Solutions  >  Quality Management  >  Quality Control and Quality Assurance

Quality Control and Quality Assurance

Quality control and quality assurance are the two building blocks of quality management. While QC helps identify and rectify defects, QA is used to prevent defects.

Quality Control and Quality Assurance
Quality Control and Quality Assurance
quality control assurance video

Quality Management is a regulatory requirement in most industries. But even if not mandated, it is a critical aspect of survival and growth as it directly impacts operational efficiency, resource optimization, and customer satisfaction.

Quality management rests on two pillars: Quality Control and Quality Assurance. Quality Control and Quality Assurance are interrelated but also distinct in activities and objectives. Quality control is a subset of quality assurance, which covers almost all aspects of the quality system. Some aspects of the quality system may be outside the purview of quality control and assurance activities and responsibilities, but will still require Quality Control and Quality Assurance to be effective.

ISO 9001 defines Quality Assurance as activities that ensure meeting the requirements of quality management objectives by focusing on the processes. It provides two-fold confidence about quality—on the one hand, it reassures the management of ensuring quality; and on the other hand, it also provides confidence to customers, partners, regulators, government agencies, and third parties of quality. It assures the quality of the product or service provided by the company through planned and systematic implementation of activities aimed to support the quality system.

Quality Control aims to fulfill the quality requirements specified by the quality management policy. Inspection and monitoring of operational techniques and activities form the core focus of quality control.

Request an Online Demo

Related Assets

Difference Between Quality Control and Assurance

There are several difference between quality control and assurance.

quality assurance
Quality Assurance

Quality assurance ensures the correct implementation of manufacturing techniques, processes, methods, and approaches, aligned with the quality management policies and goals, to ensure the quality and performance of the product or service. It helps proactively uncover risks and errors in the process to prevent issues in the final outcomes. This is done before quality control and aims to prevent defects and deviations. It integrates proactive and preventive approaches to quality and ensures conformance and compliance.

quality control
Quality Control

Quality Control is a process that ensures that the final product conforms to the specifications, meets the defined quality standards, is compliant with relevant regulations, and performs as expected. The focus is on the end product rather than the processes to achieve the final outcome. It is reactive in nature, detecting errors before they occur but before reaching the customer.

Major Differences Between Quality Control and Assurance

There are several differences between quality control and quality assurance. The purpose of quality assurance (QA) is to ensure that a project or product development is progressing as expected, aligned with the policies and standard operating procedures, to deliver an outcome compliant with standards and objectives.

Quality control (QC) focuses on monitoring the final output to detect errors and ensure the product is of high quality, delivering on its promise.

Quality assurance provides the guidelines, policies, and procedures to manufacture a high-quality product without defects or deviations. In quality control, the final product is reviewed to confirm that the manufactured product or service meets the standards and performs as expected.

Quality assurance runs parallel to the manufacturing process, from planning to product maintenance, while quality control is at the end, during the inspection phase.

QA requires the involvement of every function in ensuring the processes meet the quality standards. On the other hand, QC is more specialized as it requires inspection and testing of the product.

quality assurance and quality control
cell and gene therapy

Robust Quality Control: How Intelligent Automation of Nonconformance, Equipment and Inspection Management Processes will Save Time and Costs

What is Quality Control Management?

Businesses need to ensure the quality of their products and services. This must happen in a planned and focused way, with the involvement of all employees across functions. Enabling this is Quality Control Management, which delineates the quality standards the organization must follow and sets expectations for the teams to meet.

Some of the key pillars of quality control management include:

  • The establishment of a set of business procedures that are aligned to the organization’s strategic direction
  • Ensuring customer satisfaction
  • Continually improving the operations

This it ensures through:

  • Quality planning
  • Quality improvement
  • Quality control
  • Quality assurance

Each of these has a distinct purpose and criticality for ensuring the overall quality management of the organization.

  • Through Quality Planning, the quality team with the business leaders defines the quality standards and the strategy for achieving them.
  • The quality plan is constantly revised and fine-tuned based on feedback and new requirements for continuous implementation to improve outcomes.
  • Quality Control ensures that the process standards are maintained to ensure the integrity of the outcomes.
  • Quality Assurance ensures the adherence to confirmed specifications and standards by reviewing systems and processes.

Features of Quality Control Management Software

Quality management includes a variety of steps and processes to ensure adherence to quality and the performance and quality of the final product or service. Automating the workflow can improve compliance to SOPs and regulations relevant to the industry.

A good quality control management software must include features such as

Quality Control Management Software features
  • Audit management: Internal and external audits are performed to ensure documents, processes, and sites adhere to the systems and processes specified in the quality policy and procedure.
  • Change control: Ensures changes are carried out effectively, after evaluating the potential risks and with proper training and alignment to the new processes.
  • Complaint management: This is a crucial aspect of quality management as it provides customer feedback and input on what works and needs improvement. Complaints also need to be responded to quickly and correctly for customer satisfaction.
  • Risk management: Regulatory bodies need businesses to take a risk-based approach to product development. This improves efficiency, quality, and performance while optimizing resource utilization.
  • Document control: Document management is another critical aspect for regulated industries, as appropriate documents must be easily retrieved if required by the regulatory bodies. A centralized document management system also improves document workflow management while providing suitable access to all stakeholders with appropriate permissions and version control.
  • Supplier management: Quality of input affects the quality of output. Therefore, identifying and onboarding suppliers with the right processes and quality focus is critical for businesses. A good quality control management system enables this by automating supplier qualification workflows, managing scorecards, tracking supplier issues, maintaining applied supplier lists, and managing SCARs, among others.
  • AI-enabled analytics: Analytics have become critical to identifying risks, detecting deviations, and proactively managing quality by accessing data from multiple sources and presenting them in easily readable formats.
  • Training management: Employee training is essential to quality control management as they should continuously keep pace with changing quality and process needs and align with the SOPs. Identifying gaps and providing appropriate training is enabled by the quality control system.
  • CAPA: When an issue occurs, it is not enough to contain. It is essential to identify the root cause and implement corrective and preventive actions to prevent recurrence of the event. Once the capa has been implemented, it must be monitored to assess its effectiveness or course-correcting to derive the desired results.
  • Nonconformance: Timely identification of deviations from specifications will reduce wastage, scrapping, and recalls. Therefore, nonconformance management is an essential component of quality control.
  • Design controls: Product lifecycle management requires design controls to ensure the product meets specifications and delivers on its promise.
  • Security: Providing permission-based controls is essential to protect data and ensure only authorized personnel can access the data.
  • Mobility: In today’s globalized world, it is important for mobile-based access to data for remote workers to be able to access relevant information anytime, from anywhere.
cell and gene webinar

Making the Digital Quality Journey in Cell and Gene Therapy: From Bench to Bedside to Benefit

cell and gene webinar
Watch Webinar

Benefits of Quality Control System

Implementing a quality management system aligned with standards such as ISO 9001 benefits businesses in several ways. These include:

  • Improved efficiency and productivity, providing competitive advantage

  • Providing customers with consistent and good quality products and services, enabling business expansion and growth

  • Lower cost of production due to eliminating wastage and reducing errors

  • Improved resource utilization, further effecting savings and increasing efficiency and innovation

  • Improved risk management

  • Better engaged employees

  • Enhanced collaboration and communication

  • Better performance of products and services

  • Embedding a culture of quality in the organization

A great QMS package

CQ has proven to be intuitive, easy to use and customization is as easy as speaking to the CQ team. The validation scripts are straightforward and easy to edit to meet our organizations particular needs. The system feels familiar while delivering the QMS system tools that we need and the CQ team is responsive to any questions that arise.

Dorothy Wilson,
Quality Assurance & Document and Records Specialist

origen testimonial
origen testimonial

CQ's Quality Control System Software

ComplianceQuest’s Quality Control System Software incorporates several features aimed at compliance to leading standards and regulations. Quality control system software provides features such as:

  • Inspection of raw materials, premises, and products to ensure quality
  • Auditing to identify systemic issues and correct them for continuous improvement
  • Change management
  • Risk management
  • Document management
  • Training management
  • Equipment maintenance for scheduled maintenance and planned downtimes to reduce errors and minimize disruptions
  • Supplier management
  • Complaints handling that helps loop in feedback to improve product quality
  • Design controls to validate and verify design changes, ensure product quality right from the word go, and improve visibility and transparency of the product development lifecycle
  • CAPA to conduct root causes in case of errors and deviations and implement corrective and preventive actions
  • Nonconformance to minimize deviations and ensure only quality products are released in the market
  • Management Review to analyze data and make informed decisions for continuous improvement of quality management system
  • Reports and dashboards to generate and share insights for identifying gaps and areas of opportunities

Ensure the quality of products and services meets the defined standards with our ComplianceQuest Quality Control Management Software

Request an Online Demo



Related Checklists

Quality-centric Companies Rely on CQ QMS

  • affinivax mono
  • verily mono
  • 3m logo mono
  • tupperware mono
  • continental logo mono
  • vyaire mono
  • lifescan mono
  • lundbeck mono
  • cdc logo mono
  • qlik mono
  • csa group mono
  • impossible mono
  • fluence mono

Frequently Asked Questions

  • There are several differences between Quality Control and Quality Assurance. QA is more process-oriented while QC is primarily product-focused. The goal of both Quality Control and Quality Assurance, though, is ensuring a safe and effective product. QA is more proactive, identifying risks by monitoring and improving the manufacturing process continuously. QC is more reactive as it involves inspecting and testing the product after manufacturing to ensure conformance and compliance.

Astronut

Related Insights

6 Steps to Make Inspections Effective for Continuous Quality Improvement
Blog | July 17th, 2023

6 Steps to Make Inspections Effective for Continuous Quality Improvement

Businesses encounter quality-related risks across various stages of the production process. This could be due to factors such as deviations…

View All Resources

Connect with a CQ Expert

Learn about all features of our Product, Quality, Safety, and Supplier suites. Please fill the form below to access our comprehensive demo video.

contact-img

Please confirm your details

In Need of Smarter Ways Forward? Get in Touch.

Get a Demo Today
spinner
Request Demo

Comments