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    The Ultimate Guide to
    Quality Management

     

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    What is Quality Management?

    Quality Management is the exercise of overseeing the activities, tasks and processes (inputs) that are used to create a product or service (outputs) so they may be held to a high and consistent standard. There are four main components of Quality Management: quality planning, quality assurance, quality control and quality improvement. The process of implementing all four components in an organization is referred to as Total Quality Management (TQM).

    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.

    History of 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.

    LEARN MORE: 4 Quality Trends That Will Impact Your Role in 2019

    Quality Management Inspection

    What is a Quality Management System (QMS)?

    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: 3 Components of an Effective QMS Software

    What are the Benefits of a Quality Management System (QMS)?

    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 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.
    Depositphotos_127356870_xl-2015

    What is ISO 9001:2015?

    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:

    • Organizing a Quality Management System (QMS)
    • Meeting the necessary statutory and regulatory requirements
    • Cutting costs and reducing waste
    • Improving customer and employee satisfaction
    • Continually improving organizational processes
    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.

    7 Principles of ISO 9001:2015

    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. ISO 9001 7 principlesCustomer 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.

    Learn more about Veeva's ISO 9001:2015 Certification

    modern-qms

    What are the Requirements of Modern Quality Management Software Solution?

    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:

    • Complete and Unified Application - Siloed and disconnected QMS systems not only waste time and money, but they can also put an organization at risk. Bringing all quality processes, document management, data analysis and training into a single unified software can increase visibility and reduce risk. It also gives managers, employees, contract manufacturers, suppliers, and auditors all access to a single application, which can improve collaboration and provide users with better control.
    • Visibility - In today’s complex and competitive markets, organizations need to be proactive in identifying, preventing and fixing inefficient processes as they are happening, rather than after the fact. Modern Quality Management software should include real-time visibility into all quality activities to eliminate delays in quality analysis.
    • Control - Leaving sensitive data unprotected and accessible to anyone exposes organizations to significant risk and subsequent financial and reputational consequences. Modern Quality Management software must allow companies to easily control access, visibility, and permissions to make sure that only the right people take the right actions at the right time, without compromising data integrity or history.

    See Why Cloud Matters for Quality

    Essential Components of Quality
    Management Software Systems

    • 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. 

    Quality Management & Consumer Goods

    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:

    • Evolving consumer trends
    • Ongoing regulatory changes
    • New product formulations and packaging technologies
    • Expanding geographical markets
    • New, more agile competitors
    • Expectations to achieve profitable growth year after year

    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. 

    Quality Management and Cosmetics

    As many cosmetics companies have learned the hard way, consistently producing a high-quality product is no easy feat. Just last quarter, there were eight recalls for cosmetics products in the US and 20 in the EU, most 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 at Cosmetic Compliance recently released the results of a cosmetic industry survey of 600+ industry leaders highlighting the top three compliance challenges facing cosmetic brands this year:

    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.

    Read more: New Report: Top 3 Compliance Challenges for Cosmetic Brands in 2019

    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.

    Quality Management & Chemical

    As with the Consumer Goods and Cosmetics industries mentioned above, the Chemicals industry is experiencing some large transformations as well. Global markets, faster production cycles and changing regulations are just some of the trends that have taken shape.

    While these trends may present challenges for some chemical companies, others embrace them as opportunities to create better, safer and more sustainable chemical products. Those companies that are prepared have realized the importance of Quality Management in their industry.

    One of the biggest challenges that Chemical companies have to overcome is having to produce quality products while faced with increasingly strict regulations that differ from country to country. Whether it’s complying with the Toxic Substances Control Act (TSCA) or following good laboratory practices (GLP), managing regulatory requirements and consistently producing a high quality product becomes very complicated.

    Let's take a look at the top considerations for Chemical companies in regards to Quality and Compliance:

    1. Visibility - Chemical companies require a system in which they can clearly manage and track global regulatory submission activities, ensuring compliance. They also need constant insight into their quality processes, documents and data within a single application that can be securely accessed by employees, suppliers, contract manufacturers and auditors.

    2. Control - Chemical companies must be able to easily control access, visibility, and permissions to make sure that only the right people take the right actions at the right time, without compromising data integrity or consistency. Having the ability to document changes ensures performance, reliability, and safety and guarantees that all processes meet quality and compliance standards.

    3. Efficiency - With thousands of regulations to comply by in dozens of countries around the world, keeping track of documents and submissions can become difficult. Chemical companies need an effective document management system ensures efficiency and helps to reduce errors and costs. Moreover, achieving efficiency has a direct impact on the time it takes to release new products to markets. An efficient system enables reduction in time to market which translates to significant cost savings and increased revenue.

    Quality Management plays a vital role in bringing safe and compliant chemical products to market. A loose combination of spreadsheets, email, and locally stored files that are laden with risk, prone to errors and inefficient does not constitute a chemical-grade Quality Management solution. 

    About Veeva QualityOne

    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:

    • Document Control
    • Nonconformance and Investigation
    • Complaint Management
    • CAPA Management
    • Change Control
    • Audit Management
    • Supplier Quality Management
    • Training Management
    Tell me more about QualityOne

    About Veeva

    Veeva

    Founded in 2007, Veeva NYSE (VEEV), is a leading global provider of cloud-based software solutions for regulated industries such as consumer goods, chemical, cosmetics, and life sciences.

    Our applications enable manufacturers to realize the benefits of a modern, cloud-based platform to manage the product journey and bring innovative, high-quality products to market faster without compromising industry-specific functionality, quality or regulatory compliance.

    Learn more about Veeva's Solutions

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