Quality and Industry 4.0

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Quality and Industry 4.0
Quality 4.0 comes from the idea that globally the world is in the fourth industrial revolution. The term Industry 4.0 was coined in 2011 at the Hannover Fair. Industry 4.0 is often called the Fourth Industrial Revolution. “By enabling “smart factories”, the fourth industrial revolution creates a world in which virtual and physical systems of manufacturing globally cooperate with each other in a flexible way.” (1) Quality 4.0 represents the quality practices associated with Industry 4.0.

According to article by James Kline, PH.D. July 25, 2020, the expectation is that the Internet of Things will combine with robotics and big data to increase the automation of industrial activities. A 2018 ASQ study noted the following changes Industry 4.0 will bring for example to the manufacturing floor.

  • Integrated cyber-physical interfaces automate working environments.
  • Automated processes deal with end to end systems.
  • Humans serve only in positions where human judgment cannot be automated and human interactions cannot be simulated.
  • Machines learn to learn (artificial intelligence).
Implications for Quality Profession
The shift occurring on the production line, is having a significant impact on the quality profession. One fundamental consequence is that robots will be conducting 100% quality inspections. Except in rare situations, the sampling of products for quality control purposes will not be needed. This will result in the reduction of quality inspectors and the need for certifications like ISO 9001.

The ASQ study emphasizes that the quality profession must move from data analyst to “data wrangler”. This is to be accomplished by engaging with new technologies. Fortunately, quality professionals are well positioned because they have deep skills in several areas Industry 4.0 will emphasize. These are:

  • Systems thinking
  • Data-driven decision making
  • Leadership for organizational learning, and
  • Statistics
Further Quality 4.0 differences from present include:
  • Quality shifts its control-oriented focus from the process operators to the process designers.
  • Machines learn how to self-regulate and manage their own productivity and quality.
  • Human performance is essential; the emphasis shifts from production to system design and integration with the business system.
This transformation has its challenges. For example, as for “leadership for organizational learning”, within an organization a quality professional generally is low on the decision-making ladder. Their leadership impact will therefore be limited. As for “organizational learning”, what it means and how quality professionals are to contribute is not well defined in ASQ’s report. Further, in some cases when quality professionals go outside the bounds of the quality management system, they can be outside their area of expertise. When they step outside their area of expertise, it becomes harder to keep other professionals from encroaching on those areas. As the study found, companies implementing Industry 4.0 will have to provide a number of skill upgrades.

For more information on Quality 4.0, visit the ASQ Website.

Process Owner R&R
To understand the term “process owner”, let’s begin with the definition of a process. A Process is a set of interrelated or interacting activities which transforms inputs into outputs. The inputs of a process are the outputs from other processes. And, processes are planned and carried out under controlled conditions to add value.

A Process Owner is a person who is given the responsibility and authority for managing a particular process. Most organizations find it useful to appoint individual process owners and define their responsibilities as ensuring the implementation, maintenance, and improvement of their specific process and its interactions with other processes.

Process owners take an organization-wide view of their processes. They may not truly “own” the process in that some of the people who are involved in carrying out the process may not report to them. Instead, the owner is responsible for the design of the process, in other words, how it is carried out, how it interacts with other processes, and how it is measured. And, this responsibility is an ongoing task.

Process owners have responsibility for their specific process, end-to-end. However, as stated earlier, this does not mean that all the staff involved in a process actually report to the process owner. Process owners usually have responsibility for most steps in the process and are able to influence other key areas outside their direct organizational control. 

Process owners can use the Plan-Do-Check-Act methodology to improve their processes: 1) planning what to do and how to do it, 2) doing what was planned, 3) checking the results to see if things happened according to plan, and 4) acting to improve the process the next cycle.

In summary, a Process Owner is the person immediately accountable for creating, sustaining, and improving a particular process, as well as, being responsible for the outcomes of the process. 
Analysis and Evaluation Auditing
Analyzing data is an essential activity for improving your system and its processes, as well as, your products and services. Data collection has no purpose if the data isn’t examined, evaluated, analyzed, and converted into proposals for decision making.

The term “analysis” can be defined as the breaking up of something complex into its various simple elements. The reason to separate something into its elements is to determine either their nature (qualitative analysis) or their proportions (quantitative analysis). Therefore, we analyze the data to show the quality management system is effective (achieving planned results) and to spot where improvements can be made. It is not enough to just collect the data, we must analyze it and reach some conclusions.

As a result of the monitoring and measurement activities called for by ISO 9001:2015, 9.1.3, Analysis and Evaluation you will have collected a lot of data, which can be analyzed to indicate trends. Any trends you may find could suggest where there are problems in your quality management system and indicate areas where improvements are needed.

Analysis of data can help to determine the root cause of existing or potential problems, and thereby guide decisions about corrective and preventive actions need for improvement. For an effective evaluation by management of the total performance of an organization, data from all parts of the organization should be integrated and analyzed.

The overall performance should be presented in a format that is suitable for different levels of the organization. The results of this analysis and auditing can be used to determine:

  • Trends; customer satisfaction (and satisfaction of other interested parties)
  • Process effectiveness and efficiency; supplier contribution
  • Success of performance improvement objectives
  • Economics of quality, financial, and market-related performance
  • Performance bench marking; competitiveness
Performance Metrics Mix
Performance metrics are a vital part of managing an organization. Many organizations have a tendency to select metrics by copying what competitor’s measure, what is read in the business press, and what benchmark firms are using.

The best organizational metrics keep the focus on its strategic direction, not the direction in which others are going!

The types of metrics and the right mix of metrics drives effective outcomes.

For example, some metrics should focus on customer needs (externally focused, effectiveness metrics) and some on organizational needs (internally focused, efficiency metrics) so the organization can effectively balance the management of resources used to achieve the market results. An organization with high customer satisfaction and costs that create negative profitability is not going to be a sustainable venture.

Some metrics should be able to evaluate results (outcome or lagging metrics), while others should allow proactive management of the vital factors (process or leading metrics) that create those outcomes. For example, on-time delivery (an outcome) might be significantly impacted by equipment reliability (a leading indicator for delivery performance). However, equipment reliability is an outcome measure for the maintenance management process. As much as possible, metrics should be biased toward business drivers, such as process or leading indicators, instead of outcomes.

Once the desired metrics have been identified, the real work begins. Decisions must be made regarding:

  • Who owns the metric?
  • Where will the data be acquired and how often?
  • How might the raw data be manipulated (normalized) to allow more equivalent comparisons over time?
  • How often should the metrics be reported and analyzed for decision making?
Although it might sound simple, creating operational definitions is an important component of metric details. What is meant by the terms as expressed in mathematical terms (for example, numerator, and denominator and time boundaries)? A company might ask, “What is meant by on-time delivery?” When it is picked up by the carrier or when it arrives at the target location? Clear measurement and accurate definitions are important to an organizations success.
In The News
ISO 9001 User Survey 2020
The committee responsible for the development of the international standard, ISO 9001:2015—”Quality management systems—Requirements,” has announced a user survey to gather information on the value of ISO 9001:2015.

According to a press release from ISO/Technical Committee 176/Subcommittee 2, ISO 9001:2015 is currently undergoing a formal “systematic review” that is due to close on Dec. 2, 2020. Following the review, ISO/TC 176/SC2 will have up to six months in which to decide whether the standard should be “confirmed” (i.e., left unchanged), be revised or amended, or be withdrawn.

The goal is to capture:

• Data on the value to organizations of implementing a quality management system in accordance with the requirements of the current 2015 edition of ISO 9001
• Data on its advantages and disadvantages
• User opinions on how to ensure this standard remains relevant in the future

In addition, ISO/TC 176 has been giving consideration to “future concepts” for quality. SC2 would like to test the acceptability of such concepts with users, for potential inclusion in a future edition of ISO 9001.

The committee invites all categories of users of ISO 9001 from all over the world to participate in a global survey about ISO 9001’s future. For your convenience, the survey has been developed in 13 languages on SurveyMonkey; choose the language that is most convenient for you using the language link in the upper right corner of the survey page. 

Training Courses
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Remote Versus Virtual Audits – We’re conducting Virtual Audits- Are You?  
With the current business environment, Virtual and/or Remote Auditing is currently the norm. “Auditing of a virtual location is sometimes referred to as virtual auditing.” ISO 19011. Remote auditing use techniques such as interactive web-based collaboration, web meetings, teleconferences and/or electronic verification of the client’s processes. Remote audits refer to the use of ICT to gather information, interview an auditee, when “face-to-face” methods are not possible or desired. (ISO 19011)

ISO 9001 Auditing Practices Group Guidance on: REMOTE AUDITS

Best regards,
Walter Tighe and SES Team  

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