Using Audit Results to Drive Improvement

Audit results are an invaluable source of process improvement opportunities and generally uncover two different categories of intelligence: 1. People not doing things they should, and 2. People doing things they shouldn’t.

People not doing things they should

This is the case where the current procedures, work instructions and other formal approved documents reflect best practices but are not being followed. There are a lot of possible causes for this common situation, but the most likely one is that the organization lacks a comprehensive training program.

People doing things they shouldn’t

This is the case where the current procedures, work instructions and other formal approved documents are being followed, but they do not reflect best practices. Again, many potential reasons, however the overwhelming cause that I find is that the department employees (the real process experts) were not actively engaged in developing the processes. The collateral benefits of this process development method are that the employee ownership of how things are done tends to lead to self-imposed compliance.

The bottom-line is that both of these situations provide low-hanging process improvement fruit that are easy to fix and directly improve efficiency, quality and profits.

Developing a robust internal auditing system is one of the best ways to maintain a consistent, effective quality system and avoid undesirable findings during an external (customer or ISO) audit. But the greatest value to the organization is when internal audits are used as a continuous improvement tool.

Lead Auditor
The process begins with the person who has functional responsibility for the internal auditing process, typically the quality manager or ISO representative. As the leader and owner of this program, there are two imperative disciplines that this person should receive formal training in. The first is ISO Lead-Assessor training from an accredited outside third-party training firm. The second is “Train the Trainer” instruction. Frequently the owner of the auditing program will be the one training the audit staff. And, as with all training, records of this training should become a permanent part of this person’s training file.

Audit Schedule
The next step is to develop a comprehensive audit schedule. Each functional area and major business system should be included in the audit schedule. Most accrediting bodies (Registrars) have a requirement that the entire QMS must be audited at least annually, so the frequency from a high level is already defined. But when adding in all of the subordinate procedures, work instructions, etc. for all of the manufacturing functional areas and support departments, the amount of processes that need to be audited can become daunting. This is where an Audit Schedule can be invaluable. Breaking down the audits into manageable monthly or quarterly buckets spread out with a number of internal auditors minimizes the time constraint and maximizes the opportunity to stay on schedule.

Audit Plan
One of the best ways to assure consistency with your internal audits is to use a standard checklist that covers the exact QMS requirements (ISO 9001, ISO 13485, AS 9100, etc.) The QMS audit process measures the level of communication, comprehension, and compliance (the 3-C’s) of the Quality Manual and overall QMS system throughout the organization. A very effective way to increase awareness of key attributes of the QMS like the Quality Policy is to incorporate this into the audit. If an employee cannot recite the Quality Policy (either from memory or from a badge, card or poster), that would constitute an audit finding. Another method for maximizing the potential of “finding free” audits is to audit the line workers, not the department supervisors. Demonstrated audit competence of the people actually doing the work validates the strength of the training program, plus generates the collateral benefits that will be discussed in Pt. 2 next week.

When asked to discuss supply chain strategy, I am often greeted with the response “Yes of course, we have a purchasing department”. Supply Chain Management has progressed far beyond the old school purchasing mentality to become a key component of the modern business organization. We are all just pieces in the supply chain puzzle that is responsible for getting the ultimate customer’s product to market.

The fundamental concept of Supply Chain Management is based on two core principles. The first principle is that virtually every product delivered to an end customer has gone through a number of touches in a number of manufacturing and/or service organizations. These organizations are referred to collectively as that product’s supply chain. The second principle is that while supply chains have been around for thousands of years, most companies have only been concerned with what was happening “in their own sandbox. Few businesses took the time to understand, much less manage, the entire “chain” of suppliers & activities that were required to transform raw materials into finished, delivered product to the end customer. This lack of understanding often led to extremely dysfunctional supply chains, and of course, unacceptable delivery and quality performance.

A recent Chief Supply Chain Officer Survey shows just how concerned supply chain executives are about their supply chain. Respondents from 18 different market sectors participated in the survey including high tech, industrial, consumer products, automotive, aerospace & defense, and medical equipment. Interestingly, over half of the survey participants value the supply chain function as equal to sales/marketing, R&D and product development.

Lessons from Lombardi

It’s about Winning: Lombardi saw the importance of winning in any game; in life and so on. He couldn’t accept defeat as final and he had a single-minded focus when it came to winning football games.  As a leader, it is important to understand that people want to be part of a winning team; which requires a winning attitude. Lead by example, being positive while at the same time persistent. In whatever thing you want to do, there will be resistance and you need that winning attitude to breakthrough and reach your goal with your team.

What it Takes to be Number One: Lombardi famously stated “Winning is not a sometime thing; it’s an all the time thing. You don’t win once in a while; you don’t do things right once in a while; you do them right all the time.” This speaks to the culture of an organization, whether the organization is a football team or a manufacturer. A winning culture is an attitude that needs to lived and breathed by every single employee, every single day.

Outwork Everyone: Lombardi knew that the price of success was hard work, hard work, and hard work. He lived and breathed it with his teams, and this discipline helped them win their championships. You cannot bypass hard work; hard work is the shortest path to success. Show your team the value of hard work by personal example; and as you lead by hard work, your team will follow.

Teamwork is Essential: Lombardi recognized the importance of teamwork and he made sure each and every player understood that “there is no I in team”. No matter how you say it, 2 + 2 = 5; two heads are better than one, synergy, Lombardi saw that teamwork was the only way to win, whether it was in the game, or in life.

KISS: Lombardi’s Packers had only a handful of plays and none of them were overly complicated. He had no laminated cards nor did his players have flip over wristbands listing dozens of plays with multiple options. However, the few that he did have were constantly and passionately enforced and practiced until it became second nature to every single player. Simplicity all but eliminated all misunderstandings and confusion so that everyone was literally “on the same page”.

Chase Perfection: Several former Packer players have described Lombardi’s practice regime of how they would run one rather simple offensive play dozens of times in a single practice until every individual player executed his assignment flawlessly. Over and over and over again with not a single mistake being overlooked or tolerated. Games were exactly the same: mistakes that weren’t tolerated in a loss weren’t tolerated in a win either. Lombardi’s premise was that no team or individual has ever come even close to perfection by accident; the only chance of ever reaching perfection is to actively and constantly chase it.

Look in the Mirror: I would again challenge you to take a look at these Lessons from Lombardi and find any one of these that doesn’t, or shouldn’t, apply to your organization. BTW, ESPN recently voted Lombardi the greatest coach in NFL history.

As the great Vince Lombardi once said, “Perfection is not attainable, but if we chase perfection we can catch excellence.”

Previously published in The PCB Magazine – I-Connect007.com

Create and Execute an Action Plan

An action plan is the method for transforming the process from its current state to the future state. This can be accomplished by using a combination of any of the six sigma methodology associated with best practices, and the appropriate tools from The Lean Toolkit. The action plan for this process resulted in dramatic improvement, ultimately reducing the lead-time to the customer from 8 weeks to 5 days. This was accomplished in a number of ways, beginning with the implementation of a Kanban system at the raw material sub-supplier. Waste was minimized in the manufacturing process in three ways: 1) Elimination of inspection by placing quality responsibility at the source, 2) Removing queue time by changing the flow from a push, to a pull process, and 3) Reducing the number of steps in each process. A summary of the dramatic results is shown in the attached figure. As the cycle repeats, further improvement could be achieved by implementing a Kanban system at the other end of the process; delivery of product to the customer.