The Ultimate Guide to Quality Management

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 Walter A. Shewhart and later implemented by W. Edwards Deming during World War II.

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 their customer base. 

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.

1. Improves Organizational Processes
   All businesses have goals that they need to meet, including customer service, fulfillment, sales, and purchasing.  A QMS ensures that organizations meet these goals efficiently and effectively. When an organization communicates its goals and its action plans, organizations become more effective.
2. Improves Customer Satisfaction
   Over the past decade, influenced by the onset of social media, the consumer’s perception of quality has become increasingly relevant to manufacturers. Meeting customer expectations is vital to the success of a business and a properly designed QMS makes customer satisfaction a priority. It collects customer feedback and uses it to constantly improve customer satisfaction.
3. Improves Compliance
   Heightened scrutiny and restrictions across key markets like China and the EU are expected to continue through 2019 and beyond, making compliance a priority across all organizations. By integrating compliance to standards and regulations into a QMS, including into the documentation and auditing system, organizations can ensure that they’re always meeting global regulatory requirements.
4. Improves Organizational Culture
   When employees are unclear of expectations and goals, it can create a culture of uncertainty, fear, and resentment. Clear, defined roles, accountability of management, and established training systems for the success of the business are all part of fostering an effective employer/staff relationship.
5. Improves Documentation
   Poor documentation can put a company at massive risk. By clearly documenting all activities and processes, you'll be able to easily identify non-conformances and adjust your processes accordingly.

What are the main principles of quality management?

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:

1. Customer Focus - The primary focus of Quality Management should be understand, meet and exceed the needs of existing and future customers. Organizations should align their objectives and goals with customer requirements.
   
   
2. Leadership - Organization leadership and management should establish a purpose and direction for the organization. They should engage employees, recognize their contributions and equip them with the tools and training needed to achieve the company’s quality objectives.
   
   
3. Engagement of People - Businesses should help foster competent, empowered and engaged people at all levels throughout the organization in order to enhance its capability to create and deliver value.
   
   
4. Process Approach - Leadership and employees should all understand what the activities are and why they are important. The activities should be managed as interrelated processes that function as a coherent system in order to ensure consistent and predictable results.
   
   
5. Improvement - All organizations must focus on continual improvement to improve performance and capabilities. All levels should be empowered to make improvement and these improvements should be measured consistently.
   
   
6. Evidence-based Decision Making - Companies should make decisions based on accurate and reliable data.
   
   
7. Relationship Management - To sustain growth, organizations should build and manage relationships with interested parties, such as suppliers. They should recognize supplier successes and elaborate on improvement and development activities.

• Document Control - A document control process is an essential part of compliance requirements in regulated industries subject to GxP and ISO standards. Employees and partners should be able to author, collaboratively review, approve and release documents. Users must also be able to easily and securely access the most current version of any document and collect audit trail.
• CAPA Management - Corrective and preventive action (CAPA) is the core of any quality system. The ability to investigate, collect and prevent the recurrence of non-conformances is vital to achieving regulatory compliance. CAPA management systems can increase product quality and safety, increase customer satisfaction and entire global compliance.
• Change Control - Change control ensures that any changes to your QMS are controlled and coordinated, reducing the possibility of unnecessary changes.
• Audit Management - Audits of processes and systems are essential to gauging their effectiveness. Incorporating audit management into your processes can help ensure that quality standards are being met and being improved.
• Supplier Quality Management - As globalization and externalization barrel forward, more and more companies are facing the challenge of managing an extensive network of international suppliers. A supplier management system enables all parties, internal or external, to work together through supplier certifications, audits, corrective actions, and performance monitoring. This not only improves quality and ensures ongoing compliance, it also helps to increases supplier accountability and collaboration.
• Training Management - Leadership and employees should all understand quality processes and why they are important. Employees should always be up to date with training requirements, and your organization should maintain training records in accordance with internal policies and external regulations and standards.
• Compliant Management - Providing excellent customer experience is paramount to company success. Your Quality Management software system should have an effective compliant management to address any issues as they arise. Complaints may indicate serious safety and regulatory compliance issues that must be dealt with in a timely manner.
• Risk Management - Stay ahead of potential issues and minimize compliance risk throughout your organization. Your Quality Management software system must allow you to easily manage enterprise and operational risks to remain compliant with the most up-to-date requirements for risk-based decision making. Potential features of this essential component include the ability to use risk registers and risk matrices, list and assess potential risk events or opportunities, evaluate severity and probability, prioritize mitigation activities, and track to completion. 

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. 

Quality Considerations for Cosmetic Manufacturers

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:

1. Compliance: While cosmetics don’t require FDA approval before they go to market, manufacturers have a legal responsibility to ensure that their products are safe for consumers and meet all regulatory requirements, including ingredients and product labeling. With immediate access through social media, news gets out fast impacting brand trust. Which brings us to our next item.
2. Maintaining Trust: Consumer brand trust is developed through product effectiveness, consistent quality, cost, and shared values. One bad experience can impact an entire brand. In this competitive landscape, cosmetic companies must ensure they stay ahead of any issues and be proactive in their messaging and response.
3. Supplier Management: With an ever expanding supply chain, control has never been more important. When suppliers’ or contract manufacturers’ product consistency or quality is lacking, it’s the brand that takes the hit. Cosmetic manufacturers need clear communication and open collaboration with their external partners to ensure their requirements are being met.
4. Scalability: As business grows, the ability to scale while maintaining quality is imperative. Manufacturers must plan ahead to ensure they don’t outgrow controls and processes. This includes determining the appropriate resources and technology are in place to guarantee success.

Quality Challenges for Cosmetic Manufacturers

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:

Challenge #1: International Regulations

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.

Challenge #2: Claims Substantiation

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.

Challenge #3: Testing and Ingredient Requirements

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.

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:

1. Efficiency - Specialty Chemical companies operate in highly competitive markets and need a system that eliminates low value work, increases manufacturing ROI and reduces risk.   The ability to manage, track and automate global compliance related activities, identify QHSE process bottlenecks and provide easy, secure access to employees, contractors and external stakeholders to processes, documents and data within a single application is essential to maximize operating costs and returns.  
2. Speed - Systems that provide business acceleration e.g. automating approval of CoAs, CAPAs and Incident Management also unlock data sets that enable better decisions, faster.  This enables businesses to quickly mine facts and understand trends that let them move forward with confidence. 
3. Collaboration - With extended supplier networks around the world, enhanced collaboration and reduced supplier risk are crucial to success. Suppliers play a big role in ensuring compliance. They need secure access to supplier-related information such as specifications or agreements. Integrating suppliers directly into compliance processes without any media break is essential - e.g. for responses to supplier corrective actions or audit findings. Managing supplier qualification activities and monitoring supplier performance with real-time dashboards and reporting in one system will help to improve product 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.