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What is CAPA in the Pharmaceutical Industry?

Chirag Panjwani on October 19, 2023

capa-for-pharmaceutical

CAPA is Corrective and Preventive Action, holds immense significance in the pharmaceutical industry. The purpose of CAPA is to identify, analyze, and address problems by taking corrective actions and implementing preventive measures to mitigate the chances of recurrence.

In the pharmaceutical sector, where the effects of medications can profoundly impact individuals’ health and well-being, having robust CAPA capabilities integrated into a Quality Management System (QMS) is crucial.

The upcoming blog is aimed at providing comprehensive details about CAPA, with a specific focus on its role within the pharmaceutical industry. It will cover various aspects related to CAPA, including its definition, importance, processes, and implementation in pharmaceutical settings.

The blog aims to delve deep into how pharmaceutical industries can utilize CAPA effectively to ensure the safety, quality, and reliability of their products.

Table of content:

What is CAPA (Corrective Action Preventive Action)?

Corrective Action Preventive Action (CAPA) is a systematic approach used to address anomalies or inconsistencies within processes to prevent their recurrence. It’s an established system designed to ensure adherence to quality standards and regulatory requirements.

When CAPA is triggered?

As CAPA mitigates occurrence of deviations, it is triggered on encounter of a deviation. But every deviation does not trigger CAPA.

CAPA is a time taking and cost involving process, hence minor nonconformances (NCs), or deviations do not require a CAPA to trigger.

For example – If a capsule is leaked and liquid comes out of it, such severe deviations trigger CAPA.  

Another example could be of having broken/ open seal of a syrup bottle.  Deviations like these trigger CAPA.

Example where NC will not trigger CAPA – In a pharmaceutical organization, a batch of finished pharmaceutical products has labels that are slightly misaligned, but all essential information, including the drug name, strength, and expiration date, is accurate.

Such NC will not trigger a CAPA, since it is not a major issue. This can be rectified without procedural trails from the next batch.

Sources of CAPA:

A pharma industry can have various sources of CAPA, such as:

Non-conformance –

Non-conformance is deviation from standard process or product. Non- conformance is also inability to meet the standards – standard of quality or process or procedure. An NC, if neglected, eventually will lower customer satisfaction.    

For example – A capsule is supposed to be packed in double layer packaging material. QC reported that the packaging of the capsule has been a single layer packaging. This is a nonconformance in process. Hence, a CAPA triggered will have nonconformance source.

Customer complaint – When customer of a product raises complaint against a product. The CAPA raised will have source customer complaint.

For example- a patient orders paracetamol, and the company delivers anti allergic tablet, the CAPA triggered will have customer complaint as source.

Audit finding –

When the existing quality system is found unaligned with established quality system of the company, it triggers a CAPA sourced from audit.

Any good and robust pharma QMS software, like QualityPro, allows to define source of CAPA. Along with defining source of CAPA, QualityPro also allows to attach various relevant documents. This additional document helps to understand the issue, find out the cause of the issue and plan for remedies faster.

Importance of CAPA in Pharmaceutical Industry:

Corrective and Preventive Actions (CAPA) are of utmost importance in the pharmaceutical industry for several reasons:

Corrective Action and Preventive Action in Pharmaceutical Industry

Ensuring Product Quality and Safety:

The primary goal of pharmaceutical CAPA is to maintain and enhance product quality and safety. CAPA processes help identify and address deviations, non-conformities, and quality issues promptly, reducing the risk of substandard or unsafe products reaching consumers.

Regulatory Compliance:

Regulatory bodies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) have stringent requirements for pharmaceutical companies. CAPA is crucial for compliance with Good Manufacturing Practices (GMP) and other regulations. Non-compliance can lead to regulatory actions, recalls, and legal consequences.

Continuous Improvement:

Pharma CAPA fosters a culture of continuous improvement within pharmaceutical companies. By investigating and addressing root causes of problems, CAPA helps organizations identify opportunities for process improvement and efficiency gains.

Cost Reduction:

Identifying and addressing issues early through CAPA can reduce the overall cost of quality in pharmaceutical manufacturing. It helps prevent costly recalls, rework, and regulatory fines.

Documentation and Transparency:

CAPA in pharma requires thorough documentation of investigations, actions taken, and outcomes. This documentation provides transparency to regulatory agencies and auditors, demonstrating the company’s commitment to quality and compliance.

Knowledge Management:

CAPA investigations can give valuable insights and lessons regarding current and future product development and manufacturing processes. Knowledge gained through CAPA can be used to improve product designs and prevent similar issues in the future.

Steps for CAPA in Pharmaceutical Industry:

Steps in CAPA for pharmaceutical industry

Identification – CAPA starts with identification. It requires identification of all the issues that require CAPA. It also records source of the issues.

Evaluation – After identification it’s time to evaluate to decide if the issue requires CAPA or not. 

Investigation – This step is necessary to identify root cause of the issue.  Investigation includes issue identification, documentation, formation of an investigation team.

Analysis – The next step is to analyse root cause of the issue. It involves documenting data, analyse it, and find inferences for action plan.

Action plan – Make a plan which is feasible for organization to implement. The effectiveness of this step largely depends upon the correctness of previous step.

Implementation – It is about implementing the action plan decided in previous step. It requires documentation of implementation of plan, its desired output, steps, and observation.

Follow up – Once the plan is implemented, follow up will help to records and measures the effectiveness of the plan implemented.

Conclusion:

Pharma industry is very sensitive. Even a minor error and deviation in result from standard can trigger nasty repercussions. Consumers can sue the organization and regulatory organizations can put heavy penalties against the organization.

Besides monetary loss, the organizations can suffer trust depletion. In pharmaceutical sector trust is the paramount factor for any organization.

Once found erroneous, such pharma organization will struggle to gain business momentum in the market. Hence, they need to be full proof.

In such a fierce market, paper based CAPA management process is a perfect formula for errors and disaster. Having a paper based CAPA management process and Pharma QMS is as good as having no system at all.

Organizations must seek digital solutions to manage CAPA effectively. Also, to ensure quality culture in the organization, it must have a digital QMS in place.

Besides, being error prone, paper-based processes is location dependent. In the fast-paced market like today’s, organizations need a solution which is quick, fast, and anytime anywhere available.

QualityPro is one such solution for all such challenges. It is a cloud based QMS solution which digitizes and automates processes and documentation. It has a full proof CAPA management capability to check all the boxes of quality culture and compliance requisites.

With more than 2000 customers world-wide, QualityPro is an ace of spades. To know more about it, please mail us on contact@bmqualitymaster.com.

Best Practices of Quality Management for Electronic Industry

Chirag Panjwani on June 30, 2023

QMS system for electronic industries

The rapid growth of the electronic market encompasses a vast array of products and components for diverse applications, including consumer electronics, aerospace, automotive, and medical devices.

In this ever-expanding industry, electronic manufacturers face constant pressure to deliver high-performance and reliable products.

To address these challenges and optimize their quality processes, implementing an advanced Quality Management System (QMS) can prove invaluable.

This system offers electronic manufacturers the means to address their concerns effectively and streamline their quality processes.

In the following sections, this blog will delve into the best practices of quality management specifically tailored for the electronics industry.

So, read on to discover how these practices can help electronic manufacturers navigate the evolving landscape successfully.

Overview-

The electronic industry is known for its rapid technological advancements, shorter product lifecycles, and high consumer expectations. In such a competitive landscape, maintaining high-quality standards and being cost-effective is crucial and can never be overlooked.

Even a well-reputed brand like Samsung was unable to maintain high-quality product standards. In the year 2016, it faced a widely publicized issue with its cellphone device – Galaxy Note 7 model.

The consumers experienced battery defects that caused the phone to overheat and, in some cases, caught fire. The company faced a lot of criticism and their brand value at that time degraded, leaving a bad impression on the loyal customers.

But wait, this isn’t just Samsung, we can list several other electronic companies that have earlier faced some or the other quality issues that made them experience brand defamation.

The only surefire way to stay out of situations like these is consistently delivering the best quality products in the market.

Products that comply with all the ever-changing norms and fulfill the customer’s demand. Because when their needs are met, they will be more satisfied with the products and unquestionably become brand loyal.

Implementing an efficient quality management solution and adopting its best practices simplifies maintaining excellent quality at all production stages for electronic device manufacturers.

What happens when the product’s quality is always at par?

When a product’s quality consistently meets or exceeds expectations, several positive outcomes can be observed:

Quality management benefits

Increased Customer Satisfaction:

When a product consistently lives up to its quality promises, customers are more likely to be happy.

As a result, there is an increase in client loyalty, good word-of-mouth advertising, and the possibility of repeat business.

For example, when a smartphone consistently delivers excellent performance, meets user expectations, and provides a seamless user experience, customers are more likely to be satisfied.

They will appreciate the reliability, durability, and functionality of the product, leading to a positive overall experience, and thus a satisfied customer.

Strong Brand Reputation:

Consistently high-quality products contribute to building a strong brand reputation. A brand known for its superior quality gains trust and credibility among customers, leading to a competitive advantage in the market.

Apple is known for its high-quality products, and its brand reputation is built on delivering reliable and innovative devices. This reputation contributes to its strong loyal customer base, who are ready to never switch to android.

Reduced Costs:

Maintaining high product quality can result in substantial cost savings for the organization’s expenses in the long run. By minimizing defects, rework, and returns, they can avoid the expenses associated with fixing or replacing faulty products.

For example, an effective QMS system can help car manufacturers maintain strict quality control processes that can avoid costly recalls due to manufacturing defects, saving significant expenses on repairs and replacements.

Enhanced Efficiency:

Higher product quality means lesser customer complaints, reduced refund tickets, and repairs. Because of this, organizations can concentrate on other aspects such as innovation and growth, to improve the overall effectiveness of the business.

For example, a technology company can reduce the time and resources devoted to handling customer complaints and product issues by regularly delivering high-quality software updates and rapidly fixing security vulnerabilities.

Competitive Advantage:

Continuous delivery of excellent quality sets a brand apart from its competitors. It can have the capability to attract new customers who value reliability and performance and can also help in winning bids or securing partnerships in business-to-business relationships.

In a nutshell, when a product’s quality is maintained at a high level, both the company and its consumers benefit.

Best Practices of Quality Management for Electronic Industry

Best practices of QMS system for electronic industry

That said, electronic manufacturers must ensure following certain best practices that act as gateway to high quality. Here are some best practices that businesses should adopt to churn out the most from their business process and take their quality game to the next level:

Defining & Setting realistic quality goals –

To ensure consistent quality in electronic manufacturing, it is crucial to define and set realistic quality goals.

These goals should be documented, covering all production stages from component sourcing to final product testing. They should be measurable, achievable, and aligned with customer expectations and industry regulations.

Incorporating customer feedback and complying with relevant standards helps in refining and adapting the goals, while establishing measurable metrics enables progress tracking and performance evaluation.

Example: A company manufacturing smartphones may set a quality goal of producing mobile phones that have less than a 2% defect rate in their final products.

For this, they need to document the entire production cycle, determine the non-conformance and define actions to mitigate them.

Implementing Quality Control Measures:

To ensure that products fulfill the established quality standards, quality control measures should be implemented at every stage of the production process.

This comprises audits, multiple tests, and inspections at various phases, such as receiving raw materials, during manufacturing, and when they are being dispatched.

Continuous Improvement – An ongoing task:

To boost product quality and efficiency, regular activities such as evaluating processes, identifying areas for improvement, and implementing corrective and preventive actions should be done without fail.

Example: To find and address any flaws in their manufacturing process, a circuit board assembly company can regularly audit their processes and participate in ongoing training courses.

Implementing a quality management system (QMS)

A tailor-made QMS system for the electronic industry will ensure that quality standards are consistently supported and the entire quality management process from start to finish is streamlined.

Modules like document management, process control, non-conformance management, and data analysis come under its umbrella.

Not only this, but it will also help in rectifying issues and fixing them to avoid future occurrences along with staying compliant with the norms. This way, the product’s quality becomes superior, and penalties or fines can be avoided.

A QMS software solution, for instance, can help the electronic manufacturing sector to centralize its quality-related documents, monitor quality KPIs, and automate workflows for increased productivity and compliance.

Supplier Quality Management:

Maintaining product quality depends on working with verified and reliable suppliers. It will be good practice for businesses to make sure that the components and materials they receive from suppliers meet the requirements.

This could be analyzed by conducting supplier audits and performance reviews. An electronics company, for instance, can periodically evaluate its suppliers based on factors including product quality, delivery effectiveness, and adherence to legal standards.

Continuous Training and Skill Development:

It’s important to provide employees with the chance to enhance their skills to maintain quality standards. Training in quality control methods, process improvement approaches, and maintaining up-to-date knowledge of industry rules are all part of this.

For example, a factory operator at an electronics company would benefit from training in quality standards, inspection methods, and the safe handling of delicate electronic components.

Summarizing thoughts on this,

Implementing effective quality management practices is essential for success in the fast-paced and cutthroat electronic sector.

Electronic manufacturers and suppliers can uphold high-quality standards, increase customer satisfaction, and build a strong brand reputation in the market by following regulatory requirements, managing suppliers effectively, implementing total quality management, controlling manufacturing processes, conducting extensive testing and validation, encouraging continuous improvement, engaging employees, and maintaining thorough documentation.

Adopting these best practices will aid the electronic industry’s long-term success and expansion. One quality expert that can help you in adhering to all of it is QualityPro.

This powerful, scalable, and robust TQMS software can help you instill a quality culture in your organization. So, get in touch with our experts now.

Top 10 Quality Management System Trends to Watch in 2024

Chirag Panjwani on June 2, 2023

According to a report, the global quality management software market size was valued at USD 9.37 billion in 2022 and is expected to record a compound annual growth rate (CAGR) of 10.6% from 2023 to 2030.

The figures clearly indicate that due to the growing consumer awareness and demand for quality, more and more manufacturers are turning towards adopting this digital approach of maintaining “Quality” in their products.

The QMS Software market saw a slump in its growth, during pandemic, owing to financial restrictions. But, since the market has recovered to its original strength, organizations are more vigilant to serve the quality-seeking customers just what they need.

Moreover, the manufacturers are even focused on enhancing sustainability practices into their routine operations with a supreme goal of reducing waste and carbon footprint.

These and many such factors have set the base for QMS trends that will rule 2024.

So, the quality management strategy of the manufacturers seeking one should be based on the trends that are mentioned ahead in this blog.

Top 2023 Trends in Quality Management System

Increased Adoption of Lean Six Sigma-

The combination of these two fundamentally sound methodologies- Lean Manufacturing and Six Sigma, is taking a front stage these days.

Reason? It provides a streamlined framework to businesses to incorporate an improvement strategy focusing on managing

1. The flow of materials and crucial information between the processes,

2. Minimizing waste,

3. Addressing and removing the no-value-adding tasks.

This in turn helps bypass challenges like meeting customer expectations, cutting costs pressures, improving profits, and reducing lead times.

Aren’t these reasons enough to crown adoption of lean six sigma a top QMS trend of 2024.

Adoption of Lean Six Sigma

Growing Cloud Technology-

Businesses, to excel today must have flexibility, scalability, and transparency.

Holding on to the on-premises software solutions with huge infrastructure maintenance cost, slow performance, pending updates, location-dependent services, and much more, could be detrimental.

On the contrary, having remote and faster accessibility to all data, ability to collaborate multi-locations and multi-sites, scalability to new needs and norms and such capabilities ensure business not just survive but thrive in this digital world.

These capabilities are offered by Cloud-Solutions, and this makes it yet another top trend of 2024.

Increased Focus on Supplier Management-

Poor supplier performance impacts an organization’s product quality, finances, time, customer base, brand image in the form of lost sales, costly recalls, penalties for non-conformance, etc.

Thus, upgrading and maintaining the supplier quality—by partnering the suppliers capable of meeting regulatory & safety standards, would be an unavoidable trend to eye on.

Managing Cyber Security Risks-

In the era of tech dominance, cyber risks have become a major concern, specifically for the manufacturers that are data-dependent.

Hence, enhancing security to safeguard trade secrets like formulas/recipes, crucial documents and gaining complete operational control, etc., would be one of the major goals of the manufacturers this year.

More Transparent Production-

Consumers are increasingly interested in knowing about the items they purchase than ever before due to increased concerns about food safety, ethical sourcing, data security, and environmental impact.

“According to research, 94% of consumers are more likely to be loyal to a brand that offers complete supply-chain transparency, while 39% say they’re willing to switch to a more transparent brand.”

As a result, manufacturers will seek to implement robust tracking capabilities across their supply chains. Thus, from inception to consumption, 100% transparency will be a prominent trend this new year.

Prioritizing Quality Culture-

For a successful quality management program, quality culture is of paramount importance.

People often consider that only records, SOPs, and documentation, govern the ideology of “quality.” However, these factors account for 20–30% of maintaining quality.

The quality culture and mentality that you introduce within the organization will ensure that individuals truly adhere to the SOPs, comprehend them, and internalise them.

Hence, in 2024, instilling a culture of quality by deploying a good quality management software that allows the user to do the job right, will be a trend.

Making data-driven decisions-

What separates a thriving business from a declining one is the quality of decisions the management makes. And data proves to be the key to sound decisions.

For this, having a QMS software that offers robust functionalities like real-time view and operational insights of the business, helps manufacturers make data-driven decisions.

More Effective Training Programs-

A successful quality management program not only depends on improving processes using Quality Management Systems, but also enhancing involvement of and upskilling employees.

Hence, to accomplish the goal of delivering high-quality products and services, businesses need to invest in building effective training programs for their employees to reduce the possibilities of error— thus fixing a place in the top trends this year is Training Programs.

Better Audit Preparedness-

With an increase in globalization and technology, the manufacturing sector has become more vulnerable to the risks. Moreover, with time, even the norms and norm-makers have become stringent and stricter.

That said, performing manufacturing audits actually help identify the gaps, gain useful business insights, and improve company’s future performance.

And staying ready for such audits is not just a trend but a good business practice.

A Comprehensive Solution-

The world is coming on a platform called technology. Integrated solutions are the norm. We agree that best-of-breed software have better capabilities, but they come with a potpourri of drawbacks-

  • 1. Inconsistent workflow
  • 2.Increased time in integrating data
  • 3. Extra cost due to multiple implementations & maintenance
  • 4. Disconnected and spilled data 5. Errors and lag in data retrieving

An integrated solution, quite like a QMS with all-essential modules, on the contrary keeps the entire organization on a common platform.

It provides real-time, unified, and precise data without the need for uploads and downloads. These benefits have won a place for an integrated and unified QMS Software in prominent trends this year.

Final Words-

Though the impact of the above-mentioned trends could be different for different organizations but, making the right choice of the solution would be the defining factor in terms of growth & productivity.

One such solution that proves competent to all the quality management requirements even during the changing market trends is the QualityPro.

Being a next-generation, cloud-based software, it helps manufacturers streamline the key quality management processes—ensuring quality throughout the product lifecycle.

Difference between QMS and ERP: Key Aspects and Functionalities

Chirag Panjwani on March 17, 2023

QMS vs ERP system

Comparing QMS Software (Quality Management System) and ERP Software (Enterprise Resource Planning) is akin to contrasting apples and oranges. Both fall into the broader category of business software, yet their functions and importance diverge significantly, crucially enhancing businesses by streamlining operations in different ways.

Discover more about their unique capabilities, distinct features, and interconnectedness. The surprising conclusion might reveal an unexpected synergy between these two essential systems. Keep reading to explore their differences and their surprising connection!

Overview:

Businesses of all sizes and types can use QMS and ERP software. QMS software is crucial for companies that operate in highly regulated environments such as healthcare, aerospace and defense, the automobile industry, food and beverage industry, etc. Since these organizations typically have to abide by quality standards and rules like ISO 9001, they require a software solution to monitor and record their quality processes.

On the other side, businesses of various sizes, industries, and sorts need ERP to automate and streamline their operational procedures from start to finish along the complete supply chain. ERP software can help businesses make better decisions, and boost productivity and profitability to have a unified perspective of their business operations.

However, businesses often get confused if they should implement an enterprise resource planning system or deploy a standalone quality management system. As the features of these systems frequently overlap, there may be discussions among companies who have already implemented both systems over which system best meets a certain functional requirement.

But the key is, when it’s about managing the processes of regulated industries, it’s important for manufacturers to deploy a solution that can oversee quality and is also suitable for their regular business operations, procedures, and outputs. It should be a blend of the quality and their supply chain functionalities.

What is a QMS?

A formalized system that documents processes, procedures and responsibilities for carrying out quality policies and objectives is known as a quality management system (QMS). A QMS helps in organizing and directing an organization’s operations to satisfy the customer and regulatory requirements and continuously enhance effectiveness and efficiency.

Benefits of QMS:

  1. Streamline and automate end-to-end business operations
  2. Centralize data for a single source of truth
  3. Rapid responses to critical business issues
  4. Gain comprehensive business insights
  5. Accelerate company and financial reporting processes
  6. Ensure compliance with legal requirements through enhanced visibility
  7. Unified platform for data storage and integration with shared databases
  8. Optimize stock levels and inventory management
  9. Efficient warehouse management to support operations

What is ERP?

Enterprise resource planning (ERP) is a modular business management software that organizations use to manage day-to-day business activities such as accounting, procurement, project management, human resources, compliance, and supply chain operations, etc. A complete ERP software suite includes enterprise performance management, planning, budgeting, predicting, and reporting on an organization’s financial health.

ERP systems allow for the exchange of data between various business processes and bind them all together. They avoid data redundancy and ensure data integrity with a single source of truth by gathering an organization’s shared transactional data from several sources. The new-gen ERPs are available on different platforms- cloud ERP, on-premise ERP, and hybrid ERP.

Benefits of ERP:

  1. End-to-End Process Optimization: Streamline operations from start to finish
  2. Unified Data Repository: Obtain a reliable single source of truth
  3. Rapid Decision-Making: Prompt responses to critical business issues
  4. Comprehensive Analytics: Deeper insights for informed decisions
  5. Accelerated Reporting: Expedite company and financial reporting
  6. Enhanced Compliance: Maximize visibility to meet legal requirements
  7. Centralized Data Platform: Single platform for data storage and integration
  8. Optimized Inventory: Improved stock levels and control
  9. Efficient Warehousing: Streamline warehouse management operations

Key Functionalities of ERP & QMS:

Here’s more clarity on the type of modules these software offers:

Major difference between ERP and QMS Modules

Difference Between ERP and QMS

Difference between ERP and QMS System

The Potential of Combining QMS & ERP

Disparate systems and quality control procedures can rapidly silo crucial enterprise as well as quality data, resulting in complexity, limiting visibility and standards, both inside and between the facilities.

An ERP solution can enable enterprise integration and meet a variety of manufacturing needs. And a QMS can ensure quality at each step. However, adoption of integration of an ERP system and a QMS, will make it possible for the two systems to communicate with one another and exchange data, seamlessly, reducing duplication and delays associated with manual upload and download.

And so, to compete, expand, and innovate, manufacturers should adopt a cloud-based enterprise resource planning system with quality management features.

  • Integrating the two softwares can help businesses automate quality workflows into operational processes resulting in thorough application of quality processes across the entire supply chain cycle.
  • Improvement in quality and compliance drives the ability to standardize, streamline and simplify processes.
  • Businesses can predict trends and risks on the company by analyzing real-time data stored centrally which will drive them towards continuous improvement.
  • By automating quality procedures, it becomes possible to promote and apply best cGMP practices in all operations that enhances the quality of the final output.
  • QMS and ERP together speed audits and keep manufacturers away from legal obligations and fines without compromising on quality.
  • Streamlining workflows and synchronizing them between quality and manufacturing reduces cycle times, throughput value and resource requirements.

Combining a QMS and ERP system can result in improved data accuracy, better collaboration, increased efficiency, enhanced visibility, and improved compliance. By leveraging these benefits, manufacturers can drive performance improvements, respond more quickly to changing market conditions, focus on innovation, preserve capital and remain competitive in a rapidly evolving industry.

Summarizing thoughts

Understanding the needs of the business and all the associated functional groups is essential to choose the best solution. In light of the needs of the business, the capabilities of the various systems must be assessed.

The focus should be on the actual demands of the business rather than personal preferences or previous experiences. It’s crucial to determine and document the needs of each functional group participating in the business process, and to obtain their explicit agreement that this document fully and accurately satisfies those demands.

The true capabilities of both systems can be evaluated through research and vendor demos. With a clear understanding of the capabilities of each system, companies can weigh the pros and cons of various approaches.

It is critically important that all the individuals involved strive to be objective and reach consensus across all functional groups. So, it completely depends on the need of businesses that they want to integrate the system or want to use it as a standalone.

If you still have any questions about it, we would be pleased to help. Contact us by sending an email at sales@tecwrk.com  with any questions or requests for a demo.

What is Non-Conformance Software?

Chirag Panjwani on February 16, 2023

What is non conformance management system

What if a food processing plant finds that the packaging of one of its products was contaminated with bacteria during production? Or, the pharma company finds that the manufactured drug batches have the wrong dosage prescribed.

In situation like these, the possible consequences that might come across the manufacturers will be – re-work on the product, scrapping out the wrong ones, time & resource wastage and many a times wrong word of mouth for the brands which could also lead to unsatisfied customers and legal penalties.

Long story short, inability to determine non-conformance is the whole-sole reason manufacturers face situations like these. Keep on reading the blog to explore what it is and how manufacturers can prevent themselves from sliding into situations like these.

Table of Contents:

  • What is Non-Conformance?
  • What consequences does non-conformance have?
  • Non-conformance management as per ISO 9001 standard
  • Tips for mitigating non-conformance
  • How to tackle Non-Conformance?

What is Non-Conformance?

Non-conformance is an indication that a service, process, product, or even the system has went wrong because it didn’t meet a specified set of requirements. A non-conformance indicates that a company’s standard operating procedures perhaps need to be modified or updated in some ways, or both. These deviations can be identified by conducting internal and external audits, analyzing customer complaints, material inspection or routine testing.

After that, a non-conformance report is created. A Non-Conformance Report provides structured documentation of the specifics of a Non-Conformance found. As a result, entities, initiatives, or individuals that fall short of the required standards in terms of quality and safety may be held liable.

This report’s objective is to record the specifics of a departure from expectations. This report assists management in providing a clear and logical definition of the issue so that appropriate steps can be taken to accomplish the desired improvements.

A non-conformance management software ensures that each non-conformance is accurately recorded and addressed with. It helps businesses in upholding quality standards and fostering growth. The module can function independently or in conjunction with our other quality control software.

What Are the Different Types of Non-Conformances?

Basically, there are two categories of non-conformance:

  • Minor Non-Conformance

Minor non-conformance arises on a small level and doesn’t affect the whole company. Therefore, this kind of nonconformance has small repercussions and is much simpler to resolve. For example, small fixes in product manuals. This can easily be fixed by updating the relevant documentation.

A minor non-conformance is typically not a big deal and is easy to fix. Minor non-conformances could, however, grow bigger if they are neglected. Businesses should have systems and processes in place for recognizing and resolving non-conformances in order to prevent minor issues from developing into serious ones. Some more examples of non-conformance are:

  • Multiple violations of requirements.
  • Multiple missing/unsigned documents
  • Improper machine calibration
  • Major Non-Conformance

The entire production or workflow of the company is significantly impacted by a major non-conformance. The end product could be significantly degraded by serious non-conformance issues. Things like untested items or making unauthorized, unapproved changes to the production without documenting, monitoring and communicating the impact of changes are examples of serious non-conformance.

A major non-conformance can have a significant negative impact on a company’s or organization’s reputation and brand. These are more challenging, expensive, and time-consuming to fix than a minor non-conformance. Therefore, tools and processes that are effective in identifying and resolving serious non-conformances before they have a negative impact on their operations are essential.

What consequences does non-conformance have?

If non-conformances are not identified and handled on time, they can create chaos and havoc. For example, failing to address a change to all the concerned departments may lead to incorrect functioning of your employees and thus processes going haphazard. The morale of your organization can suffer as a result of persistent personnel actions that violate ISO 9001 criteria.

Additionally, manufacturing goods that don’t meet criteria can invite rework, scraping, even product recalls, legal suits and what all follows this is obvious. But these consequences can be possibly reduced with the help of a Non-Conformance Management Software.

Non-Conformance Management Software

Non-conformance management as per ISO 9001 standard

The management of these events can be connected to any of the current ISO standards, with ISO 9001 being one of the most popular. In order to constantly enhance operations, improve the quality of output, foster efficiency and competitiveness, and increase customer satisfaction, numerous industrial enterprises have embraced the globally recognized ISO 9001:2015 quality management system.

Failure to adhere to the technical specifications of the products (characteristics, materials, operation, etc.) or of the processes results in the majority of non-conformances within an ISO 9001 management system (delays in delivery times, errors in quantities, human failure due to lack of training, inadequate use of equipment, etc.).

ISO 9001 Non conformance examples

Tips for mitigating non-conformance

It is crucial to set up suitable procedures and vital measures intended to stop Non-Conformance before it occurs. To do this, there are a number of actions to followed:

  • Finding the non-conformance

A non-conformance can be found by any organization’s  stakeholder, including customers, internal employees, suppliers, external auditors, and public administration. This must be disclosed as quickly as possible, whether it occurs via internal or external audits, quality controls, or analysis of consumer complaints or claims.

It is crucial to accurately describe the non-conformance during this initial stage of the process and to provide information, such as the proof that the non-conformance occurred, the document outlining what should have been done but wasn’t, the time and individual who discovered the non-conformance, etc.

  • Resolution of the non-conformance

Once the non-conformance has been identified and thoroughly documented, it must be fixed in order to quickly resolve the issues and the reason that caused it. The work is not finished yet; as it might not be a one-time issue and is can spring-up often; thus, it will be important to address the core cause.

  • Detection and investigation of the non-conformance’s root causes

In order to prevent future replication of the non-conformance, this is a crucial step. There are various effective approaches, such as the problem analysis and resolution tool, for identifying and treating the root cause (there may be one or more than one).

  •  Planning and implementing corrective measures to eliminate the issue

Once the underlying reason of the non-conformance is identified, businesses can take one or more corrective measures to mitigate it, take charge of implementing those measures and decide a timeline for doing so.

  • Verification of the corrective action

The effectiveness of the corrective activities put in place will be determined in this final stage, which is one of the most crucial ones. Check that the deviation no longer occurs as soon as a circumstance identical to the one that caused the non-conformance surfaces.

Remember to solve the problem until you can confirm with absolute certainty that the remedial measure is working.

How to tackle Non-Conformance?

Implementing a Non-Conformance Software or a QMS system integrated with NC module can help you track non-conformances, identify the core issues and speed up the process of implementing the corrective actions in the business operations.

With QualityPro NC/CAPA modules, businesses can obtain real-time data to detect non-conformances at the earliest and minimize their potential impact. In addition, they can have detailed information and tools for root cause analysis of the non-conformance and take corrective and preventive solution to eradicate it and never let the issue occur again.

With this solution, companies increase the agility with which they make decisions and execute corrective actions; experience improved competitiveness and customer service levels; reduce non-quality costs, and comply with the company’s continuous improvement strategy.

Want to make Non-Conformance Management easier, faster, and more structured?
Deploy QualityPro now!! For more details, visit https://www.bmqualitymaster.com/contact-us/ or mail at: contact@bmqualitymaster.com