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Why does QMS Software Matter in Automotive Manufacturing?

Chirag Panjwani on November 16, 2022

QMS Software for Automotive Manufacturing Industry

Imagine  the airbags don’t function properly during an emergency, or the car doesn’t stop even after the brakes were applied, or the scooter has skids on the roads? Scary, isn’t it?

These can only lead to misfortunes like road accidents and, have the potential to cause major injuries or even deaths.

You don’t want this to be the fate of your customers and also of your business Automotive Industry carriers on its shoulder the responsibility of the lives of their customers and thus should deliver best quality vehicles. One small design error might result in major blunders, which no one can afford, neither the customer, nor the manufacturer.  So, Quality should be the prime focus for all automotive businesses.

Introduction

Be it a car, traveling bus, goods carriers, trucks or any other vehicle, the transportation medium has now evolved into a sustainable system that ensures smooth journeys, entertains passengers, connects with traffic services, and provides SOS help in case of emergency.  

That said, this evolution has made quality, more important than ever before, manufacturers perform multiple tests on their before sending it to the market.

The makers must ensure that their products are as per the standards,  follow govt & road norms and are fit to use. And, in order to achieve this, automotive manufacturers must deploy a powerful automotive quality system in their businesses.

QMS systems for automotive industry can streamline quality processes, and track and resolve product issues before they are delivered to the market. This solution also helps in meeting compliance, adapting to industries’ best practices, and focusing on gaining operational excellence.

Gartner defines quality management system software as “the business information management system that manages quality policies and standard operating procedures (SOPs). This includes customer requirements, quality documents, ISO requirements, manufacturing capabilities, robust design, auditing procedures and protocols, nonconformance/risk management activities, testing criteria, industry-specific regulations and much more.”

Ref: https://www.gartner.com/reviews/market/quality-management-system-software

Quality Management systems for Automotive Manufacturers

Quality is characterized in the automotive industry by high production rates and low failure tolerance. Even if quality has different limitations, the influence on people’s lives justifies the automotive industry’s constant emphasis on quality.

Based on customer demands and legal constraints, quality management has grown into a key strategy for many industries, including the automotive sector. Before a company makes any product available for consumer use, quality checks, audits, and ISO standard compliance should be thoroughly checked.

It makes sure that you are using the proper procedures and workflows to achieve customer satisfaction. Automotive quality management solutions can help you to prevent quality issues from occurring and enable continual improvement of the business.

How Quality Management Systems matter in automotive Suppliers and Manufacturers

From safety inspections to compliance audits, the automotive sector needs to achieve certification in specialized ISO standards as well as quality standards. A well-managed QMS is therefore something that can’t be skipped.

Quality in the product, quality in manufacturing, and quality in ownership—are the foundation of automotive quality.

Quality in product means the functional benefits of the particular produced item, while quality in production means consistent production standards and quality in ownership relates to customer satisfaction. And so, automotive manufacturers must put a quality management system in place to ensure regulatory compliance and operational excellence. Companies can plan, design, implement, and control business processes throughout the supply chain by automating their quality procedures with a QMS.

Here are some important aspects that can justify the importance of automotive quality management software:

  • To efficiently capture, manage and track non-conformance issues and perform root cause analysis to never let that issue happen again.
  • To identify product quality issues, take containment actions, mitigate recurrence & verify the effectiveness of root cause elimination.
  • To investigate, track and resolve quality-related customer complaints right from identification to resolution
  • To automate the training process & store the important curriculums and schedules centrally.
  • To establish a proper document workflow, automate changes (if done), and secure them with authenticated access.
  • To store, create, track, retrieve, secure & manage organizational documents.
  • To stay compliant with all the crucial norms and manage potential issues using automated alerts.
  • To assess risks and analyze their impact so that measures could be taken to mitigate them.
  • To automate & streamline the process of planning, scheduling & conducting audits.

How to Ensure Proper Quality Controls in Automotive Industry?

Quality needs to be firmly rooted in automotive manufacturing and good QMS software must ensure that quality is maintained at all levels.  With a proper automotive QMS in place, the consistency of the vehicle parts and automobiles produced is ensured. All parts manufactured are also guaranteed to be par with the standards. This leads to a more efficient manufacturing line, which is more resource effective.

Ensuring proper quality controls in the automotive industry would require you to-

  • Streamline supplier quality-related process

Quality control in the automotive industry starts with the kind of raw material procured from the supplier. To make sure that you are doing business with the right vendors, their certifications and other details must be checked and stored in a systematic document format. And for this, a quality management solution can help by suggesting buying only from the certified vendors. It even alerts when a vendor certification is nearing expiry.. It also improves collaboration and communication with the suppliers, strengthening business relationships.

By analyzing and optimizing supplier-related procedures, the automotive industry may achieve operational excellence and respond to market changes much more swiftly.

  • Establish an effective NC/CAPA Management System

Nonconformance are common in manufacturing, but they aren’t acceptable. So, you must have a well-defined CAPA management process to manage defects and deviations that could impact product quality. An effective NC/CAPA management solution can help automotive companies to identify the root cause of the problem efficiently and eliminate them, so they do not reoccur. Such system has a reliable for tracking and reporting non-conformances. QMS system with NC/CAPA helps in determining all non-conformances with the necessary information.

QMS software for automotive also gives you more visibility through the product failure trends and develop an action plan accordingly. By establishing an effective CAPA management system, it can help you take a holistic approach to prevent and correct systemic issues.

  • Simplify Parts and Component Inspections

Because of the wide variety of products, production methods, and testing cases, maintaining consistency in the automotive industry is challenging. However, robust Inspection Management software can be helpful in streamlining the incoming, in-process, and outgoing inspection processes. It also ensures the quality of incoming materials by standardizing sampling plans across different components and products. You must ensure that the QMS software they use has an intuitive and customizable interface in order to have simple and efficient inspections done.

Companies in the automotive industry that standardize inspection procedures are more likely to avoid poor outcomes and needless expenditures associated with a product recall.

  • Handle Complaints Effectively

An efficient process for managing complaints must be put in place for automotive companies if they intend to keep their clientele happy and loyal.  Automotive QMS manages and performs the full Complaint lifecycle, which includes identifying the issue, conducting a root cause investigation, instantly answering consumer inquiries, and initiating both internal and external corrective and preventative actions.

Automotive companies that have a standardized complaints module in their QMS systems are likely to build lasting business relationships with their customers, suppliers, and stakeholders.

  • Perform periodic audits

Companies need Audit Management to carry out and manage external and internal audits and maintain quality standards in the automobile industry. To prepare firms for audits, it is crucial to select a system that offers IATF 16949 compliance. You should have more freedom to carefully prepare for yearly, biennial, quarterly, and ad hoc audits with the QMS software. And so, make sure the quality management software you select includes customizable workflows to easily manage various audit types.

  • Provide Best-Practices Training to Your Workforce

Training is an essential part of staying on top of all certifications that the organization requires. An effective training management system identifies training needs within different departments and monitors the results of all training, including documents, read and signed-off assessments, and instructor-led training. An organization can also release certificates based on employee performance. Automotive companies should emphasize employee competency through effective training programs through a Quality Management System to ensure that they follow best practices to achieve the organization’s quality objectives.

  • Manage Controlled Documents and their Changes

Automotive companies can put their trust in Document Management System of a QMS to manage all their business-critical documents from creation to approval, publishing to archiving and removing them permanently. With the QMS solution, you can schedule approvals, archival, and document management well in advance. Users and organizations can work collectively to review documents and notify through alerts when the changes are done.

QualityMaster for Automotive Industries: One-Stop Solution to manage all your commute vehicles

Manufacturers can maintain production efficiency and profitability while achieving the highest levels of quality with QualityMaster. It is a cutting-edge quality management software for the automotive industry. hosting a variety of features like Change Management, Complaint Management, NC, CAPA, Training Management, Compliance Management, Risk Management, and more. –

Modules of Quality Management System

Manufacturers can keep up with the most recent production definitions in accordance with ISO, IATF, and governmental regulations with the help of QualityMaster. Moreover, the much-needed responsiveness to customer queries and complaints is just a click apart.  The user gets a personalized cockpit to optimize operations for ongoing improvements. It even makes it easier for manufacturers to issue SOPs, carry out safety inspections, and raise alarms right away in the event of deviations. It makes sure that industry best practices are followed in order to assist vehicle manufacturers in maintaining compliance and obtaining the necessary level of consistency and product quality.

Final Thoughts

Thinking about elevating your quality processes and streamlining all the activities, then visit us.

Four Key Ways QMS Software Supports Change Management

Chirag Panjwani on September 27, 2022

Change management in QMS system
  • Overview
  • What Is Change Management?
  • Process of Change Management
  • How QMS supports Change Management
  • Conclusion

Overview

Heightened global competition has motivated manufacturing companies to constantly innovate their product offerings. To keep pace with this accelerated pace of change, companies need to develop a dynamic work culture and environment. Change does not come naturally to people or organizations and without proper management, a change can cost precious time and money. It is also vital to measure the scale, magnitude, duration and strategic importance of the change.

Organizations would do well to address and balance the multiple aspects of change like people, process, technology etc. Creating a change management plan can help with a smoother transition from the old to the new. While proactively combating resistance to change, companies need to set clear goals for the changes and monitor the results vigorously. By creating effective strategies to implement change, manufacturing organizations can ease out the process for their people.

What is Change Management?

Change management is the process of planning, implementing and validating changes in the organization. It refers to the organization’s ability to handle modifications like implementing new technology, adjusting existing processes and shifting organizational hierarchy. Change managers need to set key performance indicators (KPIs) and relevant metrics to measure the effects of the change. In the present scenario of rapid product changes, the co-ordination of design centers, suppliers, testing labs, manufacturing facilities, offshore plants and the marketing department becomes very critical in change management.

Change can be a consequence of innovation, customer complaints, material returns, non-conformances and similar occurrences. Upon implementing a QMS (Quality Management System) in the organization, managers can standardize their response to every new development with automation. It can even shorten the change process cycle time and reduce the impact of change on everyday operations. We will elaborate about the benefits of QMS for change management further in the blog, but let us first discuss the process of change management.

Process of Change Management

Businesses must constantly evolve and adapt to meet a variety of challenges like changes in technology, rise of new competitors, a shift in laws/regulations or any underlying economic trends. Change processes have a set of starting conditions and a functional endpoint. Change initiatives may be different from each other, but they typically follow a similar process. To effectively manage change, managers must thoroughly understand the steps involved. The key steps in the change management process are listed below:

Process of change management
  • Prepare – The organization needs to be prepared for change, both logistically and culturally. All employees should recognize and understand the purpose of change.
  • Plan – The definitions of KPIs and strategic goals should be pre-defined. The scope of the project and the hierarchy of reporting must be laid out beforehand.
  • Implement – The steps laid out by the management must be diligently followed. Employees need to anticipate roadblocks and prevent, remove, or mitigate them once identified.
  • Embed – The changes inculcated by the process should become part of the company culture. Change managers need to ensure that the process doesn’t revert back to the old ways.
  • Review – conducting analysis and review to make sure that the change was successfully implemented. It can offer valuable insights that can be leveraged in future change efforts.
How QMS system supports change management

How QMS Supports Change Management

Paper-based quality processes can hinder innovation-centric changes and even cause non-compliance in a regulated industry. By implementing a QMS, the change is managed in a workflow-based system and quality is benchmarked at every step. The “Make it once, change if often” philosophy of the present product developers can benefit from the dynamic work environment created with the help of a QMS. Let’s discuss the four key ways QMS software supports change management:

  • Change Process Automation – Automation of the change management process results in increased control over the variables. A QMS provides the right tools for the organization to exercise control over the tasks, processes and documents of change. Everything including routing, follow-up and approval can automated through a QMS.  Managers can effectively define process ownership and user control for increased accountability. Automatic escalation can speed up departmental collaboration and new approvals can automatically supersede any old versions.
  • Transparent Change History – A time-stamped and secure audit trail enables the stakeholders/auditors/regulators to view the entire edit history of documents in a chronological order. Complete record of people who request, approve and validate the changes is also saved in the system to allow for complete transparency. QMS can also present key metrics relating to open change tasks on a unified dashboard and generate reports in an efficient manner to identify bottlenecks and other issues.
  • Closed-loop Change Management – Vigilance is not enough for compliance. Organizations need a QMS to follow a proactive approach by connecting all quality processes. CAPA issues and deviations will seamlessly trigger change management and training through the QMS system. If a CAPA issue requires new training, the QMS will facilitate task completion with automatic notification and follow up. The system unites different processes and individual users into a holistic compliance effort so that every issue is identified and resolved.
  • Shorter Change Cycle Time – Efficient change management and change control leads to timely regulatory submissions and faster time to market. Once a change control request gets approved, a QMS automatically generates and routes all the related documents (Ex. SOP, change order) to the concerned departments. Gone are the days, when this process was done via long trails of e-mail or through in-person meetings. Every step of implementation and post-implementation assessment are automated with QMS to close the loop quickly and effectively.

QMS can help companies achieve change management and change control according to cGMP regulations and ensure product safety and quality. While every regulated company wants to comply with requirements, they need to leverage the right QMS software to attain and maintain compliance despite the constant change in their operations. QualityMaster is a next-gen QMS software that supports change management along with all the other quality management requirements of a manufacturing company. If you wish to request a demo, please click here.

What is Quality Management System in Manufacturing Industry?

Chirag Panjwani on April 10, 2022

Manufacturing businesses encounter various challenges, stemming from internal and external factors, often impeding operational control. A robust Quality Management System (QMS) proves instrumental in tackling these challenges, providing enhanced control over every manufacturing process. This blog elucidates how a QMS serves as a solution.

QMS for manufacturing industry

Overview 

In the manufacturing sector, businesses share the common goals of cost reduction, waste minimization, and maximizing profitability. While some achieve these objectives, others fall short. Ever wondered what sets them apart?

Among many factors, one crucial determinant is the presence of a quality culture. Successful manufacturing businesses understand that quality management plays a pivotal role in achieving these goals. Also, read: Difference between Quality Management and Quality Control.

Quality management holds particular significance in manufacturing due to heavy regulations and high stakes involving costs and brand reputation. With various challenges emerging from internal and external factors, the need for effective quality management is evident.

Manufacturing businesses require a quality management software tailored to their needs. Such software fosters a culture of quality within operations, aiding in achieving business objectives. But before diving deeper, let’s establish the basics of QMS. Also, read: What is the difference between Quality Control and Quality Assurance?

What is a Manufacturing Quality Management System?

A Quality Management System in manufacturing aligns with the broader concept of quality management. Essentially, quality management refers to the methodology enabling businesses to design and deliver products or services that meet specific quality and compliance standards. It ensures the efficiency, effectiveness, and cost-effectiveness of quality processes.

A QMS functions as a tool that harmonizes people, processes, and documentation within an organization. Serving as quality control software for manufacturing, it fosters interaction among these elements.

Primarily, a QMS in manufacturing involves establishing and implementing standard operating procedures (SOPs), business policies, corrective processes, and functions. Its core purpose is to consistently meet customer quality expectations.

At its core, a QMS ensures that products, processes, or systems consistently perform according to their intended functions without deviation.

What are the Challenges in Manufacturing Industry?

The manufacturing industry grapples with numerous challenges including heightened competition, globalizing operations, reducing cycle times for product launches, and maintaining top-notch quality standards. However, among these, the most critical hurdles are meeting regulatory requirements, managing costs, and enhancing customer satisfaction.

Remaining compliant poses a significant challenge for manufacturing businesses. They require a robust system to ensure their products and manufacturing processes comply with regulatory standards.

Cost management is equally daunting, as overlooking quality control can result in substantial losses due to increased manufacturing faults.

Additionally, enhancing customer satisfaction is a perpetual challenge. Businesses must continually improve their products, services, processes, and organizational culture to deliver the highest quality products and services, ensuring customer satisfaction.

In essence, addressing quality-related challenges in manufacturing necessitates effective coordination among people, processes, and technology. This is precisely the purpose of a QMS software!”

QMS system

Importance of Quality Management Software for Manufacturing

A quality management software tailored for manufacturing plays a pivotal role in addressing the array of challenges mentioned earlier. By offering a streamlined, paperless system, a QMS enables centralized monitoring and management of quality across operations. Consequently, it aids in faster and more efficient production of higher-quality products right from the initial stages.

A robust manufacturing industry quality management software is purpose-built to support continuous improvement and compliance initiatives. Aligned with guidelines like the Good Manufacturing Practice (cGMP) and other regulatory standards, it ensures the manufacturing of high-quality, risk-free products.

Furthermore, a quality software for manufacturing empowers businesses to exert proper control over manufacturing processes and costs. Its functionalities encompass:

  • Document Management: Centralizes and manages documents related to quality procedures, policies, and standards.
  • Change Management: Handles controlled changes to processes, documents, or systems while ensuring compliance and minimizing disruptions.
  • Nonconformance Management: Tracks and manages instances where a product, service, or process doesn’t meet specified requirements or standards.
  • CAPA Management (Corrective and Preventive Action): Addresses deviations and takes corrective measures to rectify issues while also implementing preventive actions to avoid recurrence.
  • Audit Management: Facilitates planning, scheduling, conducting, and tracking of internal and external audits to ensure compliance.
  • Training Management: Manages employee training related to quality procedures and standards.
  • Complaint Management: Handles customer complaints, tracks resolution processes, and identifies opportunities for improvement.
  • Risk Management: Identifies, assesses, and mitigates risks associated with quality processes, products, or systems.
  • Compliance Management: Ensures adherence to relevant regulatory requirements, industry standards, and internal policies.

These functionalities drive substantial value for manufacturing businesses, ensuring efficient operations and adherence to quality and compliance standards.

Advantages of Using Manufacturing QMS Software

The introduction of a manufacturing industry quality management software to any manufacturing business helps them leverage numerous benefits. Some of them are:

  1. Better Control: Enables comprehensive oversight and control across operations.
  2. Compliance with Industry Standards: Ensures adherence to industry-specific regulations and quality standards.
  3. Increased Production: Enhances efficiency, leading to improved production rates.
  4. Lesser Rework: Reduces the need for reworking or correcting errors, saving time and resources.
  5. Highest Quality Standards: Enables consistent delivery of high-quality goods.
  6. Cost Reduction: Minimizes costs linked to low-quality products or processes.
  7. Operational Excellence: Drives efficiency and effectiveness in operations.
  8. Exceed Customer Expectations: Improves customer satisfaction by meeting or exceeding their expectations.
  9. Continuous Improvement: Facilitates ongoing enhancements to product quality and processes.
  10. Improved Internal Communication: Fosters better communication and collaboration within the organization.

These advantages collectively empower manufacturing businesses to elevate their quality standards, streamline operations, and enhance overall performance.

Closing thoughts

A quality management software tailored for manufacturing encompasses a multitude of functionalities, addressing quality challenges while offering a plethora of benefits. This empowers manufacturing businesses to stay competitive and excel in their industry.

Among these solutions, QualityMaster stands out as an exceptional QMS software. Its comprehensive features and value make it indispensable for any manufacturing business. Interested in exploring its capabilities?

Reach out to our in-house quality specialists today to schedule a demo or engage in a no-obligation discussion.

What is CAPA in Quality Management?

Chirag Panjwani on February 3, 2022

Corrective Action Preventive Action

We invariably go for quality products and services. When it comes to dining out, we choose to eat at a restaurant that offers the best quality food. When it is about selecting the personal care & cosmetics products, we pick the brand that’s renowned for its top-quality products. And when we fall ill and require medical attention, we opt for the hospital known for its quality healthcare services.

Why? Because quality inspires trust.

When we eat out, when we apply beauty products, and when we opt for healthcare services, we place our trust in the brands that we expect will offer us products/services of highest quality, without any fault. And while all brands are fallible, the best ones ensure they conduct a rigorous investigation to identify the cause of the failure and fix it with a corrective action that prevents its recurrence.

What is Corrective Action Preventive Action (CAPA)?

Well, we just defined CAPA above for you. Corrective Action Preventive Action (CAPA) is a process which identifies a problem, investigates its root cause, and resolves it by taking corrective action as well as preventing its recurrence in future through preventive action, which is also the ultimate objective of the CAPA process.

The CAPA process consists of set of actions for improvements to an organization’s processes to eliminate the causes of non-conformities, which could range from a customer complaint, equipment failure, deviations, defects, to misinterpretation of written instructions to carry out work. It can be applied in disciplines such as manufacturing, product designing, distribution, shipping, and packaging, etc.

The two pillars of CAPA process, which are distinct yet related, involve corrective action, i.e., the action taken to eliminate the causes of non-conformities, and preventive action i.e., the action taken to avoid the occurrence of such non-conformities. In order to ensure these two actions are effective, it becomes important to conduct systematic investigation of the root causes of failure.

CAPA in Quality Management

CAPA process is an inherent part of the overall quality management system (QMS). In fact, CAPA in quality management is a required part of ISO compliance and is an essential part of Total Quality Management (TQM) practices for any organization which wishes to achieve its objective of zero defects. 

Both corrective action and preventive action should be part of a seven-step process, which begins with capturing, recording and identifying the actual or potential non-conformity, and further involves its evaluation, analysis of the root cause, and proactive measures such as risk assessments, audits, and inspections, etc. 

Take a look at those seven steps below:

1. Identification

The QMS system comes with the capability to identify the problem in this first step of the CAPA process, facilitating appropriate documentation of the issue at hand. This includes an accurate and complete description of the problem i.e., what the problem is, when, where, why and how did it occur, and what the extent of the problem is. 

2. Evaluation

This step involves performing risk analysis of the problem described and identified above, based on compliance risk, and any potential risk to the organization or customers. This is done to determine the need for action, its urgency, and the level of action needed in order to solve the issue. This step is the point where the CAPA request gets actioned or denied.

3. Investigation

The next step is about investigating any confirmed problem that has been identified and determining its root cause. Most significant part of CAPA in quality management, this process begins with documenting the actions that will be taken, their objective, the procedure to be followed, people who’ll be involved in the investigation, any other resources that will be required during the process, and its outcome.

4. Root cause analysis

Once the root cause has been identified, the next step is to analyze the root cause along with its contributing factors and perform the risk assessment accordingly. A QMS system allows listing down multiple root causes for an issue in addition to the resolution required and the result and allows recording the complete investigation and analysis report for future reference.

5. Planning the resolution

Once the root cause analysis has been performed, proposed corrections should be worked upon, and an action plan to correct/contain/ the problem and prevent it from happening in future, should be developed. This step also enables organizations to take a broader look at the issues by allowing proactive review of the processes and procedures.

6. Implementation

This phase involves the implementation of the action plan – right from initiation of the tasks listed and described in the action plan, their completion, to their documentation. This step confirms that the CAPA process is now fully at work to resolve the cause of nonconformity, and also to eliminate the cause of potential nonconformity in the future.

7. Follow-up

This step brings a closure to the CAPA process. It is basically a properly documented follow-up procedure, which intends to validate or verify the effectiveness of the entire process, which includes determining if all the tasks have been completed, nonconformities have been resolved, and verifying whether the actions taken have been effective, and they haven’t created new areas of inconsistencies.

Why is CAPA management important?

CAPA management holds special significance in the manufacturing industry, where quality management issues can have an immediate and significant impact. If the organizations fail to follow the CAPA procedures and determine the root cause of compliance issues, it can result in repeatable problems at unavoidable costs. So, it becomes extremely important to diagnose the problem, fix it at the earliest, and prevent its recurrence in the future.

By implementing CAPA management software, enterprises can have a structured and measurable improvement process that can identify the root cause of the problems, product, or workflow, to make informed decisions regarding action plans to be implemented for their effective resolution.

In doing so, the organizations can successfully mitigate adverse effects which could range from worker hazard, costly downtime, faulty products, and failure to comply with regulations, etc.

How QualityMaster’s CAPA Management Software help businesses? 

Failures are inevitable. However, addressing the non-conformances, customer complaints, and deviations in the most efficient manner is the key to correcting those failures, as ineffective complaint handling can hurt brand reputation and customer relationships. 

Therefore, a corrective and preventive action system is a necessity for businesses. The right QMS CAPA software can help businesses build a strong basis for effective CAPA, as well as complaint handling. One QMS CAPA software that stands out among the crowded corrective action software space is QualityMaster. 

A quality management software that acts as a corrective and preventive action software, it is designed for growing manufacturing organizations. Schedule a demo today to learn more about how QualityMaster can help your organization implement a CAPA process, by writing to us.