How ISO 9001 and Lean Make Up for Each Other’s

WeAkneSSeS

ISO 9001 Weaknesses

1. ISO 9001 only requires continual improvement. These are periodic improvements driven by a customer complaint or an internal audit finding.

There’s always a good chance that no improvements will be made within an organization for entire days if it abides by only a continual improvement process.

Lean is about continuous improvement, or kaizen. Lean culture ele-ments, such as leader standard work, daily accountability meetings, visual management, and leadership discipline, as defined in David Mann’s book Creating a Lean Culture, drive improvements made every day, by every-body. As described above, Annex B does encourage continuous improve-ment activities. It just doesn’t call it continuous improvement.

Lean encourages “respect for the people.” Respect for people includes allowing all people to make improvements in their area of responsibility, not specialized people from different departments, like those who might wear special Belts, whether they are Black, Green, or Yellow.

2. ISO 9001 does not define how to improve, it just says do it. This is not necessarily a bad thing. We should be smart enough to develop our own ways, our own style, our own methodologies. But we don’t. So, in typical American fashion, we copy the tools of Toyota. If we only knew how to do root cause analysis well, we could have developed our own 5S, TPM, value stream mapping, or quick changeover processes. No one taught Toyota these tools. They developed the tools on their own as they stuck to their principle of getting to the root causes of problems.

Lean does give us the tools to, as ISO 9001 states, “continually improve the effectiveness of the quality management system,” if we so choose to use

them. We could choose to use these proven tools, integrate them into our quality management system, and improve upon them.

3. ISO 9001 does not force us to look for and reduce waste . . . specifically. ISO 9001 does state repeatedly that we must “continually improve the effectiveness of the quality management system.” This means that we should be looking for and eliminating waste. Some might say that reducing waste is improving efficiency, not effectiveness. One might fur- ther argue that improving the effectiveness of a QMS is the same as increas-ing the possibility of attaining a desired outcome (for example, fewer rejects or customer complaints, on-time delivery) and that improving its efficiency is more synonymous with doing more with less resources through waste identification and reduction. But I would contend that keeping effectiveness separate from efficiency is like keeping quality separate from lean. Most people associate “effectiveness” with “quality” and “efficiency” with “lean”

(even though one of the 8 process wastes is “defects,” a term usually associ-ated with quality, or lack thereof). I teach my students that one example of auditing for effectiveness is looking for and identifying waste. This is why:

if there is excess inventory, it will lead to defects either in quality, profits, or on-time delivery (building too much of the wrong stuff and being late in delivering the right stuff). It leads to not attaining a desired outcome—

the definition of effectiveness. If there is excess transportation within the facility, it can lead to quality problems and on-time delivery problems—

again not attaining a desired outcome—or a lack of effectiveness.

In what I refer to as the spirit behind ISO 9001, ISO 9004:2000 ( Quality management systems—Guidelines for performance improve-ments) also encourages us to audit for both effectiveness and efficiency.

Effectiveness and efficiency are intimately related. This is why Dr. Deming stated that the way to increase productivity (efficiency) is by improving quality (effectiveness).

Furthermore, in section 7.5.1 of ISO 9004:2000, it is stated:

Top management should go beyond control of the realization pro-cesses in order to achieve both compliance with requirements and provide benefits to interested parties. This may be achieved through improving the effectiveness and efficiency of the realiza-tion processes and associated support processes, such as

• reducing waste

If we were living by the spirit of ISO 9001, we would have known that reduction of waste is important to any quality management system without having to wait for someone from Toyota to teach us.

Since the ISO 9001 standard does not specifically use the words

“efficiency”—as ISO 9004:2000 does repeatedly—or “reducing waste,”

and since many people only associate efficiency, and not effectiveness, with waste reduction, many people do not see ISO 9001 as encouraging waste reduction and the lean movement. What a shame! More importantly, what a waste!

4. ISO 9001 does not necessarily encourage employee involvement.

Even though the third principle behind the ISO 9001 standard is “involve-ment of people,” there really is no requirement within ISO 9001 that compels or encourages employee involvement. ISO 9001 requires communicating to the employees how effective the quality management system is, it requires quality objectives to be relevant at each level within the organization, and it requires the organization to ensure that the employees are competent to do their jobs, but it does not require all employees to be involved.

Lean does encourage all employees to be involved.

Lean Weaknesses

1. There are few provisions in lean to help sustain improvements.

A quality management system is all about controlling operations.

Section 4.2.1 of ISO 9001 states that an organization must have

“documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.” Furthermore, control systems such as internal audits, management reviews, and verification of effectiveness of actions taken are required within an ISO 9001–based QMS. These requirements should all help sustain improvements made.

2. Training in lean tools is oftentimes initiated randomly, without a plan. Internal audits can point out weaknesses and wastes and should be used as an initiating point for kaizen events or training in a specific lean tool. When done properly, corrective and preventive actions, quality planning, and management reviews should also be used to initiate kaizen events and/or training in a specific lean tool.

3. Lean does not require document and record control. Even though there are document requirements in lean, like standard work combination sheets, job breakdown sheets, leader standard work, and kanbans, there are no requirements for controlling them.

Of course, ISO 9001 requires both documents and records to be controlled.

4. Lean does not require root cause analysis to be performed prior to implementing actions. Most lean books do suggest doing root cause analysis, yet, in practice, very few companies really do root cause analysis prior to taking any lean actions or during kaizen events.

ISO 9001 requires RCA to be done. If all waste were properly identified on a corrective and preventive action form, then root cause analysis would be properly done rather than haphazardly selecting a lean tool to use. The root cause of the problem would point to what lean tool should be used, if any at all. The root cause should also determine what training is required for that particular problem at that time, not at some random time as is done within many organizations.