Chirag Panjwani - TecWork

Simple Guide to SOP Management in Pharma Industry

Chirag Panjwani on November 22, 2023

The complexity of manufacturing, especially in the pharmaceutical industry, is multifaceted and significantly high. The direct impact of pharmaceutical products on consumer wellness and health necessitates an unwavering commitment to getting it right every time.

Standard Operating Procedures (SOPs) Management, a fundamental framework that not only delineates the standardized steps and processes but also stands as a mandatory compliance requirement in the industry.

SOPs serve as a vital blueprint, offering clarity and guidance for both seasoned professionals and newcomers within an organization. For newcomers, in particular, SOPs act as a foundational resource, facilitating their assimilation into the organizational culture, functions, and processes with utmost clarity, leaving no room for confusion.

Looking to streamline SOPs in pharma? “Request a Demo” today.

The upcoming blog aims to delve deep into the world of SOPs in pharmaceutical industry, providing comprehensive insights into their significance, implementation, and impact.

Stay tuned to uncover a detailed understanding of SOPs and their pivotal role in ensuring quality, compliance, and efficiency within pharmaceutical manufacturing.

Table of Content:

What is SOPs in Pharma Industry?
Why Pharmaceutical SOPs are Important?
Benefits of SOP in Pharmaceutical Industry
Factors Important for Establishing Guidelines for SOPs in Pharma
How to Manage Pharmaceutical SOPs?
Final Points

What is SOPs in Pharma Industry?

SOPs (Standard Operating Procedures) is crucial in the pharmaceutical industry to ensure tasks are carried out consistently, accurately, and in compliance with regulations.

Here’s an example list of protocols for entering a laboratory in a pharmaceutical organization:

Personal Protective Equipment (PPE): Before entering the lab, ensure you’re wearing the designated PPE, such as lab coats, safety goggles, gloves, and closed-toe shoes.

Hand Hygiene: Wash hands thoroughly with soap and water or use provided hand sanitizers to maintain cleanliness.

Authorization and Access: Only authorized personnel with proper credentials and training are allowed entry. Access control measures must be adhered to strictly.

Equipment Check: Before commencing work, ensure that all necessary equipment is in working condition and calibrated if required.

Documentation Review: Review and understand the specific SOPs related to the tasks to be performed in the lab.
Waste Disposal Procedures: Familiarize yourself with the proper disposal methods for various materials, including hazardous waste, sharps, and general waste.
Chemical Handling: Follow established procedures for handling, storage, and disposal of chemicals, including appropriate labeling and Material Safety Data Sheets (MSDS).
Emergency Procedures: Understand emergency protocols, including the location of emergency exits, eyewash stations, fire extinguishers, and emergency contact information.
Cleanliness and Organization: Maintain cleanliness and organization within the lab space, ensuring all work areas are tidy after use.
Sampling and Contamination Prevention: Adhere to specific procedures for sample collection, avoiding cross-contamination, and maintaining a sterile environment when necessary.
Equipment Log: Maintain a log for any equipment used or experiments conducted, noting details for reference and traceability.
Report Any Anomalies: Immediately report any accidents, spills, equipment malfunctions, or deviations from procedures to the designated authority.

These rules show the careful and organized steps needed before going into a pharmaceutical lab. Each step is really important to make sure everything is safe, follows the rules, and keeps the experiments or work in the lab reliable.

The example is not an ideal one, but it can give you a fair idea of what it actually is. Likewise, for every process, there are set rules, documented, approved, and verified which are known as SOP.

QualityPro, an eQMS (Electronic Quality Management System) Software provides a comprehensive solution for organizations to centralize and manage all SOPs in a single, accessible location. Its Advanced SOP in pharma functionality allows for the maintenance and management of Master SOPs and associated records efficiently.

Why Pharmaceutical SOPs are Important?

As stated earlier, SOPs lay down a blueprint for necessary actions to be taken while performing a task or following a process. Let us discuss why SOPs are so important for a pharmaceutical industry:

Standard Operating Procedures in Pharmaceutical Industry

Regulatory Compliance: Compliance with regulatory standards is essential in the pharmaceutical sector. Documented SOPs ensure that processes align with regulatory requirements. Regulatory organizations inspect SOPs to verify adherence, and any deviation or absence of SOPs could lead to severe penalties or regulatory actions.

Consistency in Procedures: Maintaining consistency in manufacturing processes is critical. SOPs ensure that each drug batch is produced with the same procedures, facilitating consistent results and effects on patients. This consistency is fundamental for ensuring the safety and efficacy of pharmaceutical products.

Enhanced Efficiencies: SOPs are dynamic documents that evolve with industry advancements. Continuous improvements and updates to SOPs enhance the efficiency of processes. These improvements contribute to better quality products and streamlined operations.

Responsibility Delegation: SOPs clearly outline roles and responsibilities for various procedures. This delineation reduces overlap and ambiguity, ensuring that everyone understands their job roles and responsibilities, promoting accountability and awareness among staff members at all levels within the organization.

Absolutely, defining job responsibilities within SOPs not only streamlines processes but also contributes to cost savings and maximizes individual potential within an organization.

Benefits of SOP in Pharmaceutical Industry

Performance Evaluation and Planning: SOPs provide a benchmark for assessing personnel performance. Managers can easily evaluate adherence to SOPs, ensuring standards are met. Employees, armed with SOPs, can plan their work schedules more effectively, knowing the standards they’re expected to achieve.

Scalability and Consistency: As organizations grow or expand across multiple facilities, maintaining consistent output becomes critical. SOPs ensure uniformity across all sites by standardizing procedures, enabling each facility to produce the same quality results, crucial for maintaining consistency in pharmaceutical products.

Knowledge Continuity and Transfer: SOPs act as a repository of knowledge. In instances where key personnel depart, the documented SOPs become invaluable resources, ensuring that critical knowledge and procedures are preserved. This helps prevent disruptions and ensures that operations continue at the same standard even in the absence of key individuals.

Effective Training Tool: SOPs serve as comprehensive guides for newcomers. Instead of relying on scattered or incomplete information from colleagues, new recruits can refer to SOPs for precise and detailed procedures. This minimizes confusion, errors, and ensures that newcomers receive accurate and consistent information during their training.

In essence, SOPs not only standardize processes but also serve as crucial tools for performance evaluation, scalability, knowledge transfer, and effective training within the pharmaceutical industry. Their multifaceted role significantly contributes to operational efficiency and consistency.

Factors Important for Establishing Guidelines for SOPs in Pharma

Developing comprehensive guidelines for SOP is quite crucial to ensure consistency in product and regulatory compliance.

Consider the following factors while formulating the SOPs of your pharmaceutical organization:

Uniformity and Standardization: Consistency in format, structure, language, and style across all SOP documents ensures clarity and promotes effective communication within the organization. This uniformity facilitates ease of understanding for all stakeholders.

Legal and Regulatory Compliance: Adherence to legal and regulatory requirements is non-negotiable. SOPs should incorporate specific measures and guidelines to ensure compliance with these obligations, maintaining the highest standards of quality control.

Clarity and Simplicity: Avoid complex technical language in SOPs. Using straightforward, action-oriented language in an active voice makes procedures easier to understand and follow, benefiting all personnel involved.

Comprehensive Content: SOPs should leave no room for guesswork. They should contain exhaustive information, detailing procedures, timelines, and quality standards precisely. Including even the minutest information ensures thoroughness and clarity.

Stakeholders’ Involvement: Involving key stakeholders, such as department heads, process heads, and IT heads, in the SOP development process is essential. Their input ensures practicality and relevance in the guidelines, aligning them with actual operational needs and challenges.

By considering these factors, a pharmaceutical organization can develop SOPs that are not just compliant but also comprehensive, clear, and practical for effective implementation across the organization. These SOPs serve as critical documents guiding personnel in adhering to standardized processes and maintaining the highest quality standards.

How to Manage Pharmaceutical SOPs?

SOPs once drafted, verified, and approved must be stored and kept secure in a quality management software for pharma industry like QualityPro.

Pharma SOP software offers a host of management capabilities to effectively access, manage, edit, and secure all the SOPs of the pharmaceutical organization.

QualityPro offers a robust set of capabilities for effective management of SOPs within a pharmaceutical manufacturing industry:

Advanced SOP Functionality: This feature allows the maintenance of master SOPs and their corresponding records. It provides a structured system for sorting, accessing, and categorizing SOPs, ensuring organized and efficient management.
Access Control: QMS system ensures controlled access to SOPs, permitting entry only to authorized personnel. This access control adds an additional layer of security against data breaches. Moreover, it allows for specific controls over viewing, editing, or other actions based on job roles, enhancing data security.
Stamping for Tracking: The QMS solution offers user and date stamping, creating a comprehensive trail of who accessed or utilized the SOP and when. This tracking capability ensures accountability and traceability within the system.
Guideline Attachment: QualityPro allows the attachment of supplementary documents, guidelines, or rules to SOPs. This feature enhances clarity and management of SOPs by providing additional context or explanatory materials, ensuring comprehensive understanding and effective implementation of procedures.

These functionalities collectively contribute to a robust and secure system for managing SOPs, ensuring compliance, security, and traceability within the pharmaceutical industry.

Final Points –

SOPs in pharmaceutical industry play a critical role as the backbone of pharma manufacturing, dictating standardized procedures and ensuring consistent, reliable results. Mismanagement, uncertainty, or scattering of SOPs can lead to chaos and deviations in outcomes, which is particularly impactful and risky in the pharmaceutical industry.

In this context, effective management of SOPs becomes paramount for pharmaceutical manufacturers. QualityPro takes on this challenge robustly by offering comprehensive solutions to manage, track, store, secure, revise, and distribute SOPs in the most effective and efficient manner.

For pharmaceutical manufacturers grappling with SOP management challenges, QualityPro provides a reliable solution. By clicking here, organizations can streamline their SOP processes, ensuring adherence to standards, regulatory compliance, and the maintenance of top-notch quality in pharmaceutical operations.

QualityPro’s tailored capabilities aim to alleviate the complexities associated with SOP management, enabling pharmaceutical organizations to uphold the highest standards and achieve operational excellence without compromising on regulatory compliance or product quality.

What is CAPA in the Pharmaceutical Industry?

Chirag Panjwani on October 19, 2023

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?
When CAPA is triggered?
Sources of CAPA
Importance of CAPA in pharmaceutical industry
Steps for CAPA in pharmaceutical industry
Conclusion

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. Contact us to know more about it, or mail us on sales@tecwrk.com.

Best Practices of Quality Management in Electronics Manufacturing

Chirag Panjwani on June 30, 2023

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.

Looking for a digital solution? Explore our “QMS software for electronics industry“

In the following sections, this blog will delve into the best practices of quality management in the electronics manufacturing 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 in Electronics Industry

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 organisation’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, organisations 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.

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

Best Practices of Quality Management in 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 in 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 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 analysed 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 by TecWork.

This powerful, scalable, and robust eQMS software can help you instill a quality culture in your organization.

Looking to improve quality practices in electronics manufacturing? “Contact Us“

Difference between QMS and ERP: Key Aspects and Functionalities

Chirag Panjwani on March 17, 2023

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:

Streamline and automate end-to-end business operations
Centralize data for a single source of truth
Rapid responses to critical business issues
Gain comprehensive business insights
Accelerate company and financial reporting processes
Ensure compliance with legal requirements through enhanced visibility
Unified platform for data storage and integration with shared databases
Optimize stock levels and inventory management
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:

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

Key Functionalities of ERP & QMS:

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

Difference Between ERP and QMS

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.

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 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.).

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.