Quality Management (and TQM) focuses not only on the quality of the outputs (products & services) but also the inputs - the tasks and processes by which the outputs were created. Ideally, the quality of a product and/or service is not only increasing but the process by which the product and/or service is created is becoming better, thus achieving more consistent, higher quality products and services.
So where exactly did Quality Management come from? When did people start managing quality? And how has Quality Management evolved?
Though Quality Management (and TQM) seem like a recent phenomenon, its roots can be traced back to the likes of Eli Whitney, Frederick Winslow Taylor and Henry Ford. Each of these illustrious craftsmen had their own input into what we call Quality Management today. Whitney popularized the use of identical (and interchangeable) parts to be used to manufacture muskets in an assembly line. Taylor, who was one of the intellectual leaders of the Efficiency Movement, contributed ideas such as standardization and adopting improved practices. Ford further perfected these ideas and implemented them into his assembly lines when he began creating the first 'affordable' automobile of the 20th century.
It wasn't until the 1920's that the concept of Quality Management made strides in businesses when statistical methods began being leveraged in a method of quality control for production. This method, called statistical quality control, was developed by
Japan began adopting the concept of Quality Management in the 1950s and 1960s in an effort to re-build its economy and dismantle the notion that Japanese goods were synonymous with cheapness. Japanese engineers and manufacturers sought the independent help of Deming and Joseph Juran. Deming for his contributions to the methods of statistical quality control, and Juran for his contributions to the concept of managing for quality.
With the help of Deming and Juran, the Japanese economy boomed from the 1970s onward. The philosophies and methods of Quality Management came back to the U.S. in the 1980s when Ford Motor Company recruited Deming to start a quality initiative so they could catch up to the now highly efficient, TQM-focused Japanese manufacturers.
Today, Quality Management is alive and well. Advancements in technology (social media, feedback processes, etc.) have made Quality Management a necessity for any company looking to be competitive and grow
Philosophies and processes will continue to be developed so long as there are customers to satisfy and companies will need to be able to evolve and adapt to stay relevant in the realm of Quality Management.
A Quality Management System (QMS) is a formalized system that documents policies, processes and procedures for achieving quality policies and objectives. QMS systems help businesses coordinate their activities to meet customer expectations, regulatory and compliance needs and improve the efficiency of its processes.
ISO 9001 is the the most prominent approach to Quality Management Systems and helps standardize how a QMS is designed.
Since quality is the key competitive differentiator in today’s global markets, implementing a QMS helps ensure that your processes run effectively and efficiently, lower costs and reduce waste.
Today, to achieve synergy in all aspects of quality, businesses can implement enterprise Quality Management software that provides a centralized means of managing and tracking your Quality Management System (QMS).
READ MORE: Key Takeaways from the Gartner Market Guide for Quality Management System Software
The ISO 9000 family is a standardized set of rules for Quality Management Systems to help organizations ensure they meet all statutory and regulatory requirements while also meeting the needs of their customers. ISO 9001:2015 is the world’s most recognized Quality Management standard and is an example of a Quality Management System. Based on the idea of continual improvement, it outlines the ways an organization can achieve consistent performance and service.
Because ISO 9001 specifies the requirements for an effective Quality Management System, it comes with many benefits, including:
Although not a requirement, an organization, large or small, can get certified to the standard. There are over one million companies and organizations in over 170 countries certified to ISO 9001. Certification to the ISO 9001 standard can increase an organization’s credibility by showing customers that its products and services meet quality standards. The certification process consists of implementation of ISO 9001:2015 requirements and then completing a successful registrar’s audit.
READ MORE: Leadership and Performance Evaluation in ISO 9001:2015
The International Standard for Quality Management (ISO 9001:2015) has a number of management principles to guide organizations to better performance. The management principles are:
Outdated Quality Management software systems - whether paper-based or legacy software - are complicated, fragmented, and unable to fully meet today’s complex business and compliance requirements.
Modern QMS software solutions should be cloud based, easy-to-use, and must include the following components:
Customer satisfaction is the backbone of Quality Management. A consumer goods product that is developed without the needs of the consumer in mind will quickly fail. Though the consumer goods industry is experiencing fundamental changes, it remains one of the most competitive in the world. Consumer Goods organizations must ensure they are producing a quality product while simultaneously overcoming internal and external challenges.
These challenges include:
For companies that exist in the consumer goods industry, there are two factors of quality that will determine your success, outside of the regulatory environment: Perceived Quality and Actual Quality. Perceived Quality is the "customer's perception of the overall quality or superiority of a product or service with respect to its intended purpose, relative to alternatives. "
Below are the dimensions of Perceived Quality (i.e. how a consumer determines if a product is 'quality' or not):
1. Performance: How well does a lawn mower mow lawns?
2. Features: Does a body wash have a convenient dispenser?
3. Conformance with specifications: Are there any reported defects?
4. Reliability: Will the lawn mower work properly each time it is used?
5. Durability: How long will the lawn mower last?
6. Serviceability: Is the maintenance system efficient, competent, and convenient?
7. Fit and finish: Does the product look and feel like a quality product?
Actual Quality is the extent to which the product or service delivers on each of the 7 dimensions above. In a world where new innovations are disrupting the industry, social media has accelerated and amplified the consequences of any misstep, and new competitors are competing more than ever for consumers, it is increasingly important for companies to ensure that the perceived quality of their product or service aligns with its Actual Quality.
Consumer Goods organizations must first successfully position their brand in front of consumers by streamlining the product journey (speed), providing end to end visibility (insight), and ensuring compliance with the latest standards (reducing risk). Then, they must ensure their product or service can deliver on all of the dimensions of perceived quality. Finally, companies must develop an ongoing relationship between brand and consumer (i.e. customer loyalty) because this is just as important as developing a quality product or service. Customer loyalty is driven by product quality and companies that fail to deliver on product quality expectations will find themselves quickly losing revenue, profitability and market share.
As many cosmetics companies have learned the hard way, consistently producing a high-quality product is no easy feat. Every year there are hundreds of recalls for cosmetics products in the US and EU, more for products presenting a chemical risk to consumers. And hand in hand with product quality is ensuring that each product is compliant with numerous levels of regulations before entering each unique market.
With the rise of social media and new technologies, consumers today are more informed and selective in purchasing from brands. Cosmetics companies are feeling the pressure to build brand loyalty and get new products out into the markets faster, while maintaining compliance and operational costs.
In this increasingly competitive market, quality issues can make or break a cosmetics brand. And with multiple suppliers, contract manufacturers (CMOs), product lines and global regulatory agencies, understanding the importance of Quality Management the the cosmetics industry can become very complicated. Below are some of the top items that Cosmetic Manufacturers must consider when it comes to integrating Quality Management into the business:
As seen above, every industry comes with its own Quality Management considerations: how can Quality Management benefit your business in everyday operations? The same is true for industry challenges: what challenges (internal or external) can be solved by implementing a better Quality Management process and/or a better Quality Management System (QMS)?
Veeva's partners Cosmetic Compliance conducted a cosmetic industry survey of 600+ industry leaders highlighting the top three compliance challenges facing cosmetic brands, including:
International regulations are the largest compliance challenge for cosmetic brands in 2019, with 60% of survey respondents indicated this as their largest challenge.
As those in the cosmetics industry know all too well, international regulations rapidly change, which means regulatory and quality officers have to continuously stay up to date. Just last year, China announced the establishment of the State Administration for Market Regulatory (SAMR) which covers cosmetics as well as food and drugs. As the second largest cosmetics market globally, the impact of tighter safety monitoring and new cosmetics classifications is still rippling through companies operating in or seeking to enter the Chinese market.
The survey found claims substantiation to be the second largest compliance challenge for cosmetic brands in 2019, with 49% of respondents indicating this challenge on a company-wide level and 52% indicating it on an individual level.
Claims substantiation is a growing industry challenge due to the increasing popularity of “natural” and “organic” cosmetic products. Presently, there is no formal definition for “natural” products in cosmetics, which has increased the potential risk factor for claims. That being said, it’s difficult in today’s regulatory climate to write truthful claims supported by adequate scientific evidence with no formal definition for “natural” cosmetic products.
The third largest compliance challenge for cosmetic brands in 2019 is testing and ingredient requirements, with 41% of respondents indicating this challenge on a company-wide level and 39% on an individual level.
This challenge can be largely attributed to the two new bills regarding testing and ingredient requirements that have come to light in recent years. The first bill, known as the bipartisan Personal Care Products Safety Act3, sponsored by Sens. Dianne Feinstein (D-CA) and Susan Collins (R-ME), would give the FDA more oversight over the industry in general. This bill would require the FDA to test at least five ingredients a year for safety; companies would have to submit their ingredient lists to the FDA; and companies would be required to report adverse events to the FDA, among other things. Sen. Orrin Hatch (R-UT) has also proposed a cosmetics safety bill, known as the FDA Cosmetic Safety and Modernization Act.
So what’s the solution? How can cosmetics companies mired in old processes, limited technologies and slow-moving product journeys possibly hope to accelerate time to market while also remaining compliant with ever changing regulations?
Having a unified cloud-based QMS software can makes this all possible – eliminating the need for emails, spreadsheets, siloed data and providing a single unified view of every step of the product journey from regulatory to quality to marketing.
Crop Sciences companies have driven a revolution through digital farming. Now is the time to revolutionize product compliance using unified, digital solutions for Product Quality and Health, Safety and Environmental (HSE) to accelerate innovation, reduce risk and maximize the customer product experience.
Crop Science companies face unprecedented oversight and restrictions and need advanced Quality and HSE solutions (QHSE, EHSQ) to ensure compliance with external requirements from customers and from agencies like EPA and ECHA as well as compliance with internal requirements like specifications and sustainability goals.
Let's take a look at the top considerations for Crop Science companies in regards to QHSE Management and maintaining compliance:
Quality and HSE Management plays a vital role in bringing safe and compliant crop science products to market. Systems that cannot deliver efficiency, transparency, real time data, full compliance and flexibility reduce competitiveness. A loose combination of spreadsheets, email, and locally stored files that are laden with risk, prone to errors and inefficient does not constitute a world-class Quality Management solution.
Specialty Chemicals companies at the epicenter of sustainable innovation. They form the bridge between nature’s resources and the products we consume, are leaders in the transformation to circular economies and must collaborate closely with value-chain partners.
Successfully delivering sustainable innovation needs speed-to-market, cost control and high quality, safer products. Underpinning sustainable innovation are transparent Quality and Health, Safety and Environmental Systems (QHSE, HSEQ, EHS, SHE, HSE) that maximize ROI and speed whilst reducing risk.
Let's take a look at the top considerations for Specialty Chemical companies in regards to QHSE Management and maintaining compliance:
Quality and HSE Management plays a vital role in bringing sustainable Specialty Chemicals products to market. Systems that cannot deliver efficiency, transparency and collaboration reduce competitiveness. A loose combination of spreadsheets, email, and locally stored files that are laden with risk, prone to errors and inefficient does not constitute a world-class Quality and HSE Management solution.
Veeva QualityOne is a unified cloud QMS solution that includes document control and Supplier Quality Management (SQM) in a complete and easy-to-use application. It helps companies accelerate time to market, keep pace with new entrants AND protect brand equity - without compromising compliance.
The QualityOne product supports:
Founded in 2007, Veeva Systems is a global provider of industry-specific cloud-based software solutions that address the unique operating challenges and regulatory requirements of companies in the Life Sciences & Consumer Products industries. Our cloud-based solutions have helped hundreds of market-leading companies eliminate inefficiencies and bring high-quality, trusted, products to market faster without compromising safety or compliance.Learn more about Veeva's Solutions