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The Benefits of Quality Management Systems: Why You Need a QMS?

Chirag Panjwani on December 12, 2024

Benefits of quality management system

Quality is a diversified term used in day-to-day life! Whether it’s the products we purchase or the services we seek, our chief expectation is excellence in the quality.

An old business saying that persists till today- “Success of any business/organization hinges on these three pivotal elements: Price, Service and Quality”. Nevertheless, the underlying truth is that businesses find it challenging to achieve all the three simultaneously.

Striking a balance is intricate, as efforts to emphasize price and service often come at the expense of quality, and a focus on service and quality may impact pricing.

One way of ensuring that all the three factors co-exist is possible by adopting a Quality Management System.

A Quality Management System is a set of standardized procedures and policies that provides a structured approach to quality management, eliminating risks and improving processes organization wide.

How Quality & Standardization Came into Existence?

The roots of the term “Quality” can be traced centuries back when the Industrial Revolution took place. Earlier, only the standards that control the processes and products were used in the form of quality management systems.

Later, as the organisations and production quantities grew, the need for best practices, to ensure quality results, was felt.

Eventually, best practices for controlling products and processes were established and documented, which turned into standard practices and termed as “Quality Management System.”

It is also believed that the need of Quality Management became increasingly important after the World War II. This was the time when, bullets and rifles used to be manufactured in separate states.

So, to ensure their effectiveness and compatibility, without sacrificing quality, armed forces started incorporating best practices into their production and performing inspection using quality techniques.

Over the time, concerning the safety of consumers, a certification was developed under the name ISO 9001. Before getting this certification, a company needs to undergo an assessment by the third-party certification authoritative body, to ensure that organization is strictly adhering to these standard processes, procedures, and activities, maintaining quality management.

This helped them ensure quality, consistency, and accuracy throughout the production.

Still wondering how does a Quality Management System benefits organizations. Read on the remaining half part of the blog to know-

Explore the Unconventional Benefits of a Quality Management System

Benefits of quality management system

Fostering Consistency & Transparency-

A Quality Management System works justifying the phrase “Do what you documented and document what you do”, ensuring that every process is properly documented. This includes creating comprehensive documents, mentioning clear quality standards, such as Standard Operating Procedures (SOPs), work instructions, and guidelines etc.

This ultimately streamlines and standardizes the workflow, ensuring every step is executed with consistency, across the organization.

Reduced Defects & Improved Product Quality-

A Quality Management System categorizes various documents, and ensures that all the processes are being performed adhering to the set quality standards. This ultimately leads to minimizing the chances of errors and defects, improving the quality of the outcome.

Moreover, incorporating the practice of regular audits, inspections, and monitoring processes on various quality parameters, a Quality Management System helps to identify deviations (NCs), perform root cause analysis using the methods like Five Whys, Fishbone Diagram, Flow chart, Pareto chart, etc., so that corrective actions can be taken to prevent recurrence of issues.

Improved Communication-

A Quality Management System maintains a centralised repository of all the documents, including procedures and work instructions. This ensures that everyone has same information, and all the employees have a clear understanding of their roles and responsibilities, eliminating miscommunication and confusion.

Increased Customer Satisfaction-

Adopting a Quality Management System helps establish a culture of quality throughout an organization, right from top-level management to front-line employees. This ensures organizations to be customer centric, focused on fulfilling all the needs of customers.

Additionally, by offering a comprehensive solution, right from registration to resolution of complaints along with designating their source, priority, and severity, a QMS helps retain customers and increase sales.

Operational Efficiency and Cost Savings-

As discussed, since processes will be documented and standardized, workflow will be streamlined. Consequently, there will be less room for error, contributing to reduced wastage, increased cost savings, and enhanced operational efficiency.

Swift Risk Resolution-

The proactive approach of a Quality Management System to ensure that standardized processes are regularly followed across the organization helps identify, assess, and create a framework of steps to mitigate the risks related to compliance, safety, and product/service quality.

Assurance of Skilled Workforce-

A Quality Management System streamlines the complete training process right from helping identify the training requirements, maintaining record of trainees, scheduling sessions, execution, to evaluating performances. This type of comprehensive approach ensures that every employee stays updated by continually improving skills.

Additionally, it also aids organizations in assigning specific roles to specific individuals based on their results, minimizing the likelihood of errors.

Need to Switch to Quality Management Software-

However, a Quality Management System that relies on manual intervention becomes error-prone and time-consuming, resulting in inefficient operations. To avoid this, a Quality Management Software was developed.

It is a technological platform that allows to perform all the quality related operations and manage business crucial documents, digitally!

This tool automates and simplifies the core quality management processes involving:

  • Document management
  • Risk management
  • Training management
  • Complaint management
  • Audit management
  • SOP management
  • Inspection
  • Non-conformance management, etc.

Final Thoughts-

Adopting a Quality Management System (QMS) brings numerous benefits, fostering a culture of quality and continuous improvement within the organization. However, these advantages remain out of reach if quality management processes rely on outdated, manual methods.

To unlock the full potential of a QMS, digitization is essential—and that’s where a robust Quality Management System Software comes into play.

The real challenge lies in selecting the ideal QMS that offers all the essential features and aligns with your organization’s needs. Enter QualityPro—a cutting-edge, technologically advanced software crafted to digitize and optimize your quality management processes.

Packed with powerful modules, this next-gen, cloud-based solution ensures your organization stays ahead in maintaining and elevating quality standards.

No matter your industry, QualityPro by TecWork transforms your quality management program, making it more efficient and impactful.

Have questions about implementation? Our team of experts is here to help. Contact us today and take the first step toward revolutionizing your quality management system!

All You Need to Know About Quality Audits in the Pharmaceutical Industry

Chirag Panjwani on November 7, 2024

Audit management system for pharmaceuticals

Quality audits are very crucial in checking compliance with regulatory requirements in any industry. In a pharmaceutical setup, these audits check whether the complex processes and procedures of your pharmaceutical unit follow the set standard.

For examples, let us assume that your pharmaceutical company is making paracetamol to sell in the market. It is only through quality audits that your consumers, and regulatory bodies will have assurance that quality of your product meets the standard and therefore they are safe and effective to use.

Quality audits are very complex and time taking process.  But if you know how to prepare for quality audits, and how to be prepared for an audit, most of your worries will go away.

So, in this blog we will discuss all that you need to know regarding quality audit in pharmaceutical industry and will look into the ways to prepare for your next or probably the first audit.

What Is a Pharmaceutical Quality Audit?

Pharmaceutical quality audit is the systemized examination to check if your pharmaceutical organization follows the processes and procedures which are compliant to set standards. It also examines if the pharma company is producing products which match the set quality standards.  

These quality audits also give feedback to the organization and find out the scope of improvement in process, procedures, or quality of the product to meet the standard of the market.  

The entire motive of any pharmaceutical quality audit is to verify if the products being manufactured by the organization are safe to use for consumers or not.

Types of Audits in the Pharmaceutical Industry

Pharmaceutical industry will have three types of audits:  

  • Internal audit
  • External audit
  • Unannounced audit

Internal Audit – as an organization you audit your facilities, SOPs, other procedures frequently.  Internal audits help to keep the day-to-day work and procedures smooth and without flaw.

With the help of an audit management system, like QualityPro’s QMS software for pharmaceutical industry, you can plan internal audits by managing audit schedules, creating regular assignments, and sending out notification to the right set of people.

External Audit– External audits are conducted by external parties. It can involve independent organization, like notified bodies and authorities. With the help of a pharmaceutical audit management system like QualityPro, organizations can easily conduct external audits, make reports, and send recommendations, if any, for further improvement.

Unannounced audits– Unannounced audits can be conducted randomly by organizations or third parties. The more complex is your manufacturing product, the more frequent can be such unannounced audits.  

These are generally conducted to ensure that standard conduct and procedure following is in the DNA of the organization and it is not induced due to any audit requirement.

Ways in Which Pharmaceutical Audits are Conducted

There are three ways in which pharmaceutical audits are conducted:  

  • On-site audit  
  • Remote audit 
  • Self-audit

On-site audit– It is the audit in which third party auditor visits your organization and reviews documents, procedures, and processes. It will interview your staff, will see facilities and check if your organization meets the regulatory requirements.  

Remote audit– Remote audit is very similar to on-site audit but with an exception. Auditor does not visit the site physically but visits the site virtually and connects with the organization via video conference.

There has been a surge in remote- auditing post and during Covid due to various physical restriction. Like all other industries, audit also went remote, and this practice has become very commonly acceptable now.

Self-audit– Self-audit is the audit conducted by a department personnel to check if the department functions as per the set standards of quality, adheres to various laws, and functions according to SOPs.  

Generally, these personnels are department heads who do self-audit. Self-audits are generally conducted frequently to make sure that all boxes of quality parameters are checked.

How to Prepare for Pharmaceutical Quality Audit?

How to Prepare for Pharmaceutical Quality Audit

Preparation to audits can avert various chaos at eleventh hour. Hence, it is always advisable to be prepared for it. Here is some check list for smooth audit preparation.  

Documentation–  

Review all the past audits. Based on that, prepare a list of documents which consists of (but not limited to)  

  • Batch records 
  • Master formula records 
  • Standard operation protocols 
  • Change controls 
  • Deviation 

These documents must be current and must be validated and arranged.  

At such point of time, an efficient pharmaceutical document management system such as QualityPro comes into use. With the help of such a tool, you can easily arrange documents, create new documents, digitize documents, and make various versions (while keeping old versions).  

Prepare an audit plan-

Prepare an audit plan and prepare a flow of the audit. This plan of action will be provided to audit inspector.  

QualityPro by TecWork helps you to plan, define and document audit objectives, including the scope, purpose, and goals of the audit.  It can also help to schedule different audits to execute in near future such as ISO and FDA as per your convenience.  

Conduct an internal audit-  

Internal audit will do a dry run before final audit. This will highlight any loophole in the process, procedure before the final audit. Remember to deploy an independent team for internal audit to make the audit fruitful.  

Tips to Make Auditing Smooth: 

  1. Make sure that all the key personnels are available at the time of audit.  
  2. Provide a separate room for auditor. 
  3. Be on time.  
  4. Maintain professionalism. 
  5. Take notes of auditing.  
  6. Answer auditor’s all questions honestly.  
  7. Provide only copies of documents and not originals.  
  8. Don’t leave the auditor with your documents and notes.  
  9. Conduct an exit interview with the auditor after the audit.  
  10. Soon after the audit is completed, prepare for your answer for any discrepancy highlighted by the auditor.  

Pharmaceutical Audit Management Software Solution: 

Pharmaceutical companies depending upon old paper and pen-based model struggle and face lot of challenges regularly.  

Recording on paper-based system is a very long and time-consuming process and generally it is error vulnerable. Documentation errors can lead to regulation non-compliance. This can be costly for the company in terms of money, brand image and time.  

With the help of Quality Management Software (QMS) like QualityPro, organization can remove error-prone processes and digitize documentation recording process. It can offer tighter safety protocols, maintain audit trails, streamline audit workflow, and help organization to analyze findings and act proactively.  

It offers an intuitive dashboard to get all audit related information like past audits, open findings, critical findings, CAPAs etc.  

QualityPro for Pharmaceutical Industry Offers Numerous Benefits Like:

  • It simplifies complete audit process 
  • Automates all time-consuming tasks saving time and resources 
  • Ensures compliance regulations 
  • Identifies potential risk and vulnerabilities 
  • Helps maintain integrity throughout the organization 
  • Pinpoint he grey areas in your organization that need improvement

To explore and discuss more on the benefits of QualityPro by TecWork for your pharmaceutical company or to explore how aptly does it fit to your unique requirement, Connect with us now.

The Power of a Document Management System in the Pharmaceutical Industry

Chirag Panjwani on February 21, 2024

document management system for pharmaceutical

“If it’s not written down, then it didn’t happen”.

Considering the context of our blog topic, this proverb fits perfectly. In the pharmaceutical manufacturing, documentation acts as a mirror to show what’s actually happening within the company.

Moreover, every pharma company must follow Good Manufacturing Practices (GMP). Equally important is the adoption of Good Documentation Practices.

Documents play a pivotal role in establishing consistency across operations and minimize the risk of misinterpretations and errors in communication, thereby ensuring improved product quality.

Adding to it is the need of managing hundreds may be thousands of formulas, both active and inactive along with their versions. Not to mention, regulatory bodies while inspecting a pharmaceutical manufacturing organization, precisely examines and validates all the documents and records, ensuring the processes, procedures, and products are adhering to the set industry standards, upholding the quality.

It is not overstating to say that in an industry like pharmaceuticals, where even a slightest error can have life-altering consequences for patients, documents act as the guardian of quality, safety, and compliance.

They act as the foundational stone for establishing quality management system in the pharmaceutical organizations.

However, a pharmaceutical manufacturing organization generates thousands of documents throughout the lifecycle of a product.

To manage such a huge volume of documents there should be a systematic and streamlined approach. And any system other than a document management system would succumb to errors and inefficiencies.

What is a Document Management System?

A document management system is defined as a systematic set of procedures and policies related to creating, capturing, storing, and tracking documents efficiently within an organization.

However, manual management of such a large volume of documents poses inherent risks and inefficiencies. Recognizing this, a crucial need for an automated document management software arises.

It eases the task of document management by providing a centralized, organized, and secured platform, enhancing efficiency of the tasks related to documents.

Features of an Effective Document Management Software-

An effective document management software encompasses a multitude of functionalities, elevating organizational convenience and streamlining operations.

Automating the Process of Document Management-

The software automates the complete document lifecycle right from creating to controlling, managing, organizing, and retrieving when required.

Moreover, it also manages multiple versions of documents separately, ensuring that only the Active version is being accessed by everyone.

Ensuring Timely Updates of Documents-

The software helps users to ensure that all the documents are up to date by providing alerts for expiry or whenever a document is due for revision/updates. It also sends notifications for release or pending approvals of documents.

Providing Easy Access to Crucial Documents-

By organizing all the documents at a centralized location, categorizing them based on file type, data type, and priority level, and allowing to search documents via metatags, a pharmaceutical quality management software facilitates easy and quick access anytime, anywhere.

Ensuring Safety Through Access Control-

By enforcing access controls over the documents via passwords, a pharmaceutical document control software prevents from the risks of data theft or lost documents, ensuring tightened safety.

It also tracks all the activities performed on the documents, maintaining an audit trail of who and when viewed and modified the document.

Allows Effective Collaboration-

A robust pharmaceutical document management software enables such a capability that allows multiple people to collaborate and work on a common document without altering each other’s work.

Benefits of a Document Management Software-

When a pharmaceutical organization implements such an effective and capable document management software, it experiences immense benefits on multiple business fronts-

Benefits of Document Management System

Adherence to Compliance-

With an effective document management, a pharmaceutical organization will be audit-prepared every time with all the necessary regulatory documents, which will eventually lead to fewer compliance issues. This will even speed-up submitting documents for an Investigational New Drug Application.

Increased Operational Efficiency-

Today’s pharmaceutical industry demands an environment of agile decision-making and for this, critical documents accessibility plays a vital role. Enabling quick access to all the documents anywhere, anytime reduces the time usually spent on locating the required files, enhancing overall operational efficiency, and eliminating delays.

Maintains a Single Source of Truth-

By establishing a unified repository, a document management software for pharma industry ensures that all the stakeholders, researchers, and other employees access same information. This eliminates the risk of miscommunication between the departments that may arise when multiple documents are circulated.

Enhanced Security of Business Data-

Through role-based access, complete audit trail, and robust disaster recovery options, a document management software prevents loss or theft of data, ensuring high-end security.

Faster Time to Market-

A document management system (DMS) improves time-to-market by enhancing collaboration, ensuring version control, expediting approval processes, and facilitating quick document retrieval. With a centralized access to all documents of concepts and prototypes, automating workflows, and enhancing compliance management, a DMS accelerates the product development lifecycle, enabling faster delivery to market.

Final Thoughts-

Nowadays, pharmaceutical organizations that still relying on traditional (manual) practices of managing documents are likely to face a plethora of challenges.

So, implementing a document management software is the unavoidable need. However, choosing the right one is equally important for success. To your rescue come QualityPro’s Document Management System. It proves to be the perfect choice.

It is the best quality management software with having robust and effective document management module that not only offers you the aforementioned functionalities, but it also allows easy integration with other quality related modules like Change Management, Standard Operating Procedures (SOP), Risk Management, Audit Management, Training management, Complaint Management, etc.

Document Version Control: Key Methods You Should Know

Chirag Panjwani on December 7, 2023

In the fast-paced world of business today, document management is vital for productivity and compliance. Document version control, also known as versioning, plays a pivotal role in this process. It enables the tracking and management of document changes over time, ensuring accuracy, compliance, and seamless collaboration among team members.

Yet, managing versions manually can be cumbersome and prone to human errors, leading to version chaos. Document Management Software (DMS) makes things easier by putting all documents in one place, controlling versions, managing edits, and keeping track of changes. With DMS software, keeping documents up-to-date and compliant has never been easier.

Result: Smoother and reliable document management with 100% accuracy.

Looking to simplify document version control? Try our “DMS Software” today.

If you’re eager to explore version control, its best practices, and how DMS software simplifies it, then keep reading the blog. Something interesting is waiting for you at the end!

Table of Contents:

What is Document Version Control?

Version control tracks different document versions and changes made over time. Imagine you are working with a team on a project. You are constantly updating and refining a document. This document could be a company policy or a research paper.

Version control tracks every change in a document, from the first draft to the final polished version. It records addition, deletion or modification, creating a sort of timeline or history. This is incredibly valuable, especially in collaborative efforts, because it lets you know who did what and when they did it.

Whether it’s correcting a typo, adding new information, or suggesting improvements, it ensures transparency in the entire document’s evolution, making it simple to review past decisions and understand why certain changes were made.

Version control is similar to a document’s diary. It records the document’s growth and assists in managing it effectively. Multiple individuals find this particularly useful when they are involved in its development.

Why Do Businesses Need Document Management Version Control?

To successfully implement document version control, you should have the following elements in place:

  • Clear Versioning System: You’ll need a standardized way to label different versions of your documents. For instance, you can use numbers (like 1.0, 1.1, 2.0), letters (A, B, C), or a combination of both.
  • Audit Trail: A system that keeps track of and records all changes made to a document. This includes the person who made the changes, the time when they made them, and the specific changes that were made.
  • Access Control: Permissions and controls to limit who can edit a document, ensuring only authorized individuals can make modifications.
  • Storage and Retrieval: A secure place or document management system to safely store, organize, and easily find documents.
  • Collaboration Tools: Tools and features that make it easy for teams to work together on documents while still maintaining version control. For example, a check-in/check-out system can help prevent conflicts when multiple people are editing the same document.

Key Facts & Figures on Document Version Control Systems

To illustrate the importance of document version control, consider these statistics:

  1. According to a McKinsey report, employees spend 1.8 hours every day searching and gathering information. On average, that’s 9.3 hours per week!
  2. In regulated industries like healthcare and pharmaceuticals, document version control is critical for compliance. Failure to comply with regulations can result in hefty fines.

For example, in 2020, the U.S. Department of Health and Human Services issued over $36 million in fines related to HIPAA violations.

Best Practices for Effective Document Management Version Control

Proper version control helps organizations maintain consistency, track changes, and mitigate errors. Here are some key reasons why implementing best practices for document version control is crucial:

Appoint an Administrator: Hire an EDMS administrator to oversee document management, compliance, and system maintenance.

Maintain Document History: Keep a clear version history to track changes and easily revert to previous versions, when needed.

Secure Documents: Use “check-out” features to protect documents from unauthorized edits and unnecessary revisions.

Member Controls: Implement precise access controls to restrict editing based on team roles.

Workflow Automation: Set up standardized workflows for tasks like watermarking, PDF generation, and electronic signatures.

Device Accessibility: Choose an accessible eDMS that’s interoperable from on computers, tablets, as well as smartphones.

Enhance Security: Implement encryption and backup plans to ensure document security and data integrity.

Integration: Connect your version control system with existing IT systems for better document management.

Common Challenges in Managing Document Versions for Manufacturers

The challenges that you might face while managing document versions manually are as follows:

Document version control methods

Production Blueprints:

In manufacturing, detailed blueprints and engineering drawings are essential. When manual version control is in place, it’s easy for errors to occur. For instance, using an outdated blueprint in the production process might lead to a costly error in the final product.

Example:

Imagine a car manufacturer working on a new model. If the team doesn’t use automated version control, they might use an old blueprint by mistake. This can cause design problems and delays in production.

Quality Standards: 

If multiple versions of a quality control manual exist, it can be challenging to ensure that workers are following the correct procedures, potentially leading to subpar products or safety issues.

Example:

Consider a food processing plant. Having multiple versions of the quality control guidelines can lead to workers being unaware of the latest safety procedures. This lack of knowledge increases the risk of contamination or product recalls.

Regulatory Compliance: 

Manufacturing businesses often operate under strict regulatory frameworks, such as ISO certifications or environmental standards. Failing to maintain precise version control can result in non-compliance and legal consequences.

Example:

In the aerospace industry, keeping track of the latest versions of documents related to safety and environmental regulations is crucial. Outdated versions could result in fines or even the suspension of operations.

Therefore, manufacturing companies often turn to automated Document Management Software to ensure precision, compliance, and efficiency in their operations.

How a Document Management System Supports Version Control?

A Document Management System (DMS) is a digital tool that helps store, organize, and track documents. It ensures easy access, security, and version control. Document version control is crucial for managing information effectively within organizations.

It ensures that everyone works with the most current and accurate documents. Here’s how a Document Management System (DMS) enhances this process:

  • Accuracy: A DMS software maintains a single, updated version of each document, eliminating confusion caused by multiple versions circulating within a team.
  • Compliance: It tracks changes and provides an audit trail, simplifying compliance with industry regulations by ensuring documents adhere to necessary standards.
  • Efficiency: DMS software enables real-time collaborative work, allowing multiple users to edit documents simultaneously. It also preserves version history for easy tracking of changes.
  • Confidence: Employees can trust the documents they access, knowing they are the latest, approved versions. This confidence boosts productivity and decision-making.

Document Management Software automates these processes, ensuring documents are secure, easily accessible, and always up to date. One such automated document management system is QualityPro.

How QualityPro Improves Document Management and Version Control?

QualityPro is a Digital Quality Management System that significantly enhances version control of documents and processes within an organization. Here’s how QualityPro achieves this:

Enhances Version Control
  • Centralized Document Repository: QualityPro provides a centralized repository for all documents, including policies, procedures, and work instructions. This ensures that all users access documents from a single, secure location, minimizing the risk of multiple versions floating around.
  • Automated Versioning: The system automates version numbering or naming, eliminating manual errors in labeling documents. It assigns version numbers or names consistently, making it easy to differentiate between document versions.
  • Access Control: QualityPro allows administrators to define access permissions for users and groups. This means that only authorized employees can edit documents, ensuring version integrity and document security.
  • Version History Tracking: The system maintains a detailed version history for each document. It keeps a record of who made changes, when they made them, and the nature of the modifications. Users can easily review the document’s evolution and track all changes over time.
  • Collaboration Tools: QualityPro facilitates collaboration among team members. Multiple users can work on the same document simultaneously, and the system seamlessly merges changes. This ensures that all contributions are incorporated into the final document.
  • Revision Control: The system enforces strict revision control, allowing organizations to manage document changes efficiently. Users can submit proposed changes for review and approval, ensuring that only authorized modifications are accepted.
  • Workflow Automation: QualityPro streamlines document approval processes through workflow automation. This ensures that documents move through the approval chain smoothly and that the right individuals review and authorize changes.
  • Notification and Alerts: QualityPro can send notifications and alerts to users when document changes occur or when approvals are required. This keeps users informed and ensures timely responses to document modifications.
  • Archiving and Backup: The system includes archiving and backup features, allowing organizations to retain historical document data. This ensures that previous versions are accessible if needed for reference or auditing purposes.

Concluding Thoughts,

So, are you ready to elevate your document version control? Take the next step toward enhanced accuracy, compliance, and efficiency with us.

Feel free to “write to us” to know more about it as well as our other products.

Types of Audits in Quality Management

Chirag Panjwani on November 22, 2023

Quality audits assesses how well a product, design, process, or system meets specified standards or procedures. The auditors can perform quality audits both within the organization and externally, concentrating on particular processes, products, or systems.

Quality Audits have two Major Components:

  • The quality system audit, which evaluates the overall system’s effectiveness, and
  • The product or service quality audit, which assesses the products or the services offered

If you are a manufacturing company, seeking to improve your audit process and speed, then this blog is a must-read for you.

Looking for smarter audits? Explore our “Audit Management Feature” now.

Table of Content:

Overview:

Quality Audit is like having a check-up for the quality of business aspects/entities. For example, Quality Audit in pharma industry is like a check-up for a pharmaceutical company’s quality system, making sure everything is working as per the norms defined by the industry and regulatory bodies.

This check-up is done by an audit team or an auditor. These people can be from inside the company or from third party. They examine and verify procedures, records, and activities to make sure they meet the required standards.

A quality audit is important for ensuring that a company follows the ISO 9001 quality system standard. It is also important to ensure that the company performs the correct operations to maintain good quality practices.

Definition of Quality Audit

A quality audit is a systematic, independent examination and evaluation of processes, products, or systems within an organization to determine their compliance with established quality standards, regulations, and best practices.

In simple words, quality audits assess if systems, processes, machines, and manpower are working well, and if in case of deviations, root causes are identified and fixed promptly.

Why Quality Audits are Important?

Regular quality audits are essential for companies to assess performance and formally document outcomes. Organizations regularly performing internal audits gain substantial benefits, pivotal for optimizing growth. These audits evaluate company efficacy and provide insights for effective strategy alignment.

The insights gained from quality audits can lead to more revenue and numerous benefits. With proper quality audits conducted, companies can:

  • Improve the quality of the system as well as the quality of the product
  • Assess the cost-effectiveness of quality systems
  • Measure the effectiveness of quality tactics 
  • Increase productivity by making product output more uniform, reducing mistakes, and cutting wastage of resources and manpower
  • Give employees the chance to report inadequacies in the interpretation of basic quality requirements.

In addition, quality audits identify the root causes too, so organizations can quickly take corrective action. Process, product, and system audits should be front and center of any quality management strategy.

Types of Quality Audits

Types of quality audits

The following is a list of commonly performed quality audit types:

Internal Quality System Audit:

Internal Quality System Audit refers to an evaluation conducted within an organization to evaluate and ensure the effectiveness, compliance, and continuous improvement of its internal quality management processes and procedures.

This audit is performed by internal auditors or quality assurance teams to identify areas for enhancement, confirm adherence to established quality standards, and promote overall operational excellence.

The team reviews work instructions to ensure they follow standard procedures and meet quality targets.

Example: The auditors in the company check documents, processes, and employee access to ensure everything is functioning properly. 

Searching for a faster way to manage audits? “Request a Demo” now.

Supplier Audits:

Supplier audits includes a process of evaluation and collaboration aimed at ensuring both quality and accountability. By comprehensively analyzing multiple factors, companies secure the reliability of their suppliers while holding them responsible for any performance challenges.

The real-time transparency offered by these audits allows businesses and suppliers to jointly monitor purchase order activities and actively address any instances of non-conformities and errors.

For instance, the purchasing team can meticulously review suppliers based on key criteria such as lead time, product quality, cost–effectiveness, and certifications.

Production Team Audit:

Production Audit involves checking the work done by the production team. Companies often audit them for Operator Acceptance or Certified Operator programs, or when they need to requalify their skills.

Auditors review changes to their processes, training records, and past work to ensure everything is up to the required standards.

For example: Auditors check if the team followed procedures, and met quality criteria during pre-qualification.

Safety Audit:

During a Safety Audit, the team checks the plans and procedures in place that keep company employees safe. They review how an equipment is used and cross-check the organization’s safety steps.

The company must implement structured safety policies to prevent accidents and injuries, creating a safer and healthier environment for employees.

For example, a safety auditor can examine how employees use safety gear while operating machinery. Or, how hazardous materials are stored in a company’s warehouse.

Facilities Audit:

Facilities Audit checks the quality of a company’s assets, like buildings and equipment. The auditors should monitor systems like water tankers, ACs, HVAC (heating, ventilation, and air conditioning), manufacturing equipment, technology, etc.

This type of audit focuses on ways to improve safety and quality outcomes.

Example: During a facilities audit, the team inspects the fire extinguishing system to ensure it is approachable and works efficiently, creating a safer workplace for employees.

Environmental Audit:

Environmental audit helps companies make their workplaces greener and less polluted/toxic. It identifies potential risks and creates a plan to meet safety standards like OSHA, cGMP, etc. The audit team checks to see if employees follow these standards and use proper disposal techniques.

For example, the team inspects if hazardous waste are disposed of properly in the prescribed way and proper documents are maintained for it.

Risk Assessment Audit:

Risk Assessment Audit helps companies identify workplace risks. They categorize each risk and put measures in place to prevent accidents, quality issues, machine failures, natural disasters etc.

For example, during the audit, Auditors may identify that the slippery floors in the manufacturing area pose a risk of falls. To prevent accidents, they install non-slip mats and provide safety training to employees. This way, they reduce the chances of workplace injuries and avoid potential financial losses.

Design Control Audit:

Design Control Audit ensures that manufacturers follow a proper, compliant, and systematic method to produce safe and high-quality products that meet user needs.

The audit team solely reviews the design plan, inputs, and outputs to ensure they meet specific criteria and analyze potential risks before they occur.

For example, in the medical device industry, the audit team can check if the design of a new surgical instrument meets the required safety standards. And, if it effectively fulfills the needs of surgeons during procedures. If not, they can take appropriate actions to address and rectify the issues.

Regulatory Audit:

Regulatory Audit checks if a company follows specific rules and standards set by regulatory agencies. They review quality practices and gather crucial data to find grey areas where the company is not following the rules. 

For example, the auditors can verify if the aircraft manufacturer complies with FAA (Federal Aviation Administration) regulations to ensure the safety and quality of their aircraft.

Method Validation Audit:

Method Validation Audit is done by regulatory authorities like the FDA to check if the testing methods used in manufacturing are standardized, consistent, and well-documented. It ensures that products made for human use are reliable and accurate.

For example, in pharmaceutical manufacturing, a method validation audit can verify the testing procedures used to check the potency and purity of medicines, making sure it is effective in curing the disease for which it is made.

However, managing all these types of audits together can be a cumbersome task. But, with comprehensive audit management software in place, audits can become as simple as ABC.

It effectively manages all types of quality audits while streamlining the entire audit process. From planning to reporting, the software ensures that the audits conducted are effective, consistent, and accurate.

QualityPro: To Manage all your Audit-related Activities

QualityPro is the next-gen QMS software with a feature-rich audit management solution. It can automate audit tasks, provide a central repository for documentation, enhance communication, track progress, and provide indepth insights. 

This audit management software makes audits easier by ensuring they are done consistently, efficiently, and effectively. It automates audit scheduling, generates checklists, stores evidence, creates reports, and tracks corrective actions.

Using this audit management solution, audits occur effortlessly, cover all important areas, keep the proofs safe, share results with management and stakeholders, and implement fixes on time. It simplifies  

Key Features of QualityPro: an Audit Management Software can

  • Manage and submit quality management system audit checklist
  • Define different types of audits and specify whether the audit requires approval or not
  • Define different audit categories, like Departmental Audit, Documents Audit, Financial Audit, Organizational Audit, etc.
  • Define different audit classes like Internal, External, Remote, etc.
  • Manage and store all the points that make up an audit checklist
  • Specify the different requirements that make up an audit checklist
  • Perform follow up audit to ensure that the corrective actions put in place were effective
  • Audit module is connected with CAPA, any NC encountered during Audit can be escalated for root cause analysis and CAPA, and this NC, upon resolution can again be sent for follow up audit ensuring 100% rectification.

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