QualityMaster

Types of Audits in Quality Management

Anmol Pandit 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.

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. 

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.

QualityMaster 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 QualityMaster: 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.

To explore more on how it can benefit your organization, feel free to connect  our sales team or visit our website!!

Simple Guide to SOP Management in Pharma Industry

Ravi Jotwani 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.

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?

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.

QualityMaster, 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 QualityMaster.

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

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

  1. 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.
  2. 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.
  3. 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.
  4. Guideline Attachment: QualityMaster 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. QualityMaster 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, QualityMaster 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.

QualityMaster’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.