February, 2022 - QualityMaster

Different Types of Quality Management Systems

Anmol Pandit on February 23, 2022

The renowned art critic John Ruskin’s insight resonates across industries, highlighting the essence of deliberate effort and meticulous planning in achieving and sustaining quality, be it in art or business. In today’s fiercely competitive landscape, an organization’s commitment to consistently upholding high-quality procedures and products significantly influences its prospects for success.

Quality, as Ruskin aptly observed, isn’t a happenstance occurrence but a deliberate pursuit. It necessitates continual efforts, thorough analysis, and a dedicated commitment to improvement.

Enhancing your Quality Management System (QMS) stands as one of the most valuable investments an organization can make. Strengthening this system serves as the bedrock for delivering top-notch products and services while fostering a culture of quality excellence throughout the organization.

In essence, a robust and evolving Quality Management Software not only ensures the delivery of superior products and services but also fosters a competitive edge, customer satisfaction, and long-term success in today’s dynamic business landscape.

A Quality Management System is Beneficial for a Variety of Reasons.

A Quality Management System (QMS) refers to a structured framework of policies, processes, procedures, and resources established within an organization to ensure it consistently meets and exceeds quality standards in its products or services.

When discussing different types of QMS, it’s essential to recognize that various standards or methodologies exist, each offering a unique approach to achieving and maintaining quality. These standards aim to guide organizations in implementing effective quality management practices.

Some Notable QMS Standards and Methodologies Include:

ISO 9001: One of the most recognized international standards for QMS, emphasizing a process-oriented approach to quality management, customer satisfaction, and continuous improvement.
Six Sigma: A methodology focused on reducing defects and variability in processes by using statistical methods to achieve near-perfect results, often aiming for no more than 3.4 defects per million opportunities.
Total Quality Management (TQM): A holistic approach that involves all employees in continuous improvement to meet or exceed customer expectations. TQM emphasizes customer focus, continuous improvement, and employee involvement.
Lean Manufacturing: A methodology primarily focused on minimizing waste and maximizing value through continuous improvement efforts, streamlining processes, and optimizing efficiency.
Capability Maturity Model Integration (CMMI): Primarily used in software and systems engineering, CMMI provides guidelines for improving processes and capabilities within an organization.

Understanding these different methodologies allows businesses to assess and choose the QMS that aligns best with their goals, industry requirements, and organizational culture. Each approach has its unique strengths and focuses, catering to various business needs and objectives.

What is Quality Management Software?

Quality Management Software facilitates the coordination of processes, policies, procedures, documentation, and resources essential for meeting customer needs and expectations.

As industrial manufacturing expanded, Quality Management Systems emerged to ensure consistent outcomes amid higher volumes and increased specialization.

Today’s market demands precision, speed, and scalability, necessitating Quality Management Software to reduce errors, minimize delays, and enhance customer satisfaction. Notably, the concept of quality has broadened to encompass environmental and privacy concerns alongside production standards.

Modern QMS requires collaboration among people and efficient allocation of capital and resources. This underscores the need for dedicated QMS system.

For implementing a QMS or achieving specific quality compliance, choosing a suitable Quality Management Software from the options listed below is vital.

Types of Quality Management System

The ISO systems stand out as the most prevalent and referenced types of quality management solutions and standards.

The ISO family of quality standards finds application across diverse industries, addressing both quality and sustainability. While ISO 9001 stands as the globally recognized and widely adopted standard, specific industries may benefit from additional accreditations and standards tailored to their requirements.

Despite varying quality levels across industries, they often share common principles and employ similar quality statements, as illustrated above.

While many companies prioritize meeting these quality standards and management systems, efficient coordination and management of these components become crucial, particularly in complex operational scenarios. This is where the ‘types of quality management software‘ play a pivotal role.

Key Takeaway

Implementing a QMS system is vital for embedding quality across a company’s operations and products. The choice of system depends on the company’s specific quality criteria, with ISO 9001 being among the most prevalent standards.

Build a robust QMS for your company today and set yourself apart in a competitive landscape. Contact us now to get started!

Key Metrics That Drive Higher Manufacturing Quality

Sanjay Panjwani on February 7, 2022

In all our previous blogs, we have discussed how quality is the most important attribute people look for in a product or service, and it is that predominant factor that decides the fate of products, services, as well as brands.

It is essentially why the business organizations across the globe focus on understanding the multi-layered concept of quality, and delivering it by inculcating a culture of quality within the organization, and integrating it throughout their operations.

This strategy of focusing on quality with the same intensity though each process, operation, and all the organizational resources helps them grow faster than their competitors, gain market share, and thwart price wars. And this holds true for organizations of all types and sizes…

…Including the manufacturing organizations

Quality gains greater significance in the manufacturing industry, where it is one of the biggest factors that determines customer satisfaction. Nobody wants to buy a product that’s prone to breakage, or might need to be replaced shortly after the purchase.

When we talk specifically about the process manufacturing industries such as pharmaceutical, food & beverage manufacturing, etc., within the broader manufacturing category, quality gains all the more significance, with the health of the consumers at stake.

Additionally, in these manufacturing businesses, poor quality of the products negatively impacts the manufacturing operations, as it can prove to be a costly proposition for the manufacturers to perform re-work on items that don’t meet quality standards.

Hence the need to drive higher manufacturing quality

More than any other industry, the manufacturing industry finds it paramount to maintain the quality standards of the products. In fact, it is one of their most essential responsibilities to ensure that the final output is safe, durable, and complies with all internal/external quality standards.

But when we talk about driving higher manufacturing quality, it is easier said than done. It may sound like an easy thing and a simple process, but in reality it is a complex thing to achieve. To begin with, it requires a thorough assessment of the manufacturing plant’s quality performance, which in turn relies on many metrics.

These metrics help identify whether you are producing a high number of quality products in the most efficient manner, and gain complete understanding of the current quality performance of your production facility while highlighting areas of improvement.

But, in the first place, what are metrics?

Manufacturing metrics or Key Performance Indicators (KPIs) are well-defined and quantifiable measure that the manufacturing businesses use to gauge their performance over time. These metrics can be defined as data and numbers that are indicator of a manufacturing company’s actions, abilities, and overall quality.

Organizations use these performance indicators to monitor, analyze, and optimize their manufacturing operations, and also to compare their efficiencies with those of their competitors. There are many different forms of metrics, and some examples include profit, return on investment, market share, customer satisfaction, customer reviews, and process excellence, etc.

These metrics are integral to an organization’s success, and hence it is important to track, manage, and eventually, improve them. Let’s understand the key metrics that can be measured, analyzed, and improved upon so as to drive higher manufacturing quality, in detail, and some others, in brief.

Metrics related to quality improvement

There are a few metrics that are directly related to quality improvement, such as yield, customer rejects/returns, and supplier’s quality incoming. Yield is the most basic quality performance metric for manufacturing businesses, as it reveals the percentage of quality products manufactured at a factory within a given time period.

Customer rejects/returns is a measure of the number of times customers reject or request a return for a product after it fails to meet the desired specification. Supplier’s quality incoming, on the other hand, suggests the percentage of good quality raw materials coming into the manufacturing process from a particular supplier.

Metrics related to customer satisfaction improvement

Customer satisfaction is another valuable measure of product quality. There are a few metrics that are a good indicator of the overall customer experience, and can help improve their satisfaction levels. Customer complaint is one such metric, which when tracked and addressed properly can throw light on areas of improvement and bring down quality control issues in future.

Then there are few other customer satisfaction metrics, such as your churn rate and the cost of customer acquisition. Then there’s also the ‘On-Time Delivery to Commit’ metric, which indicates the percentage of time when a completed product was delivered on the schedule that was committed to customers.

Metrics related to efficiency improvement

A few metrics such as throughput, capacity utilization, overall equipment effectiveness (OEE), etc. are a good indicator of an organization’s efficiency. While throughput measures what quantity of product is being produced on a machine, or plant over a defined period of time, capacity utilization indicates the total manufacturing output capacity which is utilized at any given point in time.

OEE takes into consideration availability, performance, and quality, and can be used to suggest the overall effectiveness of production equipment or an entire production line. Schedule attainment is yet another metric which indicates the percentage of time a target level of production is attained within a specified schedule.

Metrics related to compliance improvement

For an industry with so many moving parts, maintaining compliance is absolutely non-negotiable for manufacturing businesses. Hence, it is important for the manufacturers to track, measure, and manage key metrics related to compliance improvement, which eventually help drive higher manufacturing quality.

Metrics such as reportable health and safety incidents, which is an indicator of the number of health and safety incidents recorded in a defined period of time, and non-compliance events / year, a measure of the number of times a plant went outside the guidelines of normal regulatory compliance rules during a year, to operate, are also useful metrics.

Metrics related to cost reduction and profitability improvement

There are quite a few important metrics that impact cost reduction and improve profitability, and thus drive higher manufacturing quality. To name a few, ‘Total Manufacturing Cost Per Unit Excluding Materials’, ‘Manufacturing Cost As A Percentage Of Revenue’, ‘Net Operating Profit’, ‘Productivity In Revenue Per Employee’, and ‘Cash-To-Cash Cycle Time’, etc., are some of them.

Few more metrics that hold importance in manufacturing

Scrap rate
Cycle time
Demand forecasting
Inventory turns
Changeover time
Machine downtime rate
Inventory accuracy
Rework, etc.

QMS for manufacturing industries can help drive manufacturing quality

This list can still be expanded a bit further, depending on the need. But it should have given you a fair idea on what all metrics you should be measuring and monitoring in your manufacturing organization to make it a world-class manufacturing company that continuously strives for overall quality improvement.

Attaining higher quality levels has a tremendous effect throughout the organization, as everything is co-related. Reduced manufacturing cycle time improves order performance, which increases customer satisfaction, and in turn leads to more sales, reduction in cost of quality, as well as costs per unit of production excluding materials.

A good manufacturing quality management software such as QualityMaster can help your manufacturing organization drive higher manufacturing quality by executing the metric strategy, as well as all the quality initiatives from the top floor to the shop floor, to perfection. For any queries directed towards our in-house metric & quality experts, contact us here.

What is CAPA in Quality Management?

Chirag Panjwani on February 3, 2022

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.