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Essential Elements of Quality Management in Food Industry

Chirag Panjwani on January 30, 2023

The globalisation has made the manufacturing market more competitive, by offering new opportunities to businesses old and new. This should not be considered as a threat to the survival of existing manufacturers; in fact, it is a challenge that they should take up. Because this challenge, actually poses an opportunity to gain customer loyalty through the enhanced products and improved services offered in the quest to stand up to the challenge.

By enhanced products we mean ones—that suitably cater to the specific needs and concerns of the customers. Also, when it comes to competitiveness, one obvious question that arises is- “With the rising competition bar, what makes the top manufacturers stand out from the league?”

The answer to this question is “quality of their own products & services”. By maximising suitability and quality of their products for the consumer usage, manufacturers succeed in excelling in their field— and thus in building a sustainable brand image.

Looking for a digital solution? Explore our “QMS software for food industries“

Therefore, to become a successful manufacturer, robust quality control, is of utmost importance. For which, manufacturers need to opt a feature-rich quality management system. But if you are a tenderfoot, then before implementing a quality software, knowing the concept of quality and food quality management is essential.

This blog takes you to a knowledge-intended journey of exploring the term “quality” and the essential elements of a QMS.

The Quality Concept-

“Quality is a comprehensive term that includes two meanings: product characteristics that lead to customer satisfaction and the absence of failures. Still, this does not defines “Quality” as a whole.

The customer needs are not only related to these two intrinsic characteristics of the product, but also to its availability in the market, it’s appropriate pricing and suitable packaging.

These specifications altogether ensure that the customer will buy a safe product standing at par with what is mentioned on the label, without having any health threats.

For these objectives to be achieved, it is necessary to have an efficient food quality management system in place that ensures operational excellence at each level of the organisation. Talking of an ideal QMS, it must have the following capabilities.

Essential elements of QMS in Food Industry

Quality Control- To ensure safety and quality of the food for consumers, adhering to quality requirements becomes a mandate for the food manufacturers. With the absence of quality control procedures, the contaminated foods can easily make way to the markets.

In avoiding such situations, the Quality Control module of a Quality Software plays a key role. Because it allows manufacturers to create and apply quality tests on the products, at all important junctures of the food supply chain-, that too with set target values.

This ensures quality throughout the product lifecycle: i.e., when materials enter the facility, when they are put ahead for production, and when they are being shipped to the customers. Also, based on the test results of pass/fail, manufacturers get the convenience of accepting and rejecting products accordingly.

Standard Operating Procedures (SOPs) – Food manufacturing refers to the process of turning fresh ingredients into consumable food products. This includes the process of high-volume mixing of multiple ingredients that too in a set order, to manufacture finished goods. These finished goods must have uniform consistency. Even a small deviation in the procedure, could lead to fluctuations in the product quality of the finished goods.

Therefore, documenting processes in the form of Standard Operating Procedures (SOPs) helps organisations ensure error-free and consistent processes throughout the supply chain. This is the reason why the Advanced SOP Module turns out to be one of the prominent features that should not be given away with.

Compliance Management- Throughout the supply chain, adherence to set safety laws imposed by the regulatory bodies ensures that the food item is not unsafe, misbranded, or low-graded for the human consumption.

This feature helps manufacturers comply with major regulatory standards, including GFSI, ISO, HACCP, GMP, and FDA requirements.

See how QMS simplifies food compliance— “Request a Demo“

Non-Conformance (NC) & Corrective Action Preventive Action (CAPA)- Non-conformance reports that there is something wrong with the process or product due to which the outcome fails to match the required product specifications. In situations like this, the NC/CAPA functionality of an efficient QMS comes to the rescue. It helps in successfully dealing with every type of non-conformity that could occur such as:

Product non-conformity– Which relates to product issues identified during quality management or by customer complaints.
Process non-conformity– Which relates to downtime, machine problems, operational inconsistency, etc.
System non-conformity– Which is identified by internal audit system
Material non-conformity– Which occurs due to expired materials, ingredients

The NC functionality finds the root cause of the occurred non-conformity, wile the CAPA suggests the required corrective needed to be applied, and prevents its recurrence, comes out as an un-negotiable part of the QMS system.

Document Management- This capability is essential to control the pile of documents a food business needs to manage for several reasons. This includes formula/recipe details, SOPs, compliance policies, training manuals, recall procedures, labels, etc. These crucial records must be accessible when required, and hence needs to be systematically managed.

But manual management of these documents could lead to maximised manpower requirement & minimised productivity. That’s the reason the document management feature can’t be ignored in the list of essential elements of a Quality Management system. It automates the task of creating, storing, managing, and retrieving the documents when required— and becomes a significant contributor in enhancing the organisational productivity.

Risk Management- It is the act of setting up prevention strategies to avert potential issues from occurring. Actually, the risk management feature efficiently identifies the potential areas that are vulnerable to business helping organisations carry out necessary actions in response. Though there could be numerous areas of risks in a food manufacturing business, but, the prominent ones out of all are:

Supply chain risks– Threats from the quality of materials arriving at the facility
Cyber risks– Data corruption, data loss, data manipulation
Natural Hazards– Equipment failure, earthquake, Fire outbreak, etc.

A risk management system can help you manage, track and mitigate these risks and that’s the reason why a proper risk management approach is a must-have feature for a robust food quality management system and should not be overlooked by the manufacturers.

Final Thoughts-

Food manufacturing involves processing of highly sensitive and perishable items, which makes it more challenging for the manufacturers of that industry to sustain. Hence, right from the purchasing of raw materials to delivery of finished goods, everything needs to be not just streamlined and organised, but inspected too.

For this, other than a good QMS software like QualityPro, no other strategy would deliver better results. If you are also looking to inject a culture of quality into your business, then get in touch with our team of experts today.

Looking to improve quality practices in food and beverages? “Contact Us“

What is the Difference between a QMS, EQMS, and an EDMS?

Chirag Panjwani on January 18, 2023

With Quality getting paramount importance everywhere, process manufacturing is no different. Terms like Quality Management System (QMS), Electronic Quality Management System (EQMS), and electronic Document Management System (EDMS) are gaining traction in board rooms, business meetings and on Google Search too.

If you have been a part of such discussions, or have overheard or are wishing to know what these terms actually mean and function, then you are at the right place This blog elaborates their meanings, purpose and the distinguishing characteristics of them all for a better understanding. Continue reading-

What is a QMS?

A quality management software (QMS) is a formalized system that documents/describes the workflows, procedures, and responsibilities for achieving a company’s quality policies and objectives, the international standard specifying requirements for quality management systems is ISO 9001:2015 and it is one of the most widely used and prominent approach to quality management systems.

A QMS manages and coordinates an organization’s actions in order to conform to consumer and regulatory standards.

Who needs QMS Software?

In industries such as electronics, automotive, manufacturing, food, fmcg and many more, where ensuring quality and safety is critical, the implementation of robust quality management systems (QMS) holds paramount importance.

For companies operating in these sectors, compliance with specific standards and regulations governing quality management is mandatory to legally sell their products.

Government agencies require these industries to adhere to stringent quality management system standards to ensure adherence to safety protocols and regulatory requirements.

Traditional Paper-based QMS Software –

Managing documents through traditional paper-based methods has become outdated. The process demands considerable effort, time, and resources to keep data updated, often requiring workers to meticulously handle data entry tasks. Yet, despite their best efforts, there’s always a chance of missing something or making errors.

Manual file management is integral to various operations such as onboarding, record-keeping, investigations, and both internal and external audits. Even minor errors in the data can lead to significant miscalculations. Hence, there’s an urgent need to transition to an electronic data storage system.

This transition aims to minimize errors, boost productivity, and allocate resources towards tasks that significantly contribute to the overall efficiency.

What is eQMS Software?

A modernized approach to quality management systems is the electronic quality management system (eQMS). It revolutionizes the management and documentation of organizational-wide business processes like product development, quality assurance, and compliance, eliminating the need for manual paperwork.

The cloud-based version of eQMS operates on cloud servers and is accessible only by authorized users from any location and at any time. Essentially, eQMS encompasses all the components present in QMS solutions but with the added advantage of centralized accessibility and enhanced security.

eQMS has demonstrated superior performance over traditional QMS software due to the ease, efficiency, and flexibility it provides compared to conventional quality management systems.

Difference between QMS system and eQMS system

What is EDMS Software?

An electronic document management system, or EDMS system, is a digital platform designed to manage various types of documents, whether they’re related to the Quality Management System, product development, HR, legal, or other categories. This system is versatile and can store different file formats like Microsoft Word, PDFs, 3D drawings, and more.

Traditionally, employees spent a considerable amount of time searching for and organizing documents manually, impacting their productivity in core tasks.

The transition from paper-based documentation to Electronic Document Management Systems has revolutionized accessibility, making documents available on smartphones or tablets.

EDMS solution isn’t limited to text documents; it accommodates various file types like images, videos, and audio files. It offers a unified view of all documents and incorporates features for printing, scanning, and storage.

A key advantage of an efficient EDMS software is its ability to automate document-related workflows, integrating seamlessly with other software such as ERP, QMS, or CRM systems. This connectivity streamlines processes and enhances overall operational efficiency.

This is how EDMS helps in building Quality Management –

To create a digital Quality management system, you can migrate all of your current quality documentation onto an EDMS, which is a cloud-based platform. It can benefit you with –

Controlled document lifecycle: An EDMS streamlines document classification, organization, and archiving from creation to archival, enhancing searchability and indexing accuracy.
Tailored workflows: Tailored for quality specialists, an EDMS offers pre-defined processes while allowing customization to suit unique operations, unlike an eQMS.
Change and design control: Flexible adjustments to quality processes with comprehensive record-keeping for all modifications.
Document review alerts: Ensures timely completion of review and approval cycles, maintaining the flow of documents within the system.
Version control and audit trails: Automatically generates audit trails, displaying version histories, changes, and approvals for document transparency.
Integration with e-signatures: Compliance-driven e-signature functionality (e.g., FDA 21 CFR part 11) to authorize documentations as per regulations.
Enhanced SOPs and compliance records: Robust search and navigation features in an EDMS facilitate compliance inquiries, offering flexibility in SOP management while serving as a unified data source.

Difference between QMS, EQMS, and EDMS

While QMS solutions aim to meet quality procedures, they have grown obsolete and traditional; in contrast, eQMS has all the features built in accordance with technological advancements and rapidly shifting compliance standards. The line of distinction between these two names is extremely thin.

However, we may conclude that eQMS is a more contemporary and effective version of QMS solutions. The eQMS seeks to automate quality management operations, maintain compliance, monitor product quality, identify non-conformance, and conduct audit activities while reducing costs & time to market by keeping all of the important company information in a centralized repository.

When it comes to EDMS, it differs slightly from eQMS and QMS. The area that this solution covers completely is the documentation and its lifecycle from creation to storage, however, EDMS is also a part of handling quality and eQMS.

QMS, EQMS, or EDMS, which one do you need?

Choosing the right solutions out of these three depends on the type of need your business operations have. The choice becomes clear only when you know what your business requirements are, what your strategy is, and which solution fits the best within your business ecosystem.

Venn diagram of QMS, EQMS and EDMS Systems

You can prefer an eQMS system as it is a complete solution serving the needs of a QMS and an EDMS. It outdoes the traditional paper-based quality management systems in ways uncountable and is quickly becoming the new standard for quality management across businesses operating in various industries and of different sizes.

If you’re also looking for an eQMS that can take your quality management process to the next level and instills a culture of Quality, QualityPro is the right solution for you. Contact our experts for details.

Four Key Ways QMS Software Supports Change Management

Chirag Panjwani on September 27, 2022

Overview

Heightened global competition has motivated manufacturing companies to constantly innovate their product offerings. To keep pace with this accelerated pace of change, companies need to develop a dynamic work culture and environment.

Change does not come naturally to people or organizations and without proper management, a change can cost precious time and money. It is also vital to measure the scale, magnitude, duration and strategic importance of the change.

Organizations would do well to address and balance the multiple aspects of change like people, process, technology etc. Creating a change management plan can help with a smoother transition from the old to the new.

While proactively combating resistance to change, companies need to set clear goals for the changes and monitor the results vigorously. By creating effective strategies to implement change, manufacturing organizations can ease out the process for their people.

Simplify change management with our QMS “Request a demo” now.

What is Change Management?

Change management is the process of planning, implementing and validating changes in the organization. It refers to the organization’s ability to handle modifications like implementing new technology, adjusting existing processes and shifting organizational hierarchy.

Change managers need to set key performance indicators (KPIs) and relevant metrics to measure the effects of the change. In the present scenario of rapid product changes, the co-ordination of design centers, suppliers, testing labs, manufacturing facilities, offshore plants and the marketing department becomes very critical in change management.

Change can be a consequence of innovation, customer complaints, material returns, non-conformances and similar occurrences. Upon implementing a QMS (Quality Management System) in the organization, managers can standardize their response to every new development with automation.

It can even shorten the change process cycle time and reduce the impact of change on everyday operations. We will elaborate about the benefits of QMS for change management further in the blog, but let us first discuss the process of change management.

Process of Change Management

Businesses must constantly evolve and adapt to meet a variety of challenges like changes in technology, rise of new competitors, a shift in laws/regulations or any underlying economic trends. Change processes have a set of starting conditions and a functional endpoint.

Change initiatives may be different from each other, but they typically follow a similar process. To effectively manage change, managers must thoroughly understand the steps involved. The key steps in the change management process are listed below:

Prepare – The organization needs to be prepared for change, both logistically and culturally. All employees should recognize and understand the purpose of change.
Plan – The definitions of KPIs and strategic goals should be pre-defined. The scope of the project and the hierarchy of reporting must be laid out beforehand.

Implement – The steps laid out by the management must be diligently followed. Employees need to anticipate roadblocks and prevent, remove, or mitigate them once identified.

Embed – The changes inculcated by the process should become part of the company culture. Change managers need to ensure that the process doesn’t revert back to the old ways.

Review – conducting analysis and review to make sure that the change was successfully implemented. It can offer valuable insights that can be leveraged in future change efforts.

How QMS Supports Change Management

How QMS system supports change management

Paper-based quality processes can hinder innovation-centric changes and even cause non-compliance in a regulated industry. By implementing a QMS, the change is managed in a workflow-based system and quality is benchmarked at every step.

Discover how QMS supports change management— “Contact us” today.

The “Make it once, change if often” philosophy of the present product developers can benefit from the dynamic work environment created with the help of a QMS. Let’s discuss the four key ways QMS software supports change management:

Change Process Automation – Automation of the change management process results in increased control over the variables. A QMS provides the right tools for the organization to exercise control over the tasks, processes and documents of change.

Everything including routing, follow-up and approval can automated through a QMS. Managers can effectively define process ownership and user control for increased accountability. Automatic escalation can speed up departmental collaboration and new approvals can automatically supersede any old versions.

Transparent Change History – A time-stamped and secure audit trail enables the stakeholders/auditors/regulators to view the entire edit history of documents in a chronological order. Complete record of people who request, approve and validate the changes is also saved in the system to allow for complete transparency.

QMS can also present key metrics relating to open change tasks on a unified dashboard and generate reports in an efficient manner to identify bottlenecks and other issues.

Closed-loop Change Management – Vigilance is not enough for compliance. Organizations need a QMS to follow a proactive approach by connecting all quality processes. CAPA issues and deviations will seamlessly trigger change management and training through the QMS system.

If a CAPA issue requires new training, the QMS will facilitate task completion with automatic notification and follow up. The system unites different processes and individual users into a holistic compliance effort so that every issue is identified and resolved.

Shorter Change Cycle Time – Efficient change management and change control leads to timely regulatory submissions and faster time to market. Once a change control request gets approved, a QMS automatically generates and routes all the related documents (Ex. SOP, change order) to the concerned departments.

Gone are the days, when this process was done via long trails of e-mail or through in-person meetings. Every step of implementation and post-implementation assessment are automated with QMS to close the loop quickly and effectively.

QMS can help companies achieve change management and change control according to cGMP regulations and ensure product safety and quality. While every regulated company wants to comply with requirements, they need to leverage the right QMS software to attain and maintain compliance despite the constant change in their operations.

QualityPro is a next-gen manufacturing QMS software that supports change management along with all the other quality management requirements of a manufacturing company.

Quality Risk Management Software: Definition and Benefits

Chirag Panjwani on September 27, 2022

Managing a business involves a variety of risks, including natural calamities- something that’s completely out of your control. These risks have an enormous potential to make your business face downfall or distress. Even the tiniest risk has the capability to put your entire business process at stake.

And, what’s more? They can be expensive and time-consuming to fix. Regardless of company size, CEOs, VPs, or risk management officers should foresee the risks and have a plan to curtail these risks and address them before they hamper their business.

In this blog, we’ll define risk management, go through all the key points, and explain how our quality risk management software can help you manage risks. With all this info, you’ll be able to plan your risk management strategy and needs better.

Table of Content:

Overview
What is Quality Risk Management?
Quality Risk Management Principles
Quality Risk Management Process
Why Is Quality Risk Management Software Crucial for Your Company?
QualityPro QMS: Simplifying Risk Management for Your Business
Summing Up

Overview

Ideally, I would say it is impossible to eliminate all the risks but, it is possible to think about all the potential risk factors that your business could experience and stay prepared to handle them. And this is doable with automated risk management software.

An effective risk management software focuses on the connection between risks and their significant harmful impacts that can stop organizations from fulfilling their strategic goals.

Let us first know what risk management is and what its causes are –

What is Quality Risk Management?

The process of identifying, assessing, and controlling threats to an organization’s assets and earnings is known as risk management.

Risks originate from a range of sources and can be both internal and external. Internal risks can be caused due to your employees, vendors, leadership decisions, etc. whereas external risks can be caused by a number of things such as financial uncertainty, legal responsibilities, technological problems, strategic management blunders, accidents, and natural calamities.

Talking about the situation that occurred say two years before,

When COVID-19 entered the market, businesses faced a significant threat to their operations. Prior to the pandemic, nobody ever imagined or was prepared to deal with the level of impact it had on practically everything, including businesses.

Numerous businesses collapsed, many people lost their jobs, and factories were shut down, all of which resulted in huge losses. Now that the COVID-19 effects are stabilized, CEOs and Directors of various companies are taking a fresh start to look at their risk management programs. They are reconsidering their risk exposure and examining risk-mechanism processes.

Companies are considering the competitive advantages of a proactive strategy and substituting it for their existing strategies, reducing the use of traditional techniques like guarding against past risks, changing risk management only after a risk has caused harm, etc. Business interest in achieving sustainability, resilience, and corporate agility has increased because of this.

Before moving further, it is now important to look at the principle of risk management.

Quality Risk Management Principles

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) states that there are two main principles of quality risk management:

A better risk evaluation should be based on facts and research from scientific knowledge and should ultimately aim to protect customers.

A quality management procedure should be proportional to risk level- higher the level of risk, stronger the plan. The time required, and formal documentation requirements should all be in line with the degree of risk.

Quality Risk Management Process

The five steps of ISO’s risk management approach are as follows:

Step 1: Identify the risks:

List out all the risks that your company might experience while operating. Generally, this process is performed routinely. Start a risk assessment by looking at the elements in your business and surroundings that could be risky, such as regulatory, legal, environmental, market, and other hazards.

You should be aware of potential threats to your company, such as technical hazards, single point of failure (SPOF) dangers, and natural calamities.

Step 2: Analyze the risks

After identifying the risks, conduct a risk analysis. Some risks can bring your business to a standstill, while some will only be minor inconveniences. To analyze each threat and determine its potential disruption, ask: “How probable are these risks to occur?” And, if it occurs, then what are the consequences?

You can then establish a link between the risks and varied factors within your organization. This will help you comprehend how many business operations the risk influences. The risk increases as the number of functions increases.

Step 3: Evaluate and prioritize every risk

Rank and order each risk according to its intensity. This helps the risk management team to view and understand the complete risk exposure of your firm. For instance, threats that might only cause little inconvenience should be given less importance than those that could result in catastrophic losses.

Determine your risk appetite and tolerance by creating a risk profile. Some businesses feel confident taking a lot of chances, while others desire to take no risks at all.

Step 4: Treat your risks

Create a risk management system to mitigate each risk. You and your team should start by addressing the risk with the highest priority in order to prevent it from jeopardizing your organization. Contacting the appropriate experts in each field where the risk exists is a clever way to begin.

Step 5: Monitor your risks

Determine whether your risk mitigation activities are sufficient or whether you need to make any changes by routinely monitoring, tracking, and reviewing your performance. If the risk management approach put in place is not workable, your team will have to start again with a fresh procedure.

To solve issues, avoid acting on impulse and getting into “firefighting mode”. Instead, a cool, clear perspective will help you limit the damage caused by project hazards and seize opportunities.

Why Is Quality Risk Management Software Crucial for Your Company?

If you are still not convinced, consider the repercussions of delaying the implementation of a competent risk control strategy until you know how things play out for your company’s bottom line. The picture below mentioned in your business that might make you think again about establishing a risk management system, if still not convinced-

Deficiency or Limited Growth

A risk management system can help and facilitate the expansion of your business. There is still a probability that some threats may develop despite your best efforts, no doubt. However, after identifying, evaluating, and controlling risk, your odds of success will increase, enabling more confident decision-making.

Lawsuits

Companies that break laws and regulations have the risk of being sued by the government, employees, customers, rival companies, or other parties. If you find yourself in one of these circumstances, your company may have to spend a lot of money on legal bills, settlement costs, or even both. However, adopting a risk management system can limit or even dilute chances of such situations.

Large Losses

Additionally, inefficient risk management has a big monetary impact. You stand to lose a lot if you do not have one. This could even include lower market share just because you weren’t able to anticipate changes in the market environment. You risk pecuniary loss if you don’t plan for the risks of growing your company. If you’re not prepared to manage issues, your company’s reputation could also be permanently harmed.

Key Benefits of Using Quality Risk Management Software

Speaking directly, if not adopting a quality risk management system brings about above-mentioned challenges, implementing one-

Quality Management Software With Risk Management

QualityPro: Simplifying Risk Management for Your Business

QualityPro gives you a thorough understanding of your business’s risk landscape. This covers all product lines, company divisions, processes, quality control, document management, and much more.

You can easily identify and mitigate long-term system, process, and product risks with the help of this risk management software’s tracking and proactive management.

It is an innovative tool that helps in mitigating and avoiding risks as well as stealth process flaws that are in line with their impact and likelihood of occurring.

This Risk Management System creates a secure and simple-to-understand platform with modern capabilities, allowing you to keep a rigorous eye on risk updates.

The list of features that follows clearly illustrates why QualityPro Risk Management System is the top choice in the industry:

Summing Up:

The pandemic is a great example of a risk issue that emphasizes on taking a holistic, long-term strategic view and action on the various kinds of risks that could hurt you as a company. It’s time for businesses to think about controlling threats and utilizing them to their advantage in order to minimize any bad effects on the company.

QualityPro QMS Software for manufacturing industry enables you to evaluate risks and identify the broad effects of each risk more quickly by providing risk heat maps, dashboards, and reports.

Schedule a demo to see how easy it is to know what risks to mitigate, how to mitigate them, track workflows, collect and store documents, and much more!

What is Electronic Quality Management System (eQMS Software)?

Chirag Panjwani on July 27, 2022

Overview
What is Electronic Quality Management System?
Difference between QMS and eQMS
Develop a Culture of Quality
What are the Features of an Electronic Quality Management System?
What are the Benefits of Electronic Quality Management Software?
Final Thoughts

Overview

Historically, paper-based and spreadsheet-centric quality systems were used to monitor and analyze quality-related data. Manual data entries and disconnected files made it difficult to track and manage quality-related information. Regarding challenges, while addressing top-quality management objectives for life sciences industry, respondent results were:

Quality management software (eQMS Software)

All thanks to the evolution of integrated IT-based systems like eQMS that made it easier to record and report quality variables across various access points. This blog discusses the definition, functions, benefits, and future of eQMS software with respect to total quality management.

Seeking smarter quality management? Explore our “eQMS Solutions“ today.

What is Electronic Quality Management System?

An Electronic Quality Management System (eQMS) is a software solution designed to electronically handle, document, and manage quality-related processes within an organization. Its primary objective is to ensure that products meet required standards, are free from defects, and operate within defined tolerances.

This software encompasses a range of techniques, structures, processes, and resources necessary for efficient Total Quality Management (TQM) practices. By leveraging an eQMS, organizations aim to enhance process efficiency and minimize human error.

One of its key advantages lies in its ability to proactively identify potential quality issues before they manifest. It grants enhanced visibility into Quality Assurance (QA) and Quality Control (QC) processes within a manufacturing organization.

Core functionalities of an eQMS include compliance management, change management, investigation of adverse events, initiating corrective and preventive actions, managing risks, and integrating complaint management into the quality process.

The system operates as a closed-loop, ensuring accountability at every level of the quality management process.

eQMS software can be implemented through various deployment models such as on-premise, cloud-based, or hybrid setups. This flexibility allows organizations to choose based on their data access requirements.

Furthermore, these systems often offer integration capabilities with other business management software such as Enterprise Resource Planning (ERP), Customer Relationship Management (CRM), Product Lifecycle Management (PLM), and Manufacturing Execution Systems (MES) to streamline operations across different departments and processes within the organization.

Difference between QMS and eQMS

The difference between a Quality Management System (QMS) and an Electronic Quality Management System (eQMS) lies primarily in their operational modes, capabilities, and efficiency in managing quality-related processes:

Operational Approach:

QMS: Traditionally, QMS may rely on manual processes, spreadsheets, or paper-based documentation to manage quality-related operations. These methods can work independently, potentially leading to discrepancies and various versions of information.
eQMS: eQMS integrates all quality management functions into a single, unified software system. It stores and manages all quality-related data in a centralized location, offering a single source of truth and reducing the risk of version discrepancies.

Data Accessibility and Security:

QMS: Paper-based or spreadsheet-centric QMS can limit access to updated documents and lack a comprehensive record of changes.
eQMS: Ensures access to updated, authorized documents, and maintains an audit trail of all changes. Unauthorized or unsigned documents are flagged, enhancing data security and compliance.

Regulatory Compliance:

QMS: Managing regulatory compliance can be challenging with traditional QMS, potentially leading to compliance issues due to manual processes and inadequate documentation.
eQMS: Provides convenience and ease in handling regulatory compliance documentation by offering features specifically designed to manage compliance requirements effectively.

Develop a Culture of Quality…

“55% of respondents who don’t own enterprise quality management software (eQMS) say their quality metrics aren’t properly measured.”- LNS Report

The effective utilization of an Enterprise Quality Management Software (eQMS) is pivotal in fostering a pervasive culture of quality within an organization. When every individual within the company embraces a quality-centric approach and resources are aligned to deliver superior products, it reinforces a culture committed to excellence.

Specifically designed to optimize various quality-related aspects in manufacturing, eQMS software ensures streamlined maintenance of factory equipment, meticulous inspection of raw materials and finished goods, and proficient handling of quality audits.

Successful eQMS implementation yields numerous benefits, including heightened product quality, reduced product recalls, minimized wastage, and fewer warranty claims, all contributing to improved operational efficiency.

eQMS systems offer robust data integration capabilities, consolidating quality-related information into a unified database. This integration drives continual improvement across the entire product life cycle.

Additionally, eQMS solutions are conveniently scalable, adapting seamlessly to the growing needs of the manufacturing organization. By eliminating departmental silos and establishing automated alerts for immediate attention to quality issues, eQMS promotes accountability.

Addressing the culture of quality, ISO 9001:2015 serves as the primary regulatory guideline, ensuring the adherence to specified quality standards across the organization.

eQMS software aligns with ISO 9001:2015 requirements, ensuring that processes, individuals, systems, resources, and final products meet the stipulated standards. This guideline outlines key characteristics for a company’s culture, emphasizing quality in business processes, workforce efforts, and the end product.

Curious how eQMS boosts quality management?”Request a Demo” now.

What are the Features of an Electronic Quality Management System?

Specific facets of total quality management require specific features to be included in the eQMS system. Below listed are the most important functions of eQMS:

Non-Conformance – It is important to identify product issues by testing for quality and eQMS helps the organization identify events of non-conformance in following the SOPs. Valid issues are considered for further actions, while invalid issues are terminated on the spot. eQMS also records all the actions taken to correct the non-conformity.

CAPA – When a non-conformance issue is identified and found to be valid, eQMS initiates the process of improvement. It specifies the corrective actions that need to be taken in terms of change in process and the preventive action required to rework/scrap the product, so that the final product quality is maintained up to the standards.

Complaint Management – The eQMS software helps manufacturing organizations establish a complaint handling process. The entire complaint management life cycle from documenting the problem, performing root cause analysis, providing timely response to the customer, and triggering internal CAPA is integrated into the eQMS system.

Change Management – When a process change is required or a CAPA issue is raised, the eQMS system manages and documents the entire change control process. It helps businesses automate the entire change management process starting from initiating change requests, impact evaluation, actual implementation, and culminating with verification and closure.

Training Management – eQMS helps organizations keep their employees updated with the latest certifications on all controlled documents in the organization. It helps manager identify training needs and keeps track of employee performance throughout the process. The eQMS software can also issue certificates on completion of the training modules.

Document Management – eQMS manages all the critical documents of the organization from creation to approval & publishing to archival. Along with updating to the latest version of the documents, eQMS also facilitates the removal of obsolete files. It can also create a master list and document map to track document changes.

Compliance Management – eQMS can help manufacturers by maintaining a clear list of compliance requirements. It automates the tracking and control of compliance-related activities like documentation, planning, reporting, audit, etc. eQMS also simplifies the reporting of non-compliance events to save the company from legislative action.

Risk Management – eQMS takes a very structured approach to identify, assess, control, communicate and review all the quality risks in the organization. With eQMS, organizations can take actions to ensure that any anticipated problems don’t occur and if they do, have a control mechanism to rectify them.

Audit Management – eQMS helps organizations conduct internal and external audits to enhance product quality. It can schedule, structure, perform and assess periodic and ad-hoc audits within the specified time frame. The audit management functionality also helps organizations meet industry-specific compliance requirements.

What are the Benefits of Electronic Quality Management Software?

An eQMS can transform the manufacturing organization in terms of men, machines, materials and methods. Below are the major benefits of an eQMS:

Enhanced Effectiveness: Clearly defining and achieving quality objectives set by the organization.
Cultivating a Quality Culture: Instilling a values-based system focused on maintaining high-quality standards across the organization.
Streamlined Data Management: Establishing a centralized database for consistent and accurate data management, ensuring a single source of truth.
Enhanced Accessibility: Enabling access to the system from multiple devices such as laptops, smartphones, and tablets.
Improved Audit Functionality: Setting tolerance levels and creating audit trails to facilitate effective audit processes.
Increased Customer Satisfaction: Adhering to quality policies and implementing streamlined processes directly impacts customer satisfaction.
Enhanced Compliance: Maintaining updated compliance records and automating alerts to ensure adherence to regulations.
Improved Documentation: Defining and documenting critical processes and objectives systematically for better clarity and understanding.

Final thoughts

eQMS focuses on the consistency of the process. It ensures that every time a production cycle is performed, the same information, material, methods, skills & controls are applied in a constant manner.

Along with heightened productivity, an electronic qms software helps prevent costly mistakes, enhance product management, improve risk forecasting and establish quality metrics. Therefore, it is important for organizations to implement an eQMS and QualityPro can prove to be a perfect choice.

Get QualityPro today and enjoy the benefits of end-to-end quality management.

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