Posts Tagged ‘9000’

Reasons ISO 9001 projects fail or succeed

September 26, 2011

Big Q thinking says everything the organization does is for quality. Organizational thinking in this way can result in highly successful holistic system development projects. Some organizations, though, are stuck in little-q thinking, perhaps kept in that state of mind by their dying QC department.

Since 1986 here are four reasons we have observed for organizations failing to obtain the full benefits of ISO 9001:

1. The leaders are not willing volunteers in developing their system.
2. The leaders ignore the system that actually is their organization.
3. The leaders delegate implementation of procedures written around ISO 9001 instead.
4. The quality professionals do not include the financial processes in the management system.

The key to developing a process-based management system is to go with the flow of work in the organization.

Embark on a voyage of discovery rather than implementing a standard:

A. Discover what the organization already does to determine customer requirements (and get paid for meeting them).
B. Discover what the organization already does to fulfill these and other requirements.
C. Discover the processes in the management system (and determine any new ones needed by the management system).
D. Discover what is done in each process to prevent nonconformity instead of how nonconformity is detected.

Telling an individual to implement ISO 9001 is not a good idea. The system development project needs a cross-functional team that is able to analyze its system, determine its key processes and analyze each of those key processes and their interactions.

Just a few of the management system’s processes need to be newly designed and implemented after training of the process team.

Respect the system that is the organization otherwise the system development project will fail. One way to do this is to use the “as-is rule”. Document the process lightly as it is not as you would like it to be. Then, by using and improving the management system it will cause any needed improvements and grow the detail where needed.

What if the process is so bad it does not conform to the standard? Well then, use the two-week rule: record the nonconformity and say “you have a fortnight to correct the process then we will re-document the improved process as it is”. If too difficult to correct in two weeks then feed the nonconformity into an early corrective action using the newly developed management system.

A summary of common mistakes:

i) Leaders not showing their commitment to requirements.
ii) Putting the documented procedure ahead of the process.
iii) Ignoring the system that is the organization.
iv) Implementing ISO 9001 instead of developing the organization’s existing management system.

The system should help people to determine and meet requirements including the requirement for continual improvement. The procedures should be owned by the people not the “we know best department”. That way QA is delivered as a result of everyone using their management system to fulfill requirements.

Learn how to do this for yourselves here.

Avoid “ISO Implementations”

December 12, 2010

Organizations should use the ISO 9000 family (particularly ISO 9001) of system standards to develop and improve their management systems so they are process-based to assure mission accomplishment.

Instead, many if not most organizations implement ISO 9001 to end up with another layer of documents competing for management attention with the management system that runs the organization.

Any organization that has applied our methodology (first published for all to use free of charge in 1986) will have developed the management system that actually runs the organization.

The biggest reason for poor usage of the standard is organizations feeling they are made to obtain certification.

Reluctant conformity leads to many dismal organizations.

Instead of selling certification, we want to know what our clients want to achieve with, and as result of developing, their process-based management systems.

Most of our larger clients do not bother with certification (although many do with their mission management systems).

These days we spend more time replacing sets of burdensome documents with process-based management systems.

What is difference between ISO 9000 and Six sigma as quality standards?

June 30, 2010

On being asked to summarize the differences between two quality standards, ISO 9000 and Six sigma, this is how I replied:

A. ISO 9001 is a management system standard.
B. Six-sigma is a statistical description of process performance.

A. ISO 9001 focuses organizations on their management system that governs the processes that yield products. At the system level ISO 9001 is inviting organizations to address common (system level) causes of process variation. The process-based management systems specified by ISO 9001 can be used to assure product quality and manage continual improvement (to add value faster and prevent loss sooner).

B. Six-sigma is a continual improvement methodology. Most organizations run at two or three sigma.  Six-sigma focuses on designing products so they can be made with fewer defects and on running projects to progressively remove the most costly assignable causes of process variation. Many organizations mistakenly focus their six-sigma efforts on manufacturing before product design. Six-sigma literally means 3.4 defects per one million products. I understand that US airlines with the FAA run their safety processes at about 7-sigma.

So, A and B are designed to work together. Most text books do not mention the 10 to 20 year investment that Motorola, Allied Signal and other six sigma leaders made in developing their management systems before investing in six-sigma. Consequently, perhaps, many organizations using these books have neglected their systems and waste money on their six-sigma efforts because they are let down by inadequate management systems.

To summarize, ISO 9001 specifies a process-based management system which could include its six sigma improvement process.  So, both are compatible and many would say that you should first put in place the organization’s process-based management before investing in six sigma training to turbo-charge the system’s improvement process.

In conclusion, develop your process-based management system first. Run it to assure quality and prevent pollution for a few years. Then invest in six sigma to supercharge your continual improvement process to yield even more cost savings from design, production and delivery.

Please note that certification is not necessary for this but may provide marketing benefits.