Quality Management System Sleep Facts

If your idea of a relaxing bedtime story involves process audits and ISO compliance, you’re in luck. Tonight’s episode meanders through the riveting world of quality management systems—because nothing lulls you to sleep quite like risk-based thinking, internal controls, and continuous improvement cycles.

Ideal for insomnia relief or anyone who finds comfort in bureaucracy.

Transcript

Welcome to the I Can't Sleep podcast,

Where I help you learn a little and sleep a lot.

I'm your host,

Benjamin Boster,

And tonight,

Let's fall asleep learning about quality management systems.

Thank you,

Melissa Peet,

For sponsoring tonight's episode.

This topic is pretty interesting to me,

And I invite you to see if you can make it 10 minutes or longer.

So if you make it to the end of the episode,

Leave a comment or leave a review or something like that and let me know if you made it.

Okay,

Quality management systems.

A quality management system,

Often designated as QMS,

Is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction.

It is aligned with an organization's purpose and strategic direction,

ISO 9001-2015.

It is expressed as the organizational goals and aspirations,

Policies,

Processes,

Documented information,

And resources needed to implement and maintain it.

Early quality management systems emphasized predictable outcomes of an industrial product production line,

Using simple statistics and random sampling.

By the 20th century,

Labor inputs were typically the most costly inputs in most industrialized societies.

So focus shifted to team cooperation and dynamics,

Especially the early signaling of problems via a continual improvement cycle.

In the 21st century,

QMS has tended to converge with sustainability and transparency initiatives,

As both investor and customer satisfaction and perceived quality are increasingly tied to these factors.

Of QMS regimes,

The ISO 9000 family of standards is probably the most widely implemented worldwide.

The ISO 19011 audit regime applies to both and deals with quality and sustainability and their integration.

Other QMS,

E.

G.

Natural step,

Focus on sustainability issues and assume that other quality problems will be reduced as a result of the systematic thinking,

Transparency,

Documentation,

And diagnostic discipline.

The term quality management system and the initialism QMS were invented in 1991 by Ken Croucher,

A British management consultant working on designing and implementing a generic model of QMS within the IT industry.

Elements 1.

Quality objectives 2.

Quality manual 3.

Organizational structure and responsibilities 4.

Data management 5.

Processes,

Including purchasing 6.

Product quality leading to customer satisfaction 7.

Continuous improvement,

Including corrective and preventative action 8.

Quality instrument 9.

Document control 10.

Employee training and management 11.

Supplier quality management Concept of quality historical background The concept of equality as we think of it now first emerged from the industrial revolution.

Previously,

Goods had been made from start to finish by the same person or team of people with hand crafting and tweaking the product to meet quality criteria.

Mass production brought huge teams of people together to work on specific stages of production where one person would not necessarily complete a product from start to finish.

In the late 19th century,

Pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output.

Berland established quality departments to oversee the quality of production and rectifying of errors.

And Ford emphasized standardization of design and component standards to ensure a standard product was produced.

Management of quality was the responsibility of the quality department and was implemented by inspection of product output to catch defects.

Application of statistical control came later as a result of World War production methods which were advanced by the work done of W.

Edwards Deming,

A statistician,

After whom the Deming Prize for Quality is named.

Joseph M.

Juran focused more on managing for quality.

The first edition of Juran's Quality Control Handbook was published in 1951.

He also developed the Juran's Trilogy,

An approach to cross-functional management that is composed of three managerial processes,

Quality planning,

Quality control,

And quality improvement.

These functions all play a vital role when evaluating quality.

Quality as a profession and the managerial process associated with the quality function was introduced during the second half of the 20th century and has evolved since then.

Over this period,

Few other disciplines have seen as many changes as the quality profession.

The quality profession grew from simple control to engineering,

To systems engineering.

Quality control activities were predominant in the 1940s,

1950s,

And 1960s.

The 1970s were an era of quality engineering and the 1990s saw quality systems as an emerging field.

Like medicine,

Accounting,

And engineering,

Quality has achieved status as a recognized profession.

As Lee and Dale,

1998,

State,

There are many organizations that are striving to assess the methods and ways in which their overall productivity,

The quality of their products and services,

And the required operations to achieve them are done.

The two primary state-of-the-art guidelines for medical device manufacturer QMS and related services today are the ISO 13485 standards and the U.

S.

FDA 21 CFR 820 regulations.

The two have a great deal of similarity and many manufacturers adopt QMS that is compliant with both guidelines.

ISO 13485 are harmonized with European Union Regulation 2017-745 as well as the IVD and AIMD directives.

The ISO standard is also incorporated in regulations for other jurisdictions such as Japan,

JPAL,

And Canada,

CMD,

CAS.

Quality system requirements for medical devices have been internationally recognized as a way to assure product safety and efficacy and customer satisfaction since at least 1983 and were instituted as requirements in a final rule published on October 7,

1996.

The U.

S.

Food and Drug Administration,

FDA,

Had documented design defects in medical devices that contributed to recalls from 1983 to 1989 that would have been prevented if quality systems had been in place.

The rule is promulgated at 21 CFR 820.

According to current Good Manufacturing Practice,

GMP,

Medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System QS regulation that are applicable to their specific products and operations in Part 820 of the QS regulation.

As with GMP,

Operating within this flexibility,

It is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective,

And to establish methods and procedures to design,

Produce,

And distribute devices that meet the quality system requirements.

The FDA has identified in the QS regulation the seven essential subsystems of a quality system.

These subsystems include management controls,

Design controls,

Production and process controls,

Corrective and preventative actions,

Material controls,

Records,

Documents,

And change controls,

Facilities,

And equipment controls,

All overseen by management and quality audits.

Because the QS regulation covers a broad spectrum of devices and production processes,

It allows some leeway in the details of quality system elements.

It is left to manufacturers to determine the necessity for or extent of some quality elements and to develop and implement procedures tailored to their particular processes and devices.

For example,

If it is impossible to mix up labels at a manufacturer because there is only one label to each product,

Then there is no necessity for the manufacturer to comply with all of the GMP requirements under device labeling.

Drug manufacturers are regulated under a different section of the Code of Federal Regulations.

The International Organization for Standardizations,

ISO 9001-2015 series describes standards for a QMS addressing the principles and processes surrounding the design,

Development,

And delivery of a general product or service.

Organizations can participate in a continuing certification process to ISO 9001-2015 to demonstrate their compliance with the standard,

Which includes a requirement for continual,

I.

E.

Planned,

Improvement of the QMS,

As well as more foundational QMS components such as failure mode and effects analysis,

FMEA.

ISO 9001-2005 provides information on the fundamentals and vocabulary used in quality management systems.

ISO 9004-2009 provides guidance on a quality management approach for the sustained success of an organization.

Neither of these standards can be used for certification purposes as they provide guidance,

Not requirements.

The Baldrige Performance Excellence Program educates organizations in improving their performance and administers the Malcolm Baldrige National Quality Award.

The Baldrige Award recognizes U.

S.

Organizations for performance excellence based on the Baldrige criteria for performance excellence.

The criteria address critical aspects of management that contribute to performance excellence,

Leadership,

Strategy,

Customers,

Measurement,

Analysis,

And knowledge management,

Workforce,

Operations,

And results.

The European Foundation for Quality Management's EFQM Excellence Model supports an award scheme similar to the Baldrige Award for European companies.

In Canada,

The National Quality Institute presents the Canada Awards for Excellence on an annual basis to organizations that have displayed outstanding performance in the areas of quality and workplace wellness,

And have met the Institute's criteria with documented overall achievements and results.

The European Quality and Social Service,

EQUASS,

Is a sector-specific quality system designed for the social services sector and addresses quality principles that are specific to service delivery to vulnerable groups,

Such as empowerment,

Rights,

And person-centeredness.

The Alliance for Performance Excellence is a network of state and local organizations that use the Baldrige criteria for performance excellence at the grassroots level to improve the performance of local organizations and economies.

Browsers can find Alliance members in their state and get the latest news and events from the Baldrige community.

A QMS process is an element of an organizational QMS.

The ISO 9001 standard requires organizations seeking compliance or certification to define the processes which form the QMS and the sequence of interaction of these processes.

Butterworth,

Heinemann,

And other publishers have offered several books which provide step-by-step guides to those seeking the quality certifications of their products.

Examples of such processes include comply with specific requirements,

E.

G.

Statistical process control and measurement systems analysis.

Calibrations,

Corrective and preventative action,

Internal audit,

Order processes,

Product,

Service,

Process measurements to identification,

Labeling,

And control of non-conforming products to prevent its inadvertent use,

Delivery,

Or processing.

Production plans.

Purchasing and related processes such as supplier selection and monitoring.

ISO 9001 requires that the performance of these processes be measured,

Analyzed,

And continually improved,

And the results of this form an input into the management review process.

Quality management software offers the techniques,

Processes,

Structure,

And resources needed to simplify manufacturing and ERP activities while handling quality concerns efficiently and cost-effectively.

Helps manufacturers to monitor,

Control,

And document quality processes electronically to guarantee that goods are made with intolerance,

Meet all necessary requirements,

And are defect-free.

Quality management software is often used in the manufacturing industry to identify potential issues before they occur.

Some benefits of quality management software include real-time data monitoring,

Issue prevention,

Risk management,

Increased efficiency and productivity,

Process consistency,

Increased employee participation.

Quality management software can be integrated with manufacturing execution systems,

MES.

An MES is a complete dynamic software system for monitoring,

Tracking,

Documenting,

And controlling the manufacturing process from raw materials to final products.

When combined with QMS,

These systems ensure compliance,

Enable quality programs,

Eliminate waste,

Less product recalls,

Lower per-product cost,

Higher product quality,

Product tracking,

Real-time information for increase in quality control,

Realistic production schedules,

Up-to-date inventory.

Quality management software focuses on four main elements.

One,

Document management.

Quality management software enables companies to manage all product and quality records and documents,

Including product specifications,

Work instructions,

Standard operating procedures,

SOPs,

Quality policies,

And training records,

Among other things,

To fulfill highly regulated requirements.

Quality management software centralizes the storage of these documents.

Two,

Regulatory compliance.

To decrease compliance risks,

Quality management software is used within companies to make sure they comply with ISO,

OSHA,

FDA,

And other industry norms and requirements.

The software makes closed-loop corrective and preventative action procedures countable.

Three,

Feedback loops.

Quality management software permits staff to submit feedback or recommendations through centralized software.

In turn,

This way,

Managers gather insights from the shop floor,

Creating a feedback loop.

Four,

Training and skill management.

To maintain product quality,

Quality management software can provide a fixed system through which employees and staff can be trained.

This fixed system provides more clarity in the different tracking processes of the company and simplifies the tracking of different skill levels of employees.

Most quality management software are cloud-based and offer software as a service.

A business process,

Business method,

Or business function is a collection of related structured activities or tasks performed by people or equipment in which a specific sequence produces a service or product that serves a particular business goal for a particular customer or customers.

Business processes occur at all organizational levels and may or may not be visible to the customers.

A business process may often be visualized,

Modeled as a flowchart of a sequence of activities with interleaving decision points or as a process matrix of a sequence of activities with relevance rules based on data in the process.

The benefits of using business processes include improved customer satisfaction and improved agility for reacting to rapid market change.

Process-oriented organizations break down the barriers of structural departments and try to avoid functional silos.

A business process begins with a mission objective,

An external event,

And ends with achievement of the business objective of providing a result that provides customer value.

Additionally,

A process may be divided into sub-processes,

Process decomposition,

The particular inner functions of the process.

Business processes may also have a process owner,

A responsible party for ensuring the process runs smoothly from start to finish.

Broadly speaking,

Business processes can be organized into three types,

According to von Rosing et al.

1.

Operational processes,

Which constitute the core business and create the primary value stream,

E.

G.

Taking orders from customers,

Opening an account,

And manufacturing a component.

2.

Management processes,

The processes that oversee operational processes,

Including corporate governance,

Budgetary oversight,

And employee oversight.

3.

Supporting processes,

Which support the core operational processes,

E.

G.

Accounting,

Recruitment,

Call center,

Technical support,

And safety training.

There are other definitions of the classification of processes proposed by 1.

Strategic processes,

Which are managerial,

Directive,

Or steering processes.

Management has an important role in each of these.

This type of process is related to strategic planning,

Partnerships,

Etc.

2.

Operational processes,

Which are business processes,

Are of a productive or missional nature.

These processes generate a product or service to be delivered to customers.

These are considered to be unique or specific to each organization.

3.

Support processes,

Which are auxiliary in nature,

Support for operational and strategic processes.

These are responsible for providing resources and are presented in most organizations.

4.

A business,

Made up of many processes,

May be decomposed into various sub-processes,

Each of which have their own peculiar aspects,

But also contribute to achieving the objectives of the business.

The business review analyzes processes that usually include the mapping or modeling of processes and sub-processes down to a group of activities at different levels.

Processes can be modeled using a large number of methods and techniques.

For instance,

The business process modeling notation is a business process modeling technique that can be used for drawing business processes in a visualized workflow.

While decomposing processes into process classifications,

Categories can be helpful,

But care must be taken in doing so,

As there may be crossover.

Alas,

All processes are part of a largely unified customer-focused result,

One of customer value creation.

This goal is expedited with business process management.

Which aims to analyze,

Improve,

And enact business processes.

An important early 1776 description of processes was that of economist Adam Smith in his famous example of a pin factory.

Inspired by an article in Diderot's encyclopedia,

Smith describes the production of a pin in the following way.

One man draws out the wire.

Another straights it.

A third cuts it.

A fourth points it.

A fifth grinds it at the top for receiving the head.

To make the head requires two or three distinct operations.

To put it on is a peculiar business.

To widen the pin is another.

And the important business of making a pin is,

In this manner,

Divided into about 18 distinct operations,

Which in some manufactories are all performed by distinct hands,

Though in others the same man will sometimes perform two or three of them.

Smith also first recognized how output could be increased through the use of labor division.

Previously,

In a society where production was dominated by handcrafted goods,

One man would perform all the activities required during the production process.

While Smith described how the work was divided into a set of simple tasks,

Which would be performed by specialized workers.

The result of labor division in Smith's example resulted in productivity increasing by 24,

000%,

I.

E.

,

That same number of workers would make 240 times as many pins as they had been producing before the introduction of labor division.

Smith did not advocate labor division at any price or per se.

The appropriate level of task division was defined through experimental design of the production process.

In contrast to Smith's view,

Which was limited to the same functional domain and comprised activities that are in direct sequence in a manufacturing process,

Today's process concept includes cross-functionality as an important characteristic.

Following his ideas,

The division of labor was adopted widely,

While the integration of tasks into a functional or cross-functional process was not considered as an alternative option until much later.

American engineer Frederick Winslow Taylor greatly influenced and improved the quality of industrial processes in the early 20th century.

His principles of scientific management focused on standardization of processes,

Systematic training,

And clearly defining the roles of management and employees.

His methods were widely adopted in the United States,

Russia,

And parts of Europe,

And led to further developments such as time and motion study and visual task optimization techniques such as Gantt charts.

In the latter part of the 20th century,

Management guru Peter Drucker focused much of his work on the simplification and decentralization of processes,

Which led to the concept of outsourcing.

He also coins a concept of the knowledge worker as differentiated from manual workers,

And how knowledge management would become part of an entity's processes.

Davenport,

1993,

Defines a business process as a structured,

Measured set of activities designed to produce a specific output for a particular customer or market.

It implies a strong emphasis on how work is done within an organization,

In contrast to a product focuses emphasis on what.

A process is thus a specific ordering of work activities across time and space,

With a beginning and an end,

And clearly defined inputs and outputs,

A structure for action.

Taking a process approach implies adopting the customer's point of view.

Processes are the structure by which an organization does what is necessary to produce value for its customers.

This definition contains certain characteristics that a process must possess.

These characteristics are achieved by focusing on the business logic of the process,

How work is done,

Instead of taking a product perspective,

What is done.

Following Davenport's definition of a process,

We can conclude that a process must have clearly defined boundaries,

Input and output,

Consist of smaller parts and activities,

Which are ordered in time and space,

That there must be a receiver of the process outcome,

The customer,

And that the transformation taking place within the process must add customer value.

Reviews

Interesting subject (or maybe I’m a weirdo) but I still fell asleep so success at least! 😁😁😁

Well, I didn’t make it even 10 minutes. But it made me think of my company’s QC processes. Very in-depth. We would not only check our own work but we’d do it for others. It was vital! We all can make mistakes: typos or deeper errors. Anyway, thanks, Ben for this reading. Since I didn’t get far I can listen again!!

Keep them coming! Even the excitement of quality management systems is no match for your soothing, monotone delivery.