By Tom Taormina
Each article in this series (part one here, part two here, part three here, part four here and part five 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 8 of the standard, “Operation.”
Clause 8 contains the requirements for planning, designing, and bringing to fruition your products or services. The processes within this clause must be robustly implemented to achieve business excellence. They must also be continually scrutinized for foreseeable risk.
8.1—Operational planning and control
8.1 and excellence
The “plan” is a series of interrelated process, each with acceptance criteria, and each with metrics that tie to the organization’s key objectives and key process indicators. Or, at least that has been my interpretation while leading scores of implementations.
During my 14 years at Mission Control in Houston, I often pondered, “Who has the master plan for Project Apollo?” Was there a giant room full of program evaluation and review technique (PERT) charts subordinate to a master PERT chart? There had to have been a top-level plan that covered everything from the vehicle, booster, subsystems, and the Manned Spaceflight Network.
As the prime contractor for Mission Control, we had a detailed contract with NASA that started with the blueprint for the building and contained the high-level requirements and milestones to start controlling Gemini missions on a specific date.
We had an engineering department that turned the requirements into interrelated subsystems and individual pieces of hardware. We did have a room full of drafting tables and schedulers tending to their PERT charts. We had a manufacturing facility that turned the engineering drawings into hardware.
We had a quality control group that made sure the hardware was compliant with the drawings. Essentially, we planned to land men on the moon, and we executed the plan. Or as I put it, we made up our minds to win the space race and just did it.
Clause 8 does not imply planning in the context of Project Apollo. Unfortunately, I do not believe I have ever seen an organization with a “master plan” for implementing and controlling processes. The clause says, “The output of this planning shall be suitable for the organization’s operations.”
Do your senior leaders have the metrics to determine if the planning is suitable? What are they planning for? Planning for business excellence really does not need the level of planning that we did for Project Apollo, but organizations without the vision, mission, and values we had will never achieve their greatest potential.
8.1 and risk
The risk was clear for Project Apollo. We built process controls and redundancies into every process that would ensure we did not kill three astronauts in space. Operational planning must include specific activities that examine processes for foreseeable risk.
What are your goals? Planning to avoid risk or just to think about it?
8.2.1—Requirements for products and services—Customer communication
8.2.1 and excellence
Are your customers referrals or constantly complaining? Do you send out requests for scorecards, or do you have genuine dialogue with your customers?
Excellence in customer satisfaction is maintaining an active “voice of the customer” function within the organization. This is not the sales force taking clients out to lunch or playing golf with them.
If you build products or provide services to specifications, you must be a frequent visitor at your customer’s site and inculcate in your organization exactly how the product or service will be used, what their risk priorities are, and how you contribute to their excellence. I suggest that you request an invitation to design-review meetings, and (with the proper disclosure agreements) sit in on their marketing-strategy sessions and product rollout planning so that you can be proactive about your customer’s requirements.
If you sell products of your design, occasional feedback from the sales force is not going to achieve excellence for your organization. One of my clients makes roofing material. Their sales force, manufacturing, and QA folks regularly put on rubber boots, show up at a job site on a hot August day, and discover firsthand the issues that the installers have with their products and how they can make them better.
Feedback of any kind from a customer is like being handed a gold bar. It is priceless if it is used for continual improvement in your organization.
8.2.1 and risk
The same level of communication discussed above is your best input for risk and liability avoidance. Intimate knowledge of how your product or service is used and misused is another windfall of opportunity to define foreseeable risk and how to avoid it.
A company that makes battery chargers was named as defendants in a case where a young boy was electrocuted using one of its products. The “hot” wire of the AC main power inside the unit had abraded and had come in contact with the metal cabinet.
The company’s defense was that the house was old and did not have grounded outlets. The residents routinely cut the safety ground pin off extension cords, and the boy was barefoot on wet ground. If the house were properly wired, a breaker would have tripped before the boy was exposed to lethal voltages, or so the company alleged. If they had done regular investigations of how consumers used their products, they would have added a few zip ties to immobilize the internal wiring and made the handle out of plastic instead of metal. Instead, they paid millions for the death of the child. You must anticipate stupidity.
8.2.2—Determining the requirements for products and services
8.2.2 and excellence
Of the broad requirements of this subclause, ensuring that you can meet your claims for products and services is an opportunity for excellence. How do you ensure you are meeting the claims you make through advertising and specifications? Verification and validation are seldom comprehensive enough to continually substantiate your claims.
One client I worked with manufactured microwave data radios. Its quality policy was “XYZ manufactures the best microwave data radios in the world.” During my consulting assignment, we dissected that statement into its component parts and created a tiger team to define the policy and continually measure it.
First the policy states that the company “manufactures” its product. That statement was based on studying best-in-class manufacturing operations, learning from them, and concluding the company would always manufacture its products in-house.
The term “best” was scrutinized by benchmarking the company’s products against similar products manufactured around the world. The engineering, quality, and field operations validated that its products continually met its own specifications, were compliant with FCC and other regulatory requirements, and performed more robustly than its competition.
“Microwave” defined that the company would not build products in the high frequency or other of radio spectrums. “Data” set the benchmark for not entering the voice or telecom markets. “In the world” defined its market and ensured that it sold the best products available globally.
Interpreting 8.2.2 as this company did ensures not only compliance but ongoing excellence.
8.2.2 and risk
Published claims, in any form, are more than promises to your clients. They are the basis for sheltering your organization from civil liability. Absent empirical data for compliance to your claims, a plaintiff’s attorney can destroy any defense you might have of appropriate standard of care.
When I start a new case, I immediately go to the defendant’s website and look for claims of product performance, adherence to regulatory requirements, and statements that must be backed by data for them to be true. Many times, I have found that the sales group that designed the website embellished claims that were misleading or damning. Often, they use ISO 9001 certification out of context as a guarantee of quality.
Years ago, I found the supplier requirements document on the website of one of the largest retailers in the world. I used it liberally in my expert report. It was removed from the website and was even purged from the Wayback Machine website.
8.2.3—Review of the requirements for products and services
8.2.3 and excellence
Contract review is too often a mechanical process that results in either an agreement to supply products and services to the organization’s specification, or a formal contract to build products or provide services based on specifications and drawings.
To move from conformity to excellence, reexamine every nuance of your sales and contract review processes. Remove ambiguities and embellishments in your spec sheets and advertising media. Replace them with definitive factual statements that give the customer the confidence that you have made every attempt to ensure that what the customer wants, they get.
From orders to specifications and drawings, ensure the customer understands your diligence for meeting every aspect of the requirements. Make them aware of your QMS, testing, and validation processes.
8.2.3 and risk
Whether your products or services are sold by a retailer at a point-of-sale terminal or you have formal contractual relationships with your customer, every transaction is an opportunity for product liability or organizational risk litigation.
Your contract review process must be as diligently executed as if you were preparing to defend yourself in court.
In part five of this series, covering Clause 7, I related a case history of a Chinese manufacturer of power supplies being sued by an American company. The manufacturer repeatedly warned the customer that if it paired its power supply with the peripheral connectors the customer manufactured, the quality and reliability of the final product would be unacceptable. That led to a recall of 500,000 units and the lawsuit.
Every day at lunch during my visit to the factory, senior management always asked the question, “What did we do wrong?” My answer was always the same: “You should not have signed the contract.”
8.2.4—Changes to requirements for products and services
8.2.4 and excellence
Changing contracts or requirements is more than adequate revision control. For changes to drive excellence, you must map every nuance of how the changes can enhance the products or services. Change can be value-added if they enhance the customer experience. It is also an opportunity to review the original documents, specs, and contracts for improvement opportunities.
8.2.4 and risk
Conversely, changes are the breeding ground for unforeseen negative consequences. As my software colleagues tell me, it is inevitable that changing one line of code in a program almost always causes a bug in another part of a program.
Whether changing specifications or contracts, a change-control committee should put multiple sets of eyes on the changes and do a root cause analysis about the potential outcomes of proposed changes.
8.3—Design and development of products and services
The requirements of 8.3 are far too complex to deal with in this article. Design and development done well yields excellent quality and reliability. Done incompletely or badly, you are ensured of designing foreseeable risk into your products and services.
When I facilitate an implementation that includes design and development, I recommend copying each subclause verbatim into five standalone operational procedures. Involving sales and production, I turn each requirement into an opportunity for excellence. I do a foreseeable risk analysis on the response to each requirement. I also test the operational procedures for how they will become part of the organization’s culture, not simply a compliance requirement.
8.4—Control of externally provided processes, products, and services
Again, we cannot cover the nuances of supply chain management adequately in this article. It has become a science all to itself.
I was part of a team that rewrote Dell Computer’s supplier quality manual. It was a six-month process involving dozens of contributors, including input from suppliers. Dell management invests heavily in the risks and rewards of exceptionally effective supply chain management.
I have an article posted on Advisera’s ISO 9001 blog, “How to Create Beneficial Supplier Partnerships in ISO 9001,” that will give you some ideas to help your efforts.
I have another article on the same blog, “Understanding Outsourcing According to ISO 9001: A Case Study,” that deals with one of the most misunderstood requirements of the standard, outsourcing.
8.5—Production and service provision
The third in the trifecta of most critical clauses in the standard is executing the manufacture or service implementation. This is the epitome of the process model implementation and defines the interaction of all the processes within the workflow.
A comprehensive audit of your production and service provisions, focusing on turning each process into a profit center while identifying all foreseeable risk, is the most effective path to business excellence and avoiding risk.
We will learn how to achieve these goals when we discuss Clause 9.2—Internal Audit, in the next installment of this series.
8.6—Release of products and services
8.6 and excellence
Releasing your products and services into the commercial stream is the final step of delivering excellence. Each organization has its processes that ensure defects do not move from workstation to workstation. You also have a process for ensuring that all requirements are met before the product goes out the door.
If your culture and methods are implemented for ensuring conformance, you will likely not reach excellence. On the other hand, if you embrace the philosophy of no defective products reaching a customer, the entire organization must adopt that culture and create an enterprisewide system of verification.
When we led the ISO 9001:2000 transition at Dell Computer’s Asset Recovery Business, we implemented “a web-based business management system to map business processes, communicate business initiatives across the company, cross-train the employee, and report daily progress against business metrics.” That sentence was extracted from a report by the dVP, a year following the implementation of the enterprisewide business management system. Defects never moved from one work center to the next. There was an extensive burn-in test, and finally, out-of-box audits (OBA) on every batch. Again, from that report: “reduced OBA/OBE defect rate from 28 percent to 7.3 percent.”
I have been out of touch with that division for 20 years, and there have been many management changes at Dell, but they were on the path to no defect ever reaching a customer.
8.6 and risk
Ensuring your products and services are defect-free at time of delivery is the last tollgate of foreseeable risk. Again, there are many opportunities to introduce risk into the processes, but avoiding those risks is the most effective method for avoiding customer complaints and legal action.
8.7—Control of nonconforming outputs
8.7 and excellence
Nonconformance reports, segregation, material review boards, and corrective action are integral to most any ISO 9001-based organization. Subclause 8.7 deals with the mechanics of handling nonconformities. Business excellence is achieved by avoiding defects.
8.7 and risk
Alarm bells go off in my head when I am auditing a company that has a withhold cage full of defective products awaiting disposition. Organizations that have daily material review board meetings signal a cultural acceptance that defects are inevitable. Dispositions of “repair and reinspect” are particularly dangerous to risk avoidance.
One organization had an automated machining system that output the product onto a conveyor belt. When runs were unattended at night, on any given morning, there would be castings laying all over the floor. Inspectors and material review engineers had nearly a full-time job inspecting and dispositioning the castings. This went on for weeks until they gave up on the unattended operation.
If your organization has any more than a handful of in-process nonconformities, defects will inevitably reach a customer.
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.
This article first appeared on the Quality Digest website and is published here with permission.