ISO9001: A Fresh Start part 3 of 5

This is part 3 of my series of radically reviewing ISO9001 for the 21st century. In this post I continue my discussion on how to improve the Quality Audit function in an ISO9001 company. My editorial comments are in [square brackets]. 

Support [of the system]

            Internal Audits contain another opportunity for improvement in this new perception of the ISO9001 standard.  Being an internal auditor is not an easy task as detailed by Karr & Klemens (2011).  The main reason for the difficulties are due to a company culture that pre-disposes employees to consider an internal audit as, at best, a nuisance and, at worst, a waste of time.  A simple change of terminology and work method could change this perception of Internal Audit and lend it a renewed air of respectability and value.  The change in terminology would be from “Internal Audit” to “Internal Assessment” and the change in work method would be from an impartial evaluator to a cooperative consultant.  The new terminology for the auditor him/herself would be “Internal Consultant”.  When coupled with the previously described real-time assessment these simple changes would help improve compliance with the standard and the working conditions of the consultants.  An assessment would be conducted in a similar fashion as the current audit but would be different at the time of the closing meeting.  Having identified the gaps in the department’s activities compared to the standard the consultant would then meet with the functional head and discuss the corrective actions together.  Rather than make an audit report and move on to the next area the consultant would remain engaged with the manager and actively support the creation and implementation of the corrective actions.  This type of knowledge sharing often happens informally with the current method without recognition of this value from higher management (Alic & Borut, 2011).  The new method would acknowledge the value brought by the consultant and when combined with full functional manager responsibility for the QMS will lead to the functional managers requesting support from the consultants rather than dreading their approach.  [Assuming that] ISO9001 is a strategic decision by the management of the company this improvement of knowledge sharing and internal cooperation will lead to improved business performance.
References

Alic, M.; Borut, R. (2011). Managerial relevance of internal audit. The TQM Journal 23(3).

Karr, J. & Klemens, P. (2011). When quality needs an audit. Journal of GXP Compliance 15(4).

ISO9001: A Fresh Start Part 2 of 5

This post is is the second part of my five part series on a systems evaluation of ISO9001. These parts are extracted from a recent paper that I wrote for my DBA. The first post sparked a great discussion in the ASQ LinkedIn group and I hope that this one will do the same. I invite you to join our discussion there! My "editorial" comments for this blog are shown in [brackets].

Reliability [of the ISO9001 implementation system]

            Of the three main ways to assess the system (Management Review, Internal Audit, Analysis of Data) the most popular and well-known is Internal Audit.  An Internal Audit is conducted according to the requirements in the standard which include the assessment that the management system meets the standard and that the system is maintained (ISO, 2008).  The internal audit schedule must be done at planned intervals is typically planned for a calendar year (ISO, 2008).  Internal Audits can be of any length or scope but they must be defined in a procedure (ISO, 2008).  In the author's experience an Internal Audit typically reviews a particular process over one to two days while the number of days required for an External Audit is fixed according to industry standards.  The limited amount of time that is used for an audit means that the auditor may only review evidence of previous activities in the form of records rather than observe the actual functioning of the system in real-time.  The review of records that show past compliance with the system (assuming that the records are not adulterated) does not mean that the system is compliant at the time of the audit.  The most effective way to audit a system is to observe the functioning of the system over time.  An internal auditor should spend at least a week together with the audited function to observe the various activities including actual occurrences such as award of new business, team meetings and customer complaints.  Only by directly observing such activities can the auditor get a real sense of the status of the system.  As detailed later [in a future post in this series], the role of "auditor" would be changed to allow this type of assessment of the organization's quality system. 

Reference

ISO (2008). ISO 9001:2008 Quality management systems — Requirements. Geneva:author.

ISO9001: A Fresh Start Part 1 of 5

Recently I wrote a paper in my Doctoral-level Applications of Systems Theory course about evaluating gaps in ISO9001 and how to fill the gaps. This series of posts is taken from that paper, including references, in order to start a conversation about the future of ISO9001 and quality in general. I welcome your comments here, let's have a great discussion!

Introduction
ISO9001 has been used for more than a decade to help define and assess quality management systems in a variety of industries around the world. Various industry-specific versions of the standard exist that allow more focused attention when necessary while the main standard can be applied to virtually any type of company. Despite this widespread usage and near-universal recognition, there remain fundamental flaws in the design of the standard itself and in the implementation and maintenance of quality management systems that follow the standard. This paper will review several ways that the standard and its implementation could be improved by using system modeling.

Operational Feasibility

The ISO (2008) defines a quality management system as a series of processes with inputs and outputs that define interactions. This process approach is stated explicitly in the standard and is the foundation of the implementation of the standard. Despite the proliferation of the standard over many years, however, there seem to be few companies that actually follow this process approach in their day-to-day operations. The author has personal experience auditing or working in six different companies where it was obvious that, despite some type of ISO9001 certification, the process approach was actually not followed as part of the normal operations of the company. For reasons explained later in this paper, 3^rd party auditors are not motivated to report this fundamental failure in implementing ISO9001. This author believes that the problem does not lie with the auditors or the companies but with the standard itself.

Many companies, whether they have attained ISO9001 certification or not, do not organize themselves according to the process approach as defined in the standard. Regardless of the industry or type of organization, the most common structure remains the functional department organization. This type of structure can be seen in universities, governments, private businesses and non-profit organizations. Despite the application of ISO9001 in many of these types of organizations and the widespread exposure of the process approach worldwide there remains a lack of desire to implement this approach in most organizations. This author posits that this lack of desire is due to a lack of perceived value in this approach to help the organizations meet their objectives. This represents an operational failure in the current situation and the standard should be revised to address this failure and match the prevailing structure of the majority of organizations in the world.

An ISO9001 standard that is bereft of the process approach remains useful if the various clauses and requirements are applied directly to functional departments rather than through an artificial layer of process thinking. This concept removes the process layer while retaining the underlying functional layer and the higher system layer. The clauses and requirements, reorganized, would be very similar to a checklist for the various functions to follow in their daily work. In fact, Hoppmann, Rebentisch, Dombrowski & Zahn (2011) argue that checklists can be one way to effectively document knowledge and best practices. An ISO9001 standard that consisted of the latest best practices, arranged according to functional department checklists, would be much more valuable and easy to use than the process approach. It would be the interface between the functions and the system; the specific items would be clearly defined and would form the content of the standard.

The focus on processes alone can lead to sub-optimization, particularly if the processes are the focus of improvement activity (Conti, 2011). Conti’s concern is that this sub-optimization is not limited to the processes themselves but also affect overall performance. He asserts that this sub-optimization is due to a lack of systems thinking; this may be so but the application of an artificial layer of process thinking between the functional groups and the system hardly seems to be the way to bring the system into more focus. This author believes that the direct connection of the functions to the system, through the ISO9001 defined checklist, will lead to better results.

References

Conti, T. (2010). Systems thinking in quality management. The TQM Journal 22(4).

Hoppmann, J., Rebentisch, E., Dombrowski, U., & Zahn, T. (2011). A framework for organizing lean product development. Engineering Management Journal, 23(1).

ISO (2008). ISO 9001:2008 Quality management systems — Requirements. Geneva:Author.

Quality and SR

ASQ CEO Paul Borawski discusses the intersection of quality and social responsibility in his blog this month. He makes the case thatm like quality, companies can learn to implement SR and save money and increase the benefit to society. He challenges quality professionals to explain what they are doing to expand SR or, if they are not, why not. I'm sad to say that I am in the "not" category at this time. Here's why:

For better or for worse the market is not demanding SR. Quality faced the same challenges 30+ years ago but then people found it valuable and demanded it. Today, quality is required to get your foot in the door in any industry. Environmental concerns also faced the same challenges years ago and the ISO14001 standard was created. This standard was rolled out and in some industries (e.g. automotive) many customers require it. Since customers required it, and indirectly paid for it, it happened. Today SR and the related standard ISO26000 are on people's minds in quality and some organizations but not in the general market. In fact, the ASQ/IBM report mentioned in Paul's blog states that many companies don't see the value in SR; the report states that this may be due to organizations not knowing how to measure its value (p. 22). I think that they don't try to measure it because they don't see the value, not the other way around. They need some kind of external motivation (e.g. consumer, customer, government) to motivate them to develop ways to measure the value, if it's possible.

Rather than finding ways to measure something to then make it appetizing to companies, let's educate our friends and families to create that demand in the general market. When consumers start to demand SR it will force companies to implement it and down to their suppliers, just like quality and environmental requirements before now. Only the market can show the true value of SR to organizations. Only the market can demand it and make it happen.

Quality Beyond Product

What is Quality? This question has been asked in many ways and in many situations over the years, from the most physical (as in product quality specifications) to the most abstract (à la Robert Pirsig's Metaphysics of Quality). It's difficult to find an answer to this seemingly basic idea, even Pirsig declined from defining it even though it was the basis of his worldview.
On a more practical level, we need to not necessarily know how to define Quality as much as we need to know how to apply it in our work lives. Working in the Quality field I know many ways that we apply it everyday, primarily as a way to identify and meet customer expectations. As Paul Borawski mentioned in his blog, however, many people still consider "Quality" to be related only to Quality Control, the decades-old field of inspecting products after they are made. Although this is a critical part of the overall Quality activity in a company it is far from being the only way to implement Quality. In fact, when problems are found in the Quality Control area, it is very late in the process and these problems tend to be much more expensive to fix. A better way is to identify Quality problems further upstream in the process, even upstream from the manufacturing process. One way to do that is to examine our "transactional" or "office" work in the same terms as the manufacturing process. This will help us to find hidden Quality problems in otherwise seemingly normal processes.

One example is the amount of "rework" that occurs when making a product design. Engineers work closely with the customer to design a product that matches the specifications as closely as economically feasible. During this process the design may be passed to the manufacturing and quality groups for feedback. The design can make several rework loops as the other teams give their feedback and the engineers make changes. Few people might consider this "rework" but it is really no different than a product being made in production, problems found in inspection and then reworked. If the three teams sit down together to make the design (as urged by the APQP process) then the rework can be eliminated with huge amounts of time removed (sometimes weeks). I exhorted this thinking during my stint in Japan and was pleased to see the design engineer and quality engineer taking a few hours to sit next to each other at the designer's screen and discuss the 3D and 2D data, making improvements in real-time.

We are so used to using the terms of production in production, let's start to use them in our other work and find much improvement. Quality must move to enforce a mindset of "real-time" improvement and revisions, rather than allowing something, anything, to be passed along that may not be perfect. Such a mindset can really push quality forward in any organization.

Happiness in Quality

Are you happy in your Quality job? That was the question posed this month by ASQ CEO Paul Borawski after he referenced a study in his blog about Software Engineers having the highest job satisfaction in the U.S. For me, my basic answer is "yes" I am happy in my role as a Quality professional, an area in which I've worked for more than 12 years and studied at the graduate level (leading to a Graduate Certificate in Quality).

The main reason that I am happy about working in Quality is that we are one of the few groups in a company that can and usually does interact with all other areas of the business on a regular basis. Just consider the requirements in ISO9001 (ISO/TS16949, ISO13485, AS9100, etc.). As a Management Representative or internal auditor you can interact with top management, Accounting, Human Resources, Design, Safety, Production and Maintenance. And the interaction is at a detailed level as the people need to explain their actions to you and you need to compare them against their procedures and the requirements. No other group in the company has this role and they do not have the opportunity to learn so much about their company. Another reason that I am happy in Quality is that I enjoy preventing problems and working with teams of technical experts to instill high quality in the design and in the process.

That being said, I think that quality as an idea needs to be more integrated into the business rather than as a separate concept. I've made the same argument for Lean and Six Sigma in previous blogs and I think that quality also needs to follow the same route, to be more embedded in the thinking of everyone in the business but most especially in the minds of top management. Businesses need to find a middle ground between the relative extravagance of Japanese quality (highly leveraged companies with lots of resources) and the bare-bones "good enough" attitude that permeates much of American quality today (minimal leverage and resources). There is a middle ground that must start from the mindset of the management of the company. Apple is an example of a publicly traded American company that thoroughly trounces its competitors (including Japanese Sony). How do they do it...? Why can't we do it...?

I think that we need to look at Quality differently. Rather than aping Toyota's processes for lean (much of which was learned from Henry Ford who wrote about it 90 years ago) we should find the new Vanguard of Quality, Quality 3.0 for the 21st century. To think differently not only about Quality but about how we conduct our business in general. If we can do that then I will be truly happy working in Quality....

"Selling" Quality

When I think of "selling Quality" as Paul Borawski described in his blog I think that what we are really trying to sell is the "Quality Department" or the "Quality Tools" or some other concept that implies an additional cost to an organization. If people understood that Quality can be free then there would be nothing to sell; anyone would want higher Quality if they didn't have to pay anything (money OR effort) to get it.

The act of selling should be redirected as an act of education. Those C-level workers need to understand that the tools to be successful have been around for decades. In fact, the two big improvement initiatives of recent times, Six Sigma and Lean, have been around for a very long time. Six Sigma is simply a consolidation and repackaging of the statistical tools first promoted by Shewhart, Deming and other quality experts since the 1920s. And Lean, while being reintroduced to America by the Japanese 30 years ago, actually started during the time of Henry Ford (read My Life and Work for Ford's early description of just-in-time, decades before the Japanese learned of it from him). No need for some consultant or expert to teach their organization (and charge exorbitant fees to do so), the knowledge is freely available; however, the will must be there to correctly use them. That's the main reason that the Japanese have been so successful, they thoughtfully and thoroughly apply the tools in everything they do. These two things, knowledge of the tools and their correct application, can lead to much success for any organization.

Our responsibility as quality professionals is to educate our superiors and peers to the free nature of quality tools and how to correctly apply them in our organizations. We need to "de-mystify" Quality and make it a part of everyone's work, including and especially the C-level workers. Once they can understand that then we can go a long way to adding more value to our organizations and society.