continuously make informed decisions, enabling organizations to continuously improve product and process quality. It also helps in achieving compliance with the applicable regulatory standards.

Another benefit you can have by implementing a quality management system is reduced quality costs. However, there are different ways a QMS helps in reducing costs and overhead expenses. We will look at 13 effective ways in this post.

1. It Standardizes the Change Implementation Cycles

One of the most common yet complex process that organizations struggle to strike a balance is change management. Despite so much discussion around the benefits of embracing change, many organizations do not have a streamlined change management process. Such organizations look at the change as a disturbance for ongoing operations. That’s where they fail at creating a culture of quality and continuous improvement.

An effective quality management software helps organizations streamline and standardize their change management processes to drive quality improvements most subtly without affecting the ongoing operations and overall organizational productivity. A QMS allows you to embrace every aspect of change that gives your business a competitive advantage over others.

In addition to the competitive edge, you are likely to save huge costs on resources required in traditional change management processes.

2. It Fosters an Environment of Learning

With the processes becoming more sophisticated and more stringent, organizations need to emphasize employee training and learning for improved performance. The traditional means of training are neither effective nor reliant when meeting ever-changing and growing customer requirements. It implies a need for an integrated training management system that can help organizations to fill the skill gap, making their employees competent for the job/tasks assigned.

A comprehensive quality management software can serve the purpose quite prominently and help organizations increase their workforce competency by streamlining the training processes. An EQMS, on integration with training management systems, can foster an environment of learning with flexible training programs for your employees, based on the job-function and department.

Therefore, you are likely to save costs of infrastructure and training materials that you used to bear

3. It Streamlines the Equipment Calibration

Organizations must take good care of equipment, instruments, and other devices to ensure excellent and consistent quality outcomes. For which, they need to streamline their equipment’s calibration and maintenance activities. An integrated quality management software helps create a closed-loop quality system to efficiently manage the process, product, supplier, and equipment quality.

An EQMS helps document, track, and verify the equipment calibrations with their outcomes, demonstrating your organization’s commitment to best practices. Keeping the calibration details and certificates documented also helps meet compliance. The quality management system also gives better control to your quality managers by increasing the traceability of the tools that are due for calibration. It ensures that all the devices are within tolerance levels against the standard values defined.

Lesser will be measurement differences; lesser will be the product quality issues. Hence, you will save huge costs on product rework and recalls.

4. It Reduces the Inspection Pressure

Most companies are now preferring to reduce the pressure on inspection by handing over inspection to the production people, leaving minimal dependency on the inspection process for quality. A quality management system enables you to experiment with different types of strategies to make this move successful.

A quality management solution often helps you streamline inspection processes, based on the different aspects; for example, if there is a change in design or change in the manufacturing sources, you can simplify the inspection process in alignment with production process validation so that the change doesn’t impact the form, fit, and function of the product.

A QMS not only reduces the efforts and process cycle time for managing change; it also significantly reduces the cost of additional resources required to drive change and inspection processes the traditional way. Experience the easiest and straightforward way to handle inspection pressure with a quality management software that comes with a cost advantage.

5. It Automates the Quality Processes

Managing quality processes manually is time-consuming and tedious, especially in this rapidly evolving era of technology. Every organization needs to manage multiple functions, including CAPA, Change, Complaints, Calibration, and more, to ensure consistent product quality while embracing the continuous improvements on the go. It implies chaos of processes that can no longer be managed manually.

A quality management software solution helps streamline and automate the quality processes, reduce cycle time, and ensure faster time-to-market. It gives your quality team more control and confidence in managing the critical processes while achieving operational and compliance excellence.

Automating the quality processes reduces the chances of errors and frequency of customer complaints to protect your brand reputation, which can cost you the business.

6. It Offers Greater Control of Processes

Process control is essential to ensure the organization’s operational excellence, which increases profitability, provides quality, and ensures safety. Proper process controls are necessary to maintain product quality. But they cannot be managed to utilize traditional tools and techniques anymore.

Quality management software is the need of the hour. It helps organizations to ensure process controls in place to avoid quality failures. Process controls allow control errors that could lead to a catastrophic event or life risk. A QMS creates a closed-loop system of quality processes with proper authorities at every production stage, ensuring superior product quality every time.

There will be fewer errors and failures; you will be spending lesser money to fix the same.

7. It Improves the Supplier Relationships

The organization depends on the suppliers for the critical assemblies. They need enough time to evaluate the suppliers on different criteria to create their approved supplier list to assign essential jobs without worrying. Supplier selection done right helps ensure the required attention is given in every product’s case. There are many other concerns associated with supplier selection, including costs, efficiency, timeliness, and more that cannot be managed with traditional spreadsheets.

A powerful quality management software is required that can help manage the supplier-related processes as efficiently as other processes. It enables organizations to improve collaboration and communication with the suppliers, encouraging them for better performance.

Supplier-related processes managed right reduces the risks involved while lowering the cost incurred due to inferior quality materials.

8. It Reduces the Costs of Quality Failures

The costs of quality failures often lead to more significant troubles for the organizations, including increased costs and a threat to the reputation. It cannot be managed using the traditional reactive approach to risks wherein you spend more on the issue. It’s high time for organizations to take a proactive approach as well. It will help prevent the quality issue before it leads to any unfortunate event.

A quality management solution enables organizations to take a proactive approach to risk management while keeping them prepared with a reactive approach, too, for unexpected events.

9. It Reduces the Documentation Costs

Whether you want to file a nonconformance report or wish to update new versions of the document, the traditional document management system will burden you with massive costs. Moreover, you will face the visibility and traceability issues due to dispersed data.

The advanced quality management software seamlessly integrates with the cloud-based document management software to manage all the documentation related tasks from creation to approval, version control to publishing, and making it obsolete. It also improves the quality data’s visibility and traceability, allowing organizations to meet compliance with eSignature validation.

Therefore, you can save a considerable amount of costs for managing documents in a paperless, hassle-free, and timely manner.

10. It Improves Task Routing

The costs of routing the critical tasks are quite underrated in the organizations. For example, – you have created a workflow process across multiple departments. And, it involves all the members in every phase/discrepancy. It will impact the productivity of the people who are not even needed.

Quality management software helps configure the process workflow while limiting the participants in each discrepancy according to the need, by adjusting the workflows for different types of issues with different escalation process, ensuring the best use of your team members’ time.

11. It Manages the Redundant Tasks Efficiently

Organizations often invest time, resources, and costs in managing repetitive tasks. They need to streamline such tasks to reduce the process cycle time and increase the cost-effectiveness. The best solution is compliance-driven quality management software.

An Enterprise Quality Management Solution helps meet your quality, compliance, and regulatory requirements by leveraging Industry best practices with standardized, repeatable processes through easy-to-configure predefined workflow templates. The cloud-based quality systems generally possess an integrated design that connects all the QMS processes for a complete solution.

Isn’t QMS a simplified and straightforward approach to quality and compliance management within minimal costs.

12. It Helps Managing Reworks Effectively

Rework is something that no company wants to deal with. But they need to. Managing rework brings multiple benefits to the organization, including a smoother supply chain, consistent quality products, and much more. Managing rework and associated responsibilities may be too much to handle, so implementing a quality management system is a wise choice.

A quality management system helps companies tackle errors and problems more efficiently while saving time and money.

13. It Leverages Advanced Reporting and Analysis Tools

Reporting and analysis are quite underrated when it comes to leveraging the potential of collected data. A thorough analysis of trends helps you understand what’s working and what’s not to take the business decisions accordingly. Through reporting, you can share the analysis, trend behaviors, action plan(s), and many other things to the involved parties in a simplified manner.

The next-generation quality management system comes with advanced reporting and analysis tools to help make informed decisions, reduce rework and other overhead expenses.

All the points mentioned above outline that a quality management system helps to reduce the costs of quality in a compliant, timely, and efficient manner.

The Bottom Line

Organizations are always struggling to figure out the difference between the costs they spend on preventing failures versus the amount they spend on fixing the failures. The traditional ways of reducing quality are no longer efficient. It’s time that organizations adopt the next-generation enterprise quality management software like Qualityze EQMS Suite and reduce the quality costs more efficiently than ever.

With an integrated EQMS software, organizations can build quality of culture and compliance wherein everyone will be responsible for quality at their ends. The production will be more about smiles and lesser stress for everyone. Giving ownership to your workforce will make them more confident while keeping them engaged in the core activities.

Quality management software is indeed a worthy investment for holistic improvements.

If you want to know more about the role of QMS in reducing the costs of quality, you can get in touch with the customer success team of Qualityze, and we will be right there for you.

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The role of equipment, devices, and instruments to produce a quality product is undeniably crucial for every manufacturing company. It becomes even more important to assure the quality of measurements of such devices through regular calibration both before and after the use of the equipment. It improves the traceability of equipment measurement accuracy if it is under the standard value limit.

In the era of technological advancements, precision is the requirement of increased importance. From power supplies to multimeters, signal generators to signal analyzers, all the equipment need pre and post measurement calibration to ensure the accurate results. Regular calibration often demonstrates that the company is taking its responsibility of delivery superior quality products seriously and making every effort to achieve customer satisfaction.

What are Standards Applicable for Calibration?

• ISO/IEC 17025: 2005 General Requirements for the Competence of Testing and Calibration Laboratories
• ISO/IEC Guide 98-3:2008 Guide for Expression of Uncertainty of Measurements
• ILAC-G8:03/2009 Guidelines on Assessment and Reporting of Compliance with Specification
• ILAC-P14:01/2013 Policy for Uncertainty in Calibration
• ANSI/NCSL Z540-1-1994 Rescinded 2007, but still in regular use for existing Aero/defense work
• ANSI/NCSL Z540.3-2006 Requirements for the calibration of Measuring and Test Equipment
• ISO 9001:2015 Quality management systems – requirements

When Equipment Calibration is Done?

• Equipment calibration is usually done whenever you want to;
• Verify the accuracy of new instruments and equipment
• Verify the equipment accuracy after its maintenance or repair
• Conduct periodic check of the equipment measurement accuracy
• Verify equipment measurements against the specifications especially when the other equipment is dependent on the core equipment
• Ensure equipment accuracy for smooth application
• Ensure equipment’s smooth functioning after it is due for calibration or maintenance.
• Stabilize the equipment functionality against the effects of shock or any other adverse conditions
• Lower the impact of the environmental changes on equipment measuring capacity, such as severe weather changes.

Benefits of Equipment Calibration for the product time-to-market or production yield

It Maintains Process Safety

In the manufacturing industry, it is important to measure component precisely to ensure product quality since it could lead to a safety risk. For example, if an equipment will not measure the right quantity of chemicals, it could lead to excess heat generation and equipment failure. It could pose life-risk to the site-workers. It will also impact all the other processes in the pipeline and will delay the time-to-market.

On the other hand, if the equipment gets calibrated regularly, you will be aware of inaccurate measurements before any major issue surfaces. Accordingly, you can escalate the issue for further investigation and effective resolution. Timely equipment calibration activities could save you from unnecessary delays in the routine processes, time to market, and correction.

However, it is bit tricky to manage calibration activity of multiple assets and equipment especially for geographically dispersed units. You can count on the cloud-based calibration management software for efficiently managing equipment calibration activities anywhere across the globe.

It Reduce Manufacturing Costs and Quality Failures

Product defects, deviations, nonconformances, or noncompliance – whatever you call it, a single issue can deteriorate the product quality. It can turn into losses for the organization in terms of money, time, and resources you may need for managing rework and product recalls. And, imagine all this just because of minor measurement differences.

Frustrating enough, right?

Calibration can save you from all these without any hassles. It will ensure that all your equipment is working fine and measuring accurately against the standard values, reducing the chances of errors and product defects. It further helps reducing manufacturing costs and quality failures. Therefore, Regular calibration activity gives you more control and confidence about your equipment and the products manufactured, reducing the rework and failure costs.

Make sure you don’t take a traditional approach to manage, schedule, and track the equipment calibrations wherein you have higher chances to miss equipment calibration. Go for a powerful calibration management software that can help you manage calibration activities for a bigger lot/batch of equipment efficiently.

It Ensures Consistent Product Quality

Any equipment must be monitored and maintained regularly to perform at its best capacity, efficiency, and quality. Even the most minor differences can result into major quality issues in the product, which further leads to customer disappointment and damage to the brand reputation. You can further face reduced sales, wastage of time and resources, and other problems.

Calibration ensures every product manufactured comply with the company’s internal specifications and applicable regulatory standards. Monitoring and maintaining equipment accuracy regularly will keep your production optimum and product quality consistent without any disruptions.

To maintain and monitor equipment without fail requires you to be proactive with your efforts. The best way to make a proactive approach is to invest in a compliance-friendly and powerful calibration management software. It will allow you to schedule equipment monitoring and will automatically send alerts before the calibration is due. Isn’t that every manufacturing company needs to ensure consistent product quality?

It Helps Meet Compliance and Achieve Certification

When it comes to meeting compliance, your equipment must measure accurately against the specified values. This demonstrate you as a reliable organization that values quality the most. More accurate will be the measurements of the equipment; easier for you to meet and maintain compliance with applicable regulatory standards.

Calibration ensures that your equipment and devices are maintained on a regular basis. You can be confident of your processes and equipment working well every time you face a regulatory inspection or an audit for equipment, processes, people, and quality systems. To put simple, calibration helps meet compliance and achieve certification.

Whether it is about quality assurance, asset tracking, or turnaround time, all the calibration activities must be carried efficiently to avoid major failures. The best solution here is a calibration management software that can help perform all the calibration related activities from accuracy check to maintaining records, and escalating issues to NCR system. Right calibration software can help your organization stay compliant and achieve regular certification from regulatory authorities within minimal efforts.

It Ensures Customer and Employee Safety

When your instruments and measurement devices work fine, you can be confident of producing quality goods to the customer, ensuring complete safety. Additionally, you can ensure the employee safety too. All equipment meeting standards specifications will reduce the chances of failure or workplace incidents, keeping your employees completely safe.

You can implement a calibration management software to manage calibration records of all the equipment, regardless of their geographical location. Safety and quality are a wide-spread notion and it must be there at all costs.

It Maintains Brand Reputation

Now that we have talked about all the other aspects of performing calibration, it will not be wrong to say that equipment calibration ensures consistent quality, which eventually helps maintain the brand reputation at a global level.

You must remember that calibration is an activity to be performed on regular basis. Missing on calibration implies impact on the process quality, product quality, customer satisfaction, and eventually brand reputation.

However, using a robust calibration management software can help maintaining everything under a single system including calibration schedule management, document management, regulatory reporting, asset/criteria creation, and much more without any hassles.

Hope you understood the close connection between calibration and quality management. You can make most of this connection if only you take the right approach and right tools.

The most appropriate tool here would be a comprehensive enterprise quality management software that can help establish a closed-loop system to manage all the quality processes in a streamlined and standardized manner. One such solution is Qualityze EQMS Suite – set of ten powerful modules.

Qualityze Calibration Management Software allows organizations to manage their critical assets by streamlining calibration programs while complying with regulatory requirements. It can be seamlessly integrated with existing quality management systems to effectively and efficiently leverage single- and multi-site calibrations.

With Qualityze Calibration Management, you can;

• Create Asset and Criteria Library
• Manage Calibration Schedules
• Perform Scheduled/Unscheduled Calibration
• Get Improved Visibility of Equipment Performance
• Leverage More Traceability of Calibration Records
• Integrate Calibration System with Nonconformance Management System
• Integrate with Existing Business Systems
• Controlled Calibration Records and Data

Doesn’t Qualityze sounds like a comprehensive solution to manage all your calibration activities?

To know more about the Qualityze calibration management software, you can get in touch with the Qualityze Customer Success Team on 1-877-207-8616 or write to us at info@qualityze.com, and we will be right there for you.

Many of the manufacturing companies are still trying to manage their operations and processes as per fourth industrial revolution i.e. Industry 4.0, overcoming the challenges on the way. And, the next industrial revolution has already been announced i.e. Industry 5.0.  

If the fourth revolution was focusing on transforming the traditional factories into IoT-integrated smart facilities that can leverage the benefits of cognitive computing while interconnecting on cloud servers, Industry 5.0 is set to divert the focus on human intervention into the industrial framework. 

What is Industry 5.0? 

Industry 5.0 is, undoubtedly the future, but already gained traction due to the change of processes associated with it. It is focusing on bringing man and machine in closer cooperation to improve products’ quality while making a systematic approach towards the prevention of industrial wastage, especially the waste arising due to industrial upcycling. 

The priority with Industry 5.0 is to create a synergy environment wherein the workforce of man and machines can be effectively utilized to improve the methodologies and efficiency of production. It won’t be wrong to say that it will bring the manufacturing companies back to reality than working through the virtual environment. For the manufacturers who have already started using advanced technologies like IoT, there isn’t an instant need for firing their workforces and become completely dependent on AI. 

In fact, Industry 5.0 is expected to trigger greater advances in the manufacturing industry, which will infuse newer levels of speed and perfection. Moreover, this industrial revolution is beneficial for the environment as well since companies will look forward to the implementation of renewable energy while eliminating unnecessary resources. 

On an all, Industry 5.0 is about the full realization of the architects in creating a positive working relationship in the industrial environment. 

Role of Industry 5.0 In Bringing Humans and Manufacturing Design Process Closer 

Industry 5.0 is introduced to make us realize the potential of working in a closed-loop wherein we can push the design boundaries with the inclusion of physics. For example, if you want to design the next-generation automobile, you will have certain limitations in your way let say the manufacturing capabilities, the amount of data available to you, and also your ability to utilize that data into your design process.  

Industry 5.0 gives you the ability to process automation in manufacturing, implying that you will be getting the real-time data for the analysis.  

How Does Industry 5.0 Matters for Human Workforce? 

As you shift from the fourth industrial revolution 4.0 to Industry 5.0, you will tend to create high-value jobs than earlier since you are handing the design responsibility back to the human hands. 

Even recent research demonstrated that the workplace will not become small by bringing humans closer to technology with respect to manufacturing; it tends to grow. The human workforce takes work with much more responsibility. As a result, you will develop a bigger yet healthier work environment, which is safer in real terms. 

You can now involve humans in the design process rather than manufacturing, which is automated to a large extent. It infuses more freedom from the physical labor while enabling you to create products that are personalized and reflect excellence too. 

Major Benefits of Shifting to Industry 5.0 

There are numerous benefits of shifting to the newest revolution Industry 5.0 for the manufacturing companies. Some of them are: 

1. Personalization will replace mass production 

With the inclusion of Industry 4.0, manufacturers got an enhanced ability to mass-produce the products. But it’s still not the perfect thing. The reason is freedom of personalization that it took away from the humans. Let say if you have something unique in your mind regarding your car design to make it look from the rest, you cannot expect it through automation. It requires human intervention at least at the design level in order to give automated machines the right instructions to manufacture the car customized per your needs – in terms of looks as well as functionality. You can also take improvisation to the next level by integrating a quality management system in your current processes. 

2. Technology will be dominated by psychology 

Though there are many products that don’t need human touch and Industry 4.0 looks perfect solution for them. But the costs will be relatively higher. There are many products including engine block that can be made by humans in a low-lighted factory will save huge costs not only to the manufacturer but also to the buyer since none of them will have to bear additional costs of high-level machine production. And, think of the number of jobs such kind of production saves. This is what exactly outlined in Industry 5.0. Thinking of all the aspects and still ensuring premium products requires human intervention, which Industry 5.0 has brought back. 

3. The human touch will regain traction 

Customers today are ready to pay the price for customized products rather than investing in something that everyone is already invested in. for example – handcrafted goods. Mass producing such products with automation is never a good idea, especially the ones reflecting local culture and craftsmanship. Using high-tech machines should be limited to the process of manufacturing, but not the designs. Human designers tend to create something unique and creative by putting their imagination and efforts, which is true personalization and often a symbol of luxury for modern buyers. They want to buy and invest in the products that reflect them or their lifestyle. This will move us back to the basics, especially in terms of design, which need the human touch to look uniquely designed. 

4. Collaborative robots will create their place 

Collaborative robots are effective tools that companies need to withstand Industry 5.0 and the return of the human touch. The collaborative robots are designed to take human craftsmanship to the next level – in terms of accuracy, speed, and precision required for crafting modern-day products without losing the grace of human touch. These robots will make a perfect companion for the manufacturers shifting to Industry 5.0 like Qualityze EQMS that allows you to configure workflows based on your needs to simplify the quality management process. Better collaboration to meet the age of customizations with the human touch. 

5. Broader benefits to the marketplace

Industry 5.0 is considered a better industrial revolution than Industry 4.0. Though it is putting an end to automation, but that end connects to many other possibilities including human intervention in the design process. However, it cannot be interpreted as a complete end to automation. It is more like limiting the automation to manufacturing activities while giving consumers the freedom to purchase good and services customized as per their needs. This also allows workers to have control of their life as they will gain control of their work, unlike the fourth industrial revolution. Industry 5.0 is more like a meaningful articulation with more jobs, personalized products, automated machines, and satisfied customers. 

Are you ready for a meaningful shift to Industry 5.0? We are ready too to make your quality processes much more effective than before to withstand the challenges of the newest industrial revolution with our next-generation quality management software Qualityze.  

If you want to know more about our product and its benefits for the next industrial revolution, get in touch with our customer success team at +1-877-207-8616 or you can also write to us at info@qualityze.com. 

Let’s say you have encountered the quality issues in certain processes or products. The next obvious step is to correct the same and keep things in order.  

Okay, you did the correction and things are back in order. The real concern arises when you face the same problem in the next production/development cycle. This indicates that the corrective measures you have taken earlier were temporary. And, you need some effective actions to prevent the problem occurrences time and again. 

The key to defining the effective action plan is identifying the root cause of the problem that only a thorough root cause analysis can help you with. RCA is often the most powerful method for resolving problems. 

What Exactly the Term Root Cause Analysis Means? 

A root cause analysis is a comprehensive process employed to determine the actual cause of a problem that occurs in a product, process, system, equipment, or supplier management. It helps you examine why is there a difference between the current state and desired state. 

Root cause analysis drives the momentum for continuous improvement in a quality management system due to its primary objective of correcting the actual cause of the problem. It helps to prevent the reoccurrences of similar problems in the future. It is more like a reactive approach to a problem that has already been occurred. However, with time and experience, you can use it for developing proactive strategies to attain quality. 

Root cause analysis doesn’t strictly run on a single defined methodology. There are different techniques used. Before heading to the tools and techniques, let’s have a quick look into the approaches for problem analysis conducted at different levels of organization based on; 

• Safety  

Whereby the actual cause can be identified in accident analysis, more relevant for quality management in healthcare and automotive. 

• Production  

Whereby the actual cause can be identified during quality control practices, more relevant in industrial and general manufacturing. 

• Process  

Whereby the actual cause can be identified in the communication, more relevant in follow up and documentation process. 

• Failures 

Whereby the actual cause can be identified during engineering and maintenance, more relevant in machine and equipment. 

• Systems 

Whereby the actual cause can be identified with the fusion of any of the above-mentioned aspects. This is relevant in the risk assessment, change management system, and system analysis. 

How to Perform the Root Cause Analysis? 

The process of root cause analysis can be categorized into 7 phases that include: 

1. Establishing the Problem Statement 
2. Understanding the Problem 
3. Mind-Mapping the Problem Cause 
4. Gathering Relevant Data  
5. Analyzing the Gathered Data
6. Identifying the Root Cause
7. Eliminating the Root Cause
8. Implementing the Action Plan
9. Checking the Solution Effectiveness

Different Methodologies used for Root Cause Analysis 

Getting to the actual cause of the problem requires you to follow the above-mentioned systemic approach. However, you can use different methodologies by customizing the workflows of your CAPA management system. Some of the most commonly used methodologies of root cause analysis are: 

Pareto Chart 

Based on the Pareto principle of 80/20 (20% of the efforts brings 80% of results), a Pareto chart is a bar diagram that in combination with line graph represents the frequency of problems with their significance. It is suitable for tackling the problems with multiple potential causes that you can arrange in the order of most important to the less important.  

The 5 Whys 

Next in the row comes – The 5 Whys. It is the most recommended methods of root cause analysis that doesn’t require you to collect data sets that reflect trends or behavior. This simple process involves asking at least 5 why question to a problem occurrence. However, you can ask more or less the number of whys until you get across the root cause(s). Isn’t it the simplest root cause analysis methodology? 

Let’s have an example here for better understanding –for an error that caused a part to be made that did not fit into the machine assembly: 

• Why did the part not fit? – The part was too small. 
• Why was the part too small? – The measurements were incorrect. 
• Why were the measurements incorrect? – The mechanical engineer did not take down the dimensions correctly. 
• Why didn’t he take down right dimensions? – Because his tools were not calibrated properly. 
• Why his tools were not calibrated properly? – Because of his ignorance. 

The corrective action is to ensure that the engineer uses the calibrated tools to take down the right dimensions to enter in the system that is used for manufacturing the parts. A manual process will be long and time-consuming.  

But you can simplify it all with the help of the CAPA Management Software like Qualityze, designed to capture the early detection of recurring problems that may result in increased expenses, resources, and a possible customers’ complaints. This eventually affects product quality and market share. 

Fishbone Diagram (Ishikawa or Cause and Effect Method) 

No matter what you call it, the fishbone diagram is a quite useful technique for performing the root cause analysis. It basically categorizes the root cause based on People, Measurements, Methods, Materials, Environment, Machines. You may use the categorization industry-wise. For example, if you are in the manufacturing industry, you will find measurements, methods, materials, machines more useful.  

If you are wondering about the name FISHBONE, it is due to the categorization and sub-causes arrangement that looks exactly like a fishbone.

Scatter Diagram 

A scatter diagram is a graphical representation that shows the relationship between the two continuous variables with one on the x-axis and another on the y-axis that impact each other. However, this relationship can be further influenced by a third variable, let’s say Z. If your scatter diagram shows a straight line, it means the variables on the X and Y axis share a stronger relationship and will get affected by each other. Sometimes, the diagram often fails to capture the relationship of two variables because of insufficient coverage of data.  

Remember that the scatter diagram is used for the analysis of the numerical data. 

Failure Mode and Effects Analysis (FMEA) 

As the name itself specifies, this root cause analysis approach focuses on identifying different factors for failure in the system. This is generally used by the manufacturing industry. It can be broadly categorized into four steps: 

1. All factors causing failure must be identified (exactly in the way any observed failure happens). 
2. How many times the same cause of failure is identified?
3. List of actions implemented to prevent the reoccurrence of the failure. 
4. Check on the effectiveness and efficiency of the actions implemented.

FMEA methodology is implemented and updated at the time of launch of new products or processes in the system, most probably at the time of change especially at the time of new regulations or after receiving customer feedback. However, you can use change management software to streamline all the changes and their relevant processes. 

Fault Tree Analysis 

Yet another effective root cause analysis approach, FTA is based on the Boolean logic to find out the real cause(s) of an unfortunate problem occurrence. This can be used for risk and safety analysis too. The fault tree represents the nonconformance/undesired outcome on the top while listing all its potential causes down the line. The arrangement of fault and the potential cause is reflected in the shape of a tree; which is why it is named as Fault Tree Analysis. 

Current Reality Tree 

This RCA approach is used to analyze the entire system at once. It is commonly used in the scenario where you need to identify the root cause of many existing problems. The listing of CRT starts from the problems at the top, and then depicting their potential causes using IF and THEN analysis. As a consequence, you will be able to find out that actual cause, which might be leading to multiple problems. 

Hence, root cause analysis is a desired process for every organization, regardless of their industry type and size. They can go with the suitable tools to identify the root causes or potential cause to implement necessary action plans effectively and efficiently.  

You can make the entire root cause analysis even simpler with the help of a CAPA management software like Qualityze. Built on Salesforce.com, it ensures flexibility, reliability, security, and scalability for your system and data.  

Stop by and contact our customer success team today to experience the Qualityze difference!  

Adhering to quality standards implies much more than maintaining the consistency of the product quality especially for the pharmaceutical manufacturers. They should consider other aspects as well including the packaging and labeling guidelines that the FDA has released to ensure that all the medical supplies reach safely to the patients. 

The quality management system for pharmaceutical manufacturers should be powerful enough to manage all the aspects of the quality of medicines as well as their packaging and labelling information. 

Why you should follow Packaging and Labeling guidelines for Pharmaceuticals? 

The quality guidelines for packaging and labeling is important to ensure that; 

1. All the medicines are protected from the external influences that can affect its curing capabilities and may have an adverse impact on the patient’s health. 
2. All the medicines are protected against all sorts of contamination.
3. All the medicines are protected against any physical harm including leakage and breakage. 
4. All the medicines carry the appropriate labels for dosage, use, and identification. 
5. All the medicines are kept safe with particular packaging material. 

The most commonly used article to store the pharmaceuticals products safely is the container. The closure also plays an important role. It should not interact chemically or physically with the contents of the container, altering their quality. There are generally four kinds of containers preferable for the pharmaceutical industry: 

1. Closed Containers 
2. Bottles 
3. Droppers
4. Remedy Kits
5. Ampoule/Vial

In addition to the medicines, the machines and medical equipment require a special type of packaging and labeling facility to ensure appropriate usage of medical supplies for quality care of patients. 

Let’s have a quick look at the proper labeling guidelines for the pharmaceutical and healthcare industry compiled from credible resources. 

1. Labelling Care 

As per the guidelines shared by FDA, all the labels to be used in the pharmaceuticals and healthcare industry should be designed and applied well so that they stick to a place without losing the legibility in the varying environments including storage, regular use, and distribution. 

It is the responsibility of the label manufacturer to ensure that the legibility of the print remains unaffected through the product life cycle. They should follow the compliance requirements for content as well as format. 

2. Show Product Information 

Every pharmaceutical product requires some specific kind of information to be displayed on the product including the product name, ingredients, the facts table, warnings, directions of use, and the allergic reactions that it can cause. 

Displaying the product information is one of the compliance requirements to be fulfilled by the pharmaceutical manufacturers to avoid any harmful reactions to the user or patients. 

3. Maintaining Label Format (For FDA) 

As we already discussed that FDA has specified an appropriate format for different pharmaceutical products including combination products, contraceptives, and other critical medicines. Some of the guidelines are –  

1. You must use legible font size and type 
2. You must use the language that’s easy-to-understand. 
3. You must take care of format especially for important information like warnings.
4. You must describe the materials if it contains products with a dropper or other types of container.

4. Selection of Right Materials 

Labelling materials are not strictly monitored in the pharmaceutical and healthcare products. You can use standard white paper to multi-layer labels based on the purpose you want the label to serve. 

Considering the safety, you can be selective with the adhesives for the labels to avoid any other substance transfer to the medicines or devices. 

5. Controlling and Inspecting Labels 

In addition to the legibility, you must ensure that the information printed on the label is correct and consistent to comply with the industry standards. it ensures safety and liability too. You must discuss the same with the label manufacturer to keep quality processes in control. 

However, you can use a supplier quality management software to ensure that you are getting only quality components from approved suppliers 

Functions to be served by Packaging 

There are four core functions to be served by packaging including: 

1. Containment 

It is one of the most basic functions that packaging serves for the medicinal products. You must consider the high-quality packaging to ensure zero product harm in manufacturing as well as the distribution system. The packaging material you use must not; 

1. Leak, diffuse, or permeate.  
2. Be weak to keep the contents safe when it comes to normal handling.
3. Change the properties of the medicine till the time of dosage.

2. Protection 

It is quite an important aspect to be considered when it comes to packaging the medicinal products. The packaging material must protect the main product from the influence of external factors such as sunlight, oxygen, moisture, contamination, or any physical damage. 

The packaging material you use must be compatible with the pharmaceutical ingredients used in manufacturing the product. Hence, protecting the product and their integrity is one of the key functions that packaging must serve. 

3. Stability  

Guidelines on the stability of the pharmaceutical products is specified. Stability and compatibility generally fall in the initial level of research and development. The selection of the packaging material should be done after careful evaluation of possible interactions between the material and the content of the container. 

The stability of the product matters to ensure that none of its properties change when it comes in contact with the packaging material. It may have a serious impact on the quality of the product. 

4. Storage 

The storage guidelines for the pharmaceutical goods are specified in the GMP guidelines to ensure safe storage for the specified time and temperature limit. For example – the normal instructions of storage that you will read on a medicinal product or drug is – “Store in a Dry and Cool Place” or “Don’t keep under direct sunlight” etc.  

Again, it is not just about storage; it is about safe storage. Make sure the packaging material you use is effective enough for safe storage. Even if there are the certain specifications, share them clearly and concisely. 

To ensure that all the packaging and labelling guidelines are properly used, you must establish a closed-loop quality management system that can help your teams to keep control of product and process quality while mitigating operational risks. It will help drive a culture of continuous improvement too. 

One of the finest ways to ensure the compliant quality system is implementing the Qualityze EQMS suite. Built on the most powerful and secure cloud platform i.e. Salesforce, it offers great flexibility, scalability, and reliability to manage processes flawlessly even if you have geographically dispersed teams. 

Let your pharmaceutical product quality control be managed through a powerful quality management system! 

Many organizations still consider the process of internal audit as an unnecessary activity without realizing the strength it gives to the foundation of the organization.

Internal audits help organizations to ensure that their business processes and product quality is consistent, allowing them to identify the loopholes and transform them into improvement opportunities. The process basically checks for the conformity of processes as well as products based on the compliance requirements.

Internal audits, unlike the external audits, may not be stringent but are significant to drive a culture of continuous improvement in the organization. The availability of the audit management software has, however, made the entire process easier.

Now you can plan, schedule, execute, and follow-up audits without putting extensive efforts, time, or money. If you really want to invest in the right audit management software, you must ensure that it helps you follow 8 effective steps for a successful Internal audit.

What are those eight steps?

1. Identify the Processes to be Audited

Auditing every single process may not be a viable thing to do for businesses. They need to identify the specific areas whose audit may help the organization to grow in real terms. For example, auditing the financial processes help organizations to ensure that their expenditure is in the right direction.

If an organization will identify the right areas to be audited, they will be making worthy efforts for success – be it planning, scheduling, preparing checklists, executing, and following up the audits. Internal audits are a wonderful tool to drive continuous improvements if used effectively and efficiently. Maintaining clarity right from the start is the core requirement to achieve the desired results.

2. Decide on the Frequency of the Audits

How often you conduct audits in your organization is an important aspect of successful audits that many organizations overlook. It also depends on the areas identified for audits. There might be some processes that require annual audit while some may require half-yearly or quarterly audits to ensure consistent results.

For example, some processes of quality control may require a daily audit while the financial processes may require audits quarterly. As mentioned earlier, there is a need for maintaining clarity about the areas to be audited so that you can make informed decisions about the frequency you need to maintain for each kind of business process. There are many software applications like Qualityze that help you maintain the frequency of every audit in an aligned manner.

3. Plan and Schedule the Audits

The next step in the queue is planning and scheduling the audits. Keeping a plan and schedule ready in advance enables you to avoid the clashes of the processes and unavailability of the right team members required for the audit. An audit plan helps your teams to plan their activities and work accordingly.

On the other hand, scheduling the audits will ensure that no single process or area left unaudited. The feature-packed software like Qualityze Audit Management System Software helps you schedule the entire audit activity in advance to ensure timely-execution, keeping the compliance and operational risks to a minimum. Hence, maintain the timeliness of your audits by planning and scheduling them in advance.

4. Notify the People Involved

It should be a common courtesy to notify all the departments about the upcoming audits so that they can stay prepared with the required documents and other materials such as evidence for the action plans implemented for the reviewer. Until and unless it’s a surprise audit on suspicious activities, your team has all the right to be informed about the organizational activities.

No department shall ever feel afraid of audits or auditors. Keeping them informed also helps develop an understanding of the value of the audit processes for the continued success of the organization. The next-generation software comes with in-built capability such as notifications so that you can inform all your employees at once.

5. Prepare the Audit Checklist and Execute Audit

Through preparing the audit checklist is an important activity of auditors, but it is quite important to ensure the right questions are asked to the right people at the right time. A checklist usually contains the process-related questions from the team members involved to ensure that everyone is on the same page when it comes to maintaining quality and brand reputation.

The good news for auditors is that there are software that comes with pre-defined audit checklists based on industry best-practices and compliance standards. You can further edit these checklists according to the practices and workflows of your organization and execute the audit.

6. Record and Analyze Audit Findings

Once the audit is performed, the next immediate thing you need to do is recording the audit findings to understand the processes working fine and the ones that require improvements. Audit findings are nothing but the insights on the quality and consistency maintained within the organization to ensure product quality.

After documenting the audit findings, you can perform analysis to identify the areas that need immediate attention versus the ones that can be reviewed and corrected after a while. However, you can efficiently perform these functions with the use of audit management software.

7. Investigate to Develop and Implement Action Plans

The improvement areas identified in the audit findings shall be investigated to determine the root cause and develop an action plan accordingly. The Investigation, Development of Action Plan, and Implementation depend on the risk severity of the issues identified.

No matter which methodology you use for the root cause investigation, make sure you perform it thoroughly since you cannot afford the recurrences of the quality issues that may lead to overhead expenses including the product rework and recalls.

8. Perform the Effectiveness Review and Audit Follow-Ups

Last but not the least, effectiveness review and audit follow-up are as important as scheduling and performing the audits since it helps you to measure the degree of effectiveness of an action plan. On the other hand, following-up work like a reminder for the audit activities that required immediate attention.

A software can that can help you perform all the eight steps with utmost ease and convenience is a worthy investment to make. You don’t need to waste time, efforts, and resources in the traditional audit practices anymore.

So, get a robust audit management software because businesses achieve success only when they maintain consistency in the product quality, process quality, and continuous improvements. A streamlined and standardized audit process ensures that compliance standards and industry best practices are followed.

Make sure you make the best of your internal audit tool to ensure you are delivering your customers’ needs every time!

Manufacturers who follow the CGMP regulations such as the pharmaceutical manufacturers need to perform process validation to ensure that all the drugs and medicinal products produced meet the quality standards as defined under 21 CFR 211.100(a) and 211.110(a). The validation cannot be effectively performed with a paper-based quality management system anymore especially when your quality teams are geographically dispersed.

It’s high time for manufacturers to consider shifting to the cloud-based quality management system for effective process validation, enabling all the quality teams to contribute regardless of their geographical location.

Why Process Validation is Important?

 Effectual process validation is significantly important for assuring the product quality – be it drugs or its ingredients. In the pharmaceutical industry, the basic principle for assuring quality is to ensure that the drug serves the intent. This principle checks for:

• Safety and quality are specifically designed within the product
• Quality assurance doesn’t merely rely on testing of product and process.
• Every single step of manufacturing is controlled to ensure that the drug is meeting all the quality requirements including attributes and specifications.

Best Approach to Process Validation

Process validation is defined as the process of gathering and evaluating data from every single stage of manufacturing, from design to final production, that works as the valid evidence for ensuring consistency in the quality of delivered products. Validation includes a set of activities to be performed during the product and process lifecycle. Broadly, we can categorize those activities into three stages:

• Process Design
• Process Qualification
• Process Verification

It is very important to understand that the success of any validation program depends upon the knowledge aggregated from the different stages including product and process validation. Such detailed information helps setting up the right approach to keep the manufacturing processes in control to ensure consistent quality of products as well as their attributes.

A comprehensive lot of information helps manufacturers to understand the loopholes in the processes and their impact to control the risks on the finished products and other relevant processes.

This induces the need for a scalable quality management system for manufacturers that can help them collect, analyze, evaluate, and utilize the quality information gathered from the different departments of the organization. Such a comprehensive system may help manufacturers to identify problems as well as opportunities for continual improvements.

In addition to pharmaceutical manufacturers, life sciences also face validation challenges. They are also progressively shifting to cloud-based environments for managing product quality while optimizing efficiency and costs. Another compelling reason to make a shift to cloud environments is the evolving tools and capabilities that enable users to control quality with utmost ease and flexibility. It further supports the culture of continuous improvement while maintaining compliance.

Why Cloud QMS for Validation? 

The cloud-based quality management solutions help to reduce the burden for the manufacturers since their quality teams often feel afraid of upgrading the traditional QMS system because of the associated extra efforts and tasks with the validation. However, there are still many companies that choose to go with traditional QMS without upgrades and making it harder for themselves to strive through competition.

Since the cloud-based quality management software is gaining traction due to sophistication, security, and cost-effectiveness, quality professionals should consider the advantages of implementing a cloud solution that complies with industry best practices, compliance standards, and security. This will help pharmaceuticals manufacturers and the life sciences companies to achieve product and process quality within the lowest cost of ownership possible that too with a simplified way of process validation.  

With a cloud-driven quality solution, the regulated organizations can leverage next-generation technological advancements without cost-extensive upgrades and maintenance required in the traditional validation, which is also referred to as “heavy lifting” QMS solutions.

The cloud QMS solutions require no additional infrastructure setting. It simply makes the process validation easy through the use of common test protocols to check and verify requirements for installation qualification (IQ) and operational qualification (OQ). The solution providers have their team of validation experts that help pharmaceutical manufacturers to experience better validation process with the reduced amount of manual efforts and daunting tasks.

The removal of the traditional validation barriers has enabled companies to maintain pace with the advanced technological solutions and features that allow them to emphasize on innovation, market response, and continual improvement for ensuring quality products delivered every time.

According to research, process validation may result in unnecessary delays in the production process. It would be even more productive to go with a powerful QMS software like Qualityze that doesn’t require you to perform validation. They have their experts to perform validation so that you can focus on business core activities and ensure safer products to the market within the specified time.

How Cloud QMS Simplifies Validation? 

The FDA requires process validation, but it doesn’t have any particular guidelines or specifications to perform it. It also requires you to document the process validation steps and technologies you are going to use. The goal is to ensure that cloud EQMS you choose simplifies validation by helping you to;

• Conduct a thorough internal audit.
• Establish a streamlined and standardized change control process
• Stay current with all the upgrades
• Perform regular risk assessments
• Improve supplier quality
• Perform process level verification and validation

Would you continue with traditional practices of validation? Or will shift to newer and improved cloud EQMS solution for simplifying validation without extensive efforts?

One of the proven solutions to which you can consider shifting to is Qualityze Enterprise Quality Management Suite. Built upon the world’s most secure and reliable platform, Salesforce.com, Qualityze strengthens your quality management strategy by standardizing the processes and workflows throughout the organization while helping you to maintain a balance between operational excellence and quality.

Qualityze is a suitable solution for every industry including the highly regulated ones like Lifesciences, Healthcare, Pharmaceuticals, Aviation, and Defense, etc. It puts you in control of managing your quality processes while enabling you to collect and evaluate the information from the different parts of the organization. It also hosts amazing features like Email Approvals, Notifications, Digital Signature, Audit Trails, Reports, and Dashboard with advanced Analytics and Reporting tools that contribute to continuous improvements by offering detailed data, trends, and insights.

So, are you ready to align your quality processes with your business quality objectives without any validation hassles?

In the fast pacing business environments, where document records have grown from hundreds to thousands and millions, the focus of document management has shifted to a large extent. It is not just about the storage and access of the content; it is about extracting valuable insights from the collected data.

Some of you might have taken the above statement in the wrong direction. However, it was not intended to say that more data means more value. If you start collecting all of it, you will probably end up cluttering the storage space. It is where; the need for Artificial Intelligence emerges.

Artificial Intelligence makes your document management systems smarter to process vast amounts of data so that you can get real value insights on trends, patterns, and behaviors of the users. It tends to improve the decision-making capability analytically.

The ability of A.I. that allows organizations to unleash the exact potential of voluminous data they collect every day reflects the more significant changes in the document management that lies ahead. It is mainly beneficial for the businesses that are trying hard to connect the dots between the paperwork and the document records in the system to track the details like patient history for healthcare establishments, a person’s account for insurance, and much more.

The only smart solution for most of the companies is to integrate the A.I. technology with its document management system to speed the processing of the controlled documents. Utilizing the ability of A.I. to make the document workflows better, faster, and smarter will help to reduce the wastage of time and resources, improving employee engagement and collaboration for executing the standard document workflows in lesser time.

Key Benefits of Using A.I. with Document Management Software

• It automates segregation and processing

A.I. has revolutionized many streams and industries by increasing their analytical ability to gain more insights from the data and make informed decisions accordingly. When it comes to document management, A.I. extends the capacity of existing systems to scan the document content, segregating it, and processing it without much human intervention.

A.I. enables organizations to read more documents than an average employee. And, it is much smarter to identify and classify the critical information from the data collected. A.I. is undoubtedly making lives and jobs simpler, in contrary to the thinking that it will take away the jobs. The interaction of human and A.I. will set a new epitome of excellence in every industry.

The employees will be able to save ample time to invest in productive chores for business growth rather than just reading the documents, classifying them, and collecting them in a specific order.

• It simplified data extraction

With the use of A.I. integrated document management solution, organizations can have a faster information extraction process even if it requires to scan through multiple documents at a time.

Many organizations are already using the A.I., including Google, to provide users with the most relevant information they are searching for. A.I. algorithms can be defined with specific criteria to sort and extract the exact information any user is looking for. The technology has enormous potential for organizations than ever.

Whether it’s about extracting information piece from an old SOP or fetching details from the previous invoices, the integration of A.I. with the existing document management system can help you work more efficiently and productively.

• It eases document collection and grouping

The concept of using A.I. algorithms to perform the data collection and grouping from a bunch of documents is not relatively new. It is similar to what we witness on the web for quite a long now. With A.I., the level of accuracy is way better.

The A.I. integrated document management system is considerably better to find the relevant document by identifying their similarities. As a result, you can have better groups of data collected, and you will be able to search for documents with more ease and precision.

The searchability and collection of data are primarily required for the healthcare forms wherein the staff needs to manage multiple device history records, patient records, and many other critical documents. On top of all, searching for records related to a particular patient or device can take up a lot of time. Hence, A.I. with DMS can make an efficient deal for people who deal with hundreds of documents a day.

Qualityze cloud-based Document Management software is the one that can be easily integrated with A.I. to perform search and classification based on the user defined criteria. Are you ready to experience the difference in extracting meaningful data from your critical documents, including contracts, SLAs, and other paper records?

• It streamlines the unstructured data

Organizations need to pay attention to the amounts of unstructured data they are collecting. It can cost them efficiency, resources, and money. Such data makes it increasingly challenging for organizations to perform deep-dive analysis and get some really insightful information.

The rush of unstructured data is expected to grow exponentially in the next five years. If organizations do not adopt smarter technological solutions now, they are likely to experience more significant troubles in the next few years. A.I., along with a smart document management system, can play a significant role in managing the unstructured data by streamlining the data based on defined criteria.

Don’t let the unstructured data block all the success for your organization and streamline document management with A.I.

• It supports document creation and security

A.I. integrated document management systems not only help in document creation, but also help managing security for all your controlled and confidential documents. Artificial Intelligence makes the document system smarter to identify sensitive and confidential information from the documents and flag them to manage individually.

Coming back to document creation, A.I. has already marked its excellence through apps like Grammarly that help edit documents without human intervention. Whether you want to draft compliance records or create some internal process documents, everything will be simple, efficient, and faster with the integration of A.I. and next-generation document management solutions.

With such intelligence-based technologies, we will soon be in a better position to manage our data and its key insights for business improvements and growth.

Transforming Document Management with A.I.

There is an inestimable potential in A.I. driven electronic document management solution for now. Even the document management solution providers are ready to take maximum advantage of this new trend by making their solutions integration-enabled. The industries that produce voluminous documents on an everyday basis may identify many new possibilities to utilize data and insights and make significant improvements. A healthcare firm could use A.I. to keep control of patient records while pharmaceuticals and medical devices companies could keep the processes aligned with specification documents by integrating A.I. to streamline the workflows at every level.

Whatever the document management solution you choose, you can leverage the prominent A.I. benefits, including improved efficiency, agile processes, data-driven decision-making processes, and reduced operational costs. And, these benefits are not limited to the regulated industries only- anyone who creates and manages documents on an everyday basis can leverage the mentioned benefits for accelerated document management.

While many of the software companies are figuring a way out, there is a document solution already available to you i.e., Qualityze Document Management Solution with seamless integration functionality. It has multiple in-built capabilities like eSignature, Watermark, Centralized Database, Configurable Workflows, and more. The cloud-driven solution makes it easy for you to manage document quality and compliance consistently, minimizing the chances of errors and duplicity.

Would you like to know more about the Qualityze Document Management Solution and its integration capability to unleash the potential of A.I. for your business? Get in touch with our customer success team at 1-877-207-8616 or write to us at info@qualityze.com, and we will be right there for you!

An audit is an inevitable part of quality assurance since it helps the organization to verify the best practices at every level. With the regulatory bodies getting more stringent, the audits are now more accountable. The audit findings provide quality teams more insights on the process performance so they can make appropriate changes and align processes with their quality objectives.

However, going through an audit can be a different experience for every organization based on their regular business practices. For example – the companies that are following best practices and can demonstrate them through in well-documented and recorded form may find it easy to pass an audit. On the other hand, the companies having no proper documentation can find audits tedious and time-consuming process.

Audits matter for accountability, traceability, and visibility of the data every organization produces regularly. A company needs to take audit recommendations seriously if it wants to improve its process and product quality. Audits also drive continuous improvements, which is an essential regulatory requirement for organizations striving for consistent excellence and compliance.

Having an Audits Management System, helps organization to drive multiple benefits, regardless of its industry focus. Five key benefits of conducting regular internal and external reviews are:

Eliminating Inefficiencies

Regular audits help quality teams to identify the process and product inefficiencies by verifying the best practices followed in the organization.

The most common habit that often leads to inefficiencies is creating a process and then continuing with it without any review. However, the current cutting-edge business environment demands more tweaks in every process to achieve goals within the specified time.

There is a need for change in our perception of inefficiencies. For example – if our goals evolve by the time, we must ensure that our processes and system also evolve. It is rightly quoted that

“You can’t get different results by doing things the same way.”

Also, you should measure every component of your business operations through detailed audits to keep a check on inefficiencies, including documentation and communication, to ensure everyone is on the same page.

Improve Credibility

Audits confirm the worthiness of the processes that drive continuous improvements. They are an integral part of workflows and reassure that all the processes are aligned well with the quality objectives.

The regulatory audits are thorough than internal audits. They provide reassurance about the organization’s commitment to the best practices to achieve customer and compliance requirements. The verified companies tend to gain more credibility in the marketplace, gaining more customer confidence.

Keeping your processes regularly audited ensures that your organization follows best practices to produce and deliver the best quality products consistently.

The credibility could mean more business for you since it reflects the perfection in the way you manage the business process even if it is handling customer complaints. Credibility is the confidence that backs you firmly in the competitive marketplace.

Better Planning and Quality Improvements

Audits enable timely planning of the quality processes in the organization so to ensure efficient utilization of the resources. It also includes identification of risks, the scope of improvements, value-adding steps, and the gaps that should be effectively managed to achieve desired results.

Audits help evaluate every aspect of process performance based on the indicators and metrics defined so that you can plan the new activities and audits accordingly. And if you will be able to plan the audit frequency for different types of audits such as IT audit, Process audit, System audit, and more, you will be managing the inefficiencies more effectively.

Audits also help drive quality improvements in the organization by efficiently tracking the ongoing process and activities.

Maintaining compliance

The main objective of performing audits is to check whether the processes designed in the organization are aligned with the compliance requirements defined by the regulatory bodies.

Audits determine if the documentation is up-to-date, tools are upgraded, the work instructions are communicated well, the working environment is safe and suitable, and maintenance of records to reassure preliminary compliance guidelines. However, third-party audits can be more comprehensive based on the specific requirements.

Increased Traceability

Audits and traceability are closely connected, especially when it comes to business success.

Audits helps to trace product and process performance right from the beginning – be it supply chain process, an inspection of raw materials, production, or quality checks. It maintains a trail of what, when, and who for quick assessment of processes.

The increased traceability further works as a risk-management tool for the organizations that helps to prevent the delivery of faulty or unsafe products to the market. To put simple, a streamlined audit process helps managing product recalls much more effectively.

Opting the Software as Solution for Regular Audits

The traditional audit management systems are no longer efficient in tracking the issues and driving process-level improvements. Instead, you miss a lot of growth opportunities. Your audit team will spend most of its productive time in manual data entry, which is hard to track, manage, and evaluate.

In addition to the collection of data, many other audit processes require an ample amount of time from the planning till execution, like creating checklists, managing audit findings, reducing audit cycle time and costs, etc. while fostering continuous improvement.

The data records being generated every hour adds to the complexity of conducting manual internal audits. The best solution to escape all the complexities involved in the manual audits is implementing a cloud-driven audit management system that can manage operational and compliance risks with end-to-end process management of internal and external audits.

The Audit Management Software system, like Qualityze, is the next-generation solution to identify and eliminate inefficiencies from the system. It is a cloud-driven solution that features an intuitive user interface. It comprises capabilities like digital signature, audit trail, email approval, audit calendar, scheduler, and much more to achieve audit excellence while meeting compliance.

You can create a checklist library with customized audit checklist templates, do audit planning effectively, improve overall audit program efficiency while reducing cost, manage audit findings, drive continuous improvement, offer greater visibility of audit results. You can conduct offline audits too.

From creating an audit plan till closure, Qualityze helps you standardize all the processes to ensure consistency. You can also leverage automatic tracking of audit activities, set the evaluation criteria, uniform tracking methodology, and corrective action tracking tools through this powerful audit solution.

Would you like to streamline and standardize the audit management processes in your organization to drive significant improvements?

Get in touch with our customer success team on 1-877-207-8616 or email at info@qualityze.com, and we will help you in making audits workflows streamlined.

Artificial intelligence is changing the way of doing business for every industry, from general manufacturing to the medical cannabis industry. The next generation of technology is all about using data for the effective utilization of the resources while keeping the operational costs to the minimum. Today, we will talk about the role of artificial intelligence in improving the quality and supply chains for the cannabis industry.

Like every other industry, Cannabis is also leveraging many exciting benefits with the use of artificial intelligence, especially as a resolution to the supply chain challenges. These challenges are holding the cannabis industry back to pace up with the increasing demand in the marketplace. Many other problems could arise out of poor supply chain conditions such as:

• Lack of retail locations
• Poor quality product
• Unnecessary delays
• Unauthorized selling

Artificial intelligence is preferred for streamlining the business process for improved efficiency. The A.I. based solutions are deployed for every level of the business from production to supply chain and customer satisfaction.

3 Ways Artificial intelligence can help the Cannabis Industry to Revolutionize

Artificial intelligence is considered a significant revolution in the world of technology. It will help businesses to drive better customer experiences by keeping track of their data, preferences, behaviors, and other patterns. Three exciting ways that A.I. will genuinely revolutionize the quality and supply chain management for the cannabis industry are:

Streamlining Cannabis Compliance with Automation

Automation is the buzz term associated with artificial intelligence. It has significant implications for the cannabis industry too. Relying on the manual models to ensure product conformity can turn out to be inefficient and dangerous, mainly when the rules differ from region to region.

The best advice for maximum compliance is – Don’t take unnecessary risks. Make use of the A.I. algorithm and automate the processes to stay away from the issues. The next-generation technology is capable of resolving the problems quite efficiently. Many digital mature companies prefer to have a well-defined A.I. strategy for improved productivity and profitability.

The automation of compliance could save cannabis companies from severe repercussions, not limited to financial. It could protect from penalties too. Using the right quality management software and artificial intelligence could bring peace of mind for cannabis manufacturers since they would have a better hold of activities like license management, inventory traceability, nonconformances tracking, and much more.

However, it’s entirely a business’s choice to utilize any software to automate compliance-related activities. The most important thing is to integrate the elected software with the existing systems and processes to ensure maximum quality and compliance since it sets the stage for better returns on the investments.

Providing the Consolidated Data Infrastructure for Improved Decision Making

For the industry like Cannabis, it tends to become hard to lend money from traditional banks due to the federal restrictions. A.I. plays a significant role here. It helps cannabis companies to keep track of their investments, and they can use this data to create their future roadmap.

With the use of artificial intelligence to collect data for years, cannabis companies could have a mature data inventory. It will not help them to drive better customer service but also to streamline their supply chain activities. Data is the most powerful asset that cannabis industries can put to work. The critical insights will help them make better business decisions, outlining the new growth opportunities in the pipeline.

We can say that data is money. Such insightful technology can help businesses to track their operations, including the sales. The companies could end up mitigating many roadblocks with the use of analytics data, which will eventually help them generate more revenue in lowered operational costs.

Would you still let the power of data be subsumed? Or will create a data infrastructure to strengthen your operations and decisions with mature insights. The choice is yours!

Drive Value through Supply Chains

Analyzing data is something in practice for a long time – earlier by humans and now using artificial intelligence – to make better decisions. But, implementing those decisions is something that still human does the best by integrating available systems and diversified information resources. The most important thing that companies need today is understanding the data and insights to map the potential growth and improvement opportunities, especially for the supply chain activities that are highly vulnerable to the errors.

It requires senior management in action. They should review and evaluate the analytics tools they are currently using. Is the tool efficient enough to fetch more significant insights into the supply chain? The more information they will be able to bring, the better actions they will be able to take. And, A.I. is the data tool to help future centric companies the most to mitigate inefficiencies and increase revenue

The analytics can help cannabis companies to go a long way, in terms of growth, since they need to maintain the supplier quality at different levels. The more value they will bring to business with A.I. intervention, the higher will be chances of success for them since the data will help them to take the right steps for the customer as well as employee satisfaction.

The most important thing that everyone should understand and make a note of is that A.I. could lead to dismissal of human interaction. It is not valid. The most critical thinking required to use the data comes from humans only. Hence, the A.I. and human can be integrated to make the savviest combination to make significant improvements, especially for cannabis supply chains.

Hence, cannabis industries should not delay integrating A.I. in their business processes – whether it’s about making better decisions or fostering a culture of quality and continuous improvements.

To unleash the maximum potential of A.I., you need to have robust quality management systems in place that can be easily integrated with third-party applications seamlessly. One such solution is Qualityze EQMS Suite. It is robust and secure quality solution, built on the Salesforce platform, that helps achieving quality and compliance standards by streamlining the quality processes. You can integrate it with A.I. to get more detailed insights and transform your QMS into a quality decision-making engine.

Qualityze EQMS leverages flexibility, reliability, scalability, and compliance with its advanced features and next-generation functionalities like eSignature, Audit Trail, Alerts, Notifications, Dashboards, Reports, and much more. The configurable workflows and user-friendly interface completely redefine the experience in quality management for your business.

It requires no infrastructure or maintenance costs. You can have more insights by requesting a free demo today.

Have more queries regarding quality management and supplier quality management with A.I. in Cannabis? Get in touch with our customer success team on 1-877-207-8616 or write to us at info@qualityze.com, and we will be right there for you!