By Tom Taormina
Each article in this series (part one here, part two here, part three here and part four here) presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall business management. In this article we look at the clauses and subclauses of Section 7 of the standard.
Clause 7 is an interesting montage of people, infrastructure, environmental issues, metrology, knowledge, competence, awareness, communications, and documentation. There is no cohesive theme as there is in Clause 8, “Operation.” So we will look at one subclause at a time.
7.1.1 General resources
7.1.1 and excellence. It is an oversimplification to state that the organization will provide the resources to maintain and continually improve the quality management system. Clauses 4.3, “Determining the scope of the quality management system,” and 4.4, “Quality management system and its processes” both require that adequate resources be available.
Clause 7.1.1 is an appropriate place to define the organization’s culture and its commitment to living the quality policy. The quality policy should more appropriately be a subset of the vision, mission, and values of senior management. Without that commitment, merely providing resources is a plan for mediocrity.
7.1.1 and risk. Risk exposure is directly the outcome of how well we determine the capabilities of internal and external resources. To target the elimination of risk, the competence, awareness, and training programs must focus on risk avoidance. For external sources, the supply chain management system needs to continually evaluate the risk of products and services. One foreseeable risk is that suppliers are in a constant state of flux, and without continual monitoring, quality and reliability can change from one shipment to the next.
7.1.2 and excellence. The differences between greatness, mediocrity, and liability is directly a function of the people and their commitment to the quality policy. I recently visited a contract manufacturing company that produced high-volume electronics components and assemblies. Before the 2008 financial crash, it had more than 100 employees. Today it has 15 and produces a higher volume, at better quality, and enjoys excellent customer loyalty. The owner discovered that training and creating a healthy work environment was the key to excellence. The culture was one of teamwork and cooperation. I think any one of the employees could have given the plant tour, and understood and could explain the company’s vision, mission, and values. Too many of the cultures of other companies I have seen could be summarized as “quality is just a word we use.”
7.1.2 and risk. People make up most of the risk potential in any organization. Virtually every product liability case I work on is the result of unintentional negligence resulting in one or more catastrophic outcomes. When people are unaware of foreseeable risk and how to avoid it, the organization is continually in a state of potential liability.
7.1.3 and excellence. The infrastructure and work environment directly affect the quality and reliability of your products and services. Again, senior management creates the culture that encourages excellence or creates mediocrity and risk. I did three consulting assignments at Dell Computer. One day I was in the break room, and a janitor with a mop and bucket was sitting in front of one of the many computers. I asked him what he was doing. He said he was checking his stock options. He said he would be retiring with a very lucrative portfolio. I asked how his work affected the value of his stock. He said that if he did not keep the facility spotlessly clean and free from hazards, the overall value of the company would suffer.
7.1.3 and risk. Creating a productive and safe infrastructure is a major factor in risk avoidance. I worked with a company that made wooden windows and doors. One of my first projects was to create a process improvement team. The environment was full of hazards from wood scraps, glass, and dust. There was no order to tool maintenance and storage. The company’s scrap and rework rates were abhorrent. As we implemented the quality management system, we rebuilt the infrastructure and made it safer and more functional. The rework and scrap rate dropped precipitously. The injury rate also dropped as the workers discovered how to avoid risk.
7.1.4 Environment for the operation of processes
7.1.4 and excellence. Reflecting on the hundreds of implementations and audits I have done, the tenets of 7.1.4 were never a factor before the 2015 revision, and I am curious about the various ways internal and external auditors assess these requirements. They appear to need the skills of a human-factors expert and process engineer. The same formula for achieving excellence is explained in 7.1.3.
7.1.4 and risk. What is described in 7.1.4 directly correlates to management commitment and creating a healthy and safe work environment. Identifying foreseeable risk and implementing a culture of risk avoidance should be key elements of 7.1.4.
18.104.22.168 Monitoring and measuring resources—general
22.214.171.124 and excellence. This requirement means establishing a viable metrology program commensurate with the products being manufactured. As with many other clauses, the difference between mediocrity and excellence is that for the latter, the culture of those responsible is one of zero defects ever reaching a customer.
126.96.36.199 and risk. Again, the culture of companies that perform conformance verification determines foreseeable risk. When sampling programs in verification, they should be evaluated for how successfully they contribute to risk avoidance.
7.1.6 Organizational knowledge
7.1.6 and excellence. Once again 7.1 shifts gears in its requirements to the business culture. The tenets of 7.1.6 should be the call to action for senior management to define their company’s culture and assess how each of these requirements can contribute to business excellence.
Several years ago, I visited perhaps the world’s largest manufacturer of OEM computer power supplies near Shanghai. Power supplies were built on a multistory assembly line. The facility was immaculate. The bottom floor had a suite of classrooms that were full all the time. Also on the first floor was one of the largest test facilities I have ever seen. It was used for physical and electrical destructive testing, and design verification and validation.
Each stage of assembly had 100-percent inspection and testing as appropriate. Anyone on the assembly line could push a button and stop the line if he found a defect. The company produced thousands of units a day. Every lot had a sample sent to destructive testing. The final step was an out-of-box audit.
The plant manager and his senior staff had created this amazing environment of thousands of workers being emotionally committed to their jobs and to zero defects. I brought the plant manager a gift of a deputy sheriff badge from historic Virginia City, Nevada. He wore it proudly the time I was there, and you could see that the workers had great respect for him because they would point at the badge and he would get a giant Cheshire grin on his face.
That is my most profoundly successful example of business excellence.
7.1.6 and risk. Organizational knowledge is key to risk avoidance. The more workers know about the products and services and how they are used, the more likely they are to identify foreseeable risk.
I was in Shanghai because a company had been sued. It manufactured a power supply, and its customer, in the United States, added the power supply’s final configuration and other components. The customer had 500,000 units recalled for safety issues. That company blamed my client.
When my client got the original order, it requested sample final assemblies for testing. It found serious design defects and reported them to the customer. I still have a copy of the email that says, “We understand your concern, but go ahead and build them.”
Every day I had lunch with the senior staff. Ultimately, the general manager and QA manager asked, “What did we do wrong?” My answer was simple. “You tried too hard to accommodate the customer and should have refused the order,” I told them. They now understand foreseeable risk.
Your senior staff needs to create a culture of “what could possibly go wrong” and inculcate it into the workforce.
7.2 and excellence. Determining competence is one of the greatest challenges in running a successful organization. During the last decade, many manufacturers have transitioned from craftsmanship and personal accountability to a constantly changing workforce where too many are working to pay for their toys and outside activities.
The first step to excellence in competence is developing the standards for each position. Get rid of job descriptions that include “and all other duties as assigned” and replace them with roles and responsibilities that have process step descriptions and the expected outcome of each step.
I suggest that the metrics for determining competence be thorough and consistent, and each person be reviewed continually, not at her annual review.
The most dramatic tool for excellence in competence is a pay system that is based on learning new skills and includes risk for making mistakes and rewards for continual improvement.
7.2 and risk. Certified, competent workers are the first line of defense against risk and liability.
I just finished working on a case where a high-pressure hose carrying liquid propane burst, causing extensive fire damage and multiple injuries.
The person who assembled the hose was the lead internal auditor, the most senior assembler, and helped write the work instructions for the assembly process. After much research and deposition transcripts, it became obvious that “some defects were inevitable” in this company’s manufacturing processes.
In that culture, all the trappings of a viable quality management system were there, but because occasional defects were acceptable, the company would always have them.
I call that system a façade of competence.
7.3 and excellence. In the example of the Chinese power-supply manufacturer, the classrooms were not just to teach new skills. Each session emphasized the effect that individuals’ work can have on the required successful outcome, and also how it can affect the end user.
The walls of the facility were covered with graphic reminders of acceptable and unacceptable activities and there were also notices about safety and respectfulness.
7.3 and risk. One of the keys of effective awareness is understanding the risk of noncompliance.
One of the more sobering cases I worked involved the failure of an electrical outlet that caused a house fire and the demise of an entire family.
The electrical products had been proudly manufactured in the United States for decades. The company’s informal quality policy was, “I would be comfortable installing our products in my grandmother’s house.”
A holding company bought the company and moved production offshore. The new company essentially abandoned its quality management system. To me, one of the most striking revelations was that workers had no concept of what they were building or how it was used.
What is scarier is that several of us bought the same outlet in several states, and one out of five had manufacturing defects.
7.4 and excellence. There is an old 10cc song that includes the phrase, “Communication is the problem to the answer.” I challenge nearly every client I work with to describe the intent of that riddle.
For years, we have taught the process of genuine dialogue at every level. Of course, it starts with senior management. They typically do a lot of talking but little effective communication. We touched on this in the third article about leadership and Clause 5.
This topic is covered in detail in Leadership, Power, and Consequences (Morgan James Publishing, 2014), written by one of my associates, Sy Ogulnick. For senior management who want to become true leaders, they need to understand the consequences of their power.
The tenets of genuine dialogue are:
- Being present. Giving your full attention to the topic under discussion
- Giving respect. Respecting those with whom you are communicating
- Confirmation. Getting feedback to make sure the others understood your point
- Candor. Being honest and forthright
7.4 and risk. Miscommunication is probably the greatest cause of problems in your company and in the world in general. People hear what you are saying through the filters of their own paradigms, and what they do as a result can be ineffective to catastrophic.
7.5.1 Documented information—general
7.5.1 and excellence. Again, Clause 7 makes a dramatic segue from interpersonal skills and leadership to documentation. The first requirement is to ensure documentation required by the standard is created. This is a compliance issue.
The second is to create documentation that gives clear and concise direction for the processes and the competence level of the user. Well-documented processes and specifications are a key to organizational excellence.
7.5.1 and risk. Poor documentation is a direct contributor to risk. A terrible example is a well-known company outsourcing process to an offshore manufacturer. They had been building their product for years, mostly in-house. The fabrication drawings in this case had incomplete requirements and notes that were common knowledge within the company but caused the contract manufacturer to make assumptions that turned out to be critical to safety, leading to catastrophic personal injury.
7.5.2 Creating and updating
7.5.2 and excellence. We are fortunate to have all but driven paper documentation into extinction. There is excellent software for creating, reviewing, and approving documents, including identification and revision control. The path to excellence is ensuring the efficacy and appropriateness of the content.
One trick I use for excellence in document control is that every process document I create has a computer-generated date and time stamp applied when it is printed, and the phrase, “This is an uncontrolled reference document and it expires in 24 hours” appears on every printout.
7.5.2 and risk. Creating any type of documentation, specification, and drawing requires competent authors, thorough reviewers, and sign-off by appropriate authorities. The example in 7.5.1 with a poorly created drawing that went through approval and sign off without detecting incomplete information is a foreseeable risk.
When I see a document at Revision Q or a drawing at Revision AA or software at Revision 2.0.356, an alarm bell goes off signaling that revision control and content effectiveness are subject to question and foreseeable risk.
188.8.131.52 Control of documented information
184.108.40.206 and excellence. Again, there is effective software available for document control that can ensure that documents are well protected. Servers can be programmed to have only the latest revisions available to those who have the need to know. Another tool for excellence is to have the documentation hyperlinked to subordinate documentation to prevent data-entry errors.
220.127.116.11 and risk. For many organizations, document control is an afterthought or an annoyance. Your documentation is your intellectual property, and lack of control can be risky and costly.
18.104.22.168 Distribution, storage, and retention
22.214.171.124 and excellence. Fortunately, the days of having to manually distribute paper documents, maintain file cabinets full of drawings, and having an attic full of bankers’ boxes of old documents are mostly behind us. Create all documents on a secure server. Make liberal use of scanning records, and then destroy or archive any paper records. Maintain the integrity and access to electronic documents.
126.96.36.199 and risk. How companies control their documents can have dire consequences in litigation. Critical documentation that has been lost, destroyed, or altered can be grounds to prove organizational negligence. By the way, emails and texts are discoverable documents in litigation. I have seen many email trails that prove liability and negligence.
About the author
Tom Taormina, CMC, CMQ/OE, is a subject matter expert in the ISO 9000 series of standards. He has written 10 books on the beneficial use of the standards. He has worked with more than 700 companies and was one of the first quality control engineers at NASA’s Mission Control Center during Projects Gemini and Apollo. He is also an expert witness in products liability and organizational negligence.