Saturday, July 26, 2008

The 33 Strategies of War

I had mentioned previously that I wasn't going to start of "Book of the Month Club", but here's my recommendation for July. I'm still not planning on doing this on a regular basis, but The 33 Strategies of War, by Rober Greene is good enough to make note of.

It's an excellent read for anyone interested in tatics and strategy, and applies to not only war, but business, life, relationships, etc.

Here's the link to this book, as found on Amazon.com:

http://www.amazon.com/33-Strategies-War-Robert-Greene/dp/0670034576


Mark
http://www.masquality.com

Saturday, July 19, 2008

Was Bogus Equipment Sold To Oil Patch?

I'd be remiss in my blogging if I didn't make note of an issue that happened recently here in Houston. Federal charges were brought against individuals who had sold equipment with counterfeit API monograms.

I caught this on the local news, on KPRC 2: http://www.click2houston.com/news/16885342/detail.html


Mark
http://www.masquality.com

Wednesday, July 16, 2008

ISO 9001 - You Might Be In Trouble If...

There are some questions, the answers to which I am unsure...what exactly happened at the end of the TV-series The Sopranos? “Who let the dogs out”? If “it’s not about winning or losing, but how you play the game” - then why bother showing up?

On ISO 9001-related issues, there are answers I am sure of. Several of these relate to ways to tell if there’s going to be a problem during your next ISO 9001 audit.

I’ve decided to make a list of the first 10 of issues that I could think of - not a “Top 10” list, but just the first that come to mind. Since this is being written primarily for companies that have already achieved ISO 9001 certification, I’m leaving out some of the more obvious issues (e.g. missing the six procedures required by the ISO 9001 standard), however, most of these could still apply to an organization attempting certification for the first time.

The first 10 issues I could think of are shown below, presented in the order of the standard (their related clause is shown in parenthesis):

Document Control (4.2.3) - You have multiple versions (revisions) of the same document in use in the work area, or “stray” documents in use without the proper approvals and that haven’t been recorded in the system.

Control of Records (4.2.4) - You can’t find the records you’re looking for, or records that you need when requested. Someone has taken your records and you don’t know who and/or when. If you’re lucky enough to find the records you’re looking for, they’re covered in coffee stains, cigarette burns, and/or food.

Customer Focus (5.2) – You have no customer feedback collected on how you’re performing. If you receive a complaint, it’s taken care of on-the-spot and not documented. You may send out customer surveys or questionnaires, but nobody ever responds.

Quality Policy (5.3) - You don’t have a quality policy posted. It may have fallen off the wall, been taken down, or you may have moved to a new location and forgotten to put it back up.

Quality Objectives (5.4.1) - You have no quality objectives established for the current period, or you have partially developed objectives that use words like “more”, “less, “fewer”, “better”, instead of using quantitative terms. You may have failed to meet your last objectives and didn’t take any subsequent corrective action.


Management Representative (5.5.2) - You don’t have a management representative. Your management representative may have quit, been fired or re-assigned. Worse yet, you may have a management representative that doesn’t know they are the management representative.

Management Review (5.6) - You haven’t performed a management review in over a year. You may have had meetings, but you’re unable to demonstrate anything that comes close to meeting the criteria of the standard.

Competence, Awareness and Training (6.2.2) - You can’t prove the competency of the personnel performing tasks that affect product (or service) quality. You have no established job requirements, and/or you have personnel working and you can’t demonstrate how they’re qualified to do so.

Determination of Requirements related to the product (7.2.1) - You can’t prove any evidence of contract review. Orders may be taken verbally without being documented, or even if taken in writing and there’s no evidence of review.

Design Control (7.3) - Your design controls have lapsed, and now your engineers are free to indulge in their creative pursuits without constraint. Design output isn’t defined, reviews are nonexistent, validation isn’t performed and/or you have no working process to control design changes.


Needless to say, the above is just a sample of the problems that may exist with your Quality Management System (QMS), and it isn’t intended to be an all inclusive list by any means. Since the above list only covers up to clause 7.3 of the ISO 9001 standard, there’s still a lot more that will need to be addressed. You’ll need to perform your own internal assessment prior to your next ISO 9001 certification audit, to identify any other concerns that may exist.

I still don’t know “who let the dogs out?”, but hopefully these answers will help you with your next ISO 9001 audit.


http://www.masquality.com

Monday, July 14, 2008

And Finally...

Two Six Sigma Black Belts (SSBB's) walk into a board room...

They've been asked by company management to review customer feedback data that's been collected over the past year. Based on a scale of 1 thru 10 (10 is highest), each item scored an average of about 7.5, with the exception of one category: "On-Time Delivery".

The SSBB's reviewed this data, and reported their findings at a follow-up meeting. The first Black Belt explained that, based on statistical testing, he "could not reject the null hypothesis". The second Black Belt chimed in "based on the data, this issue is statistically insignificant".

The company went bankrupt six months later. Their dissatisfied customers had all taken their business to another supplier.

This point of this story isn't about whether "On-Time Delivery" was significant or not. The SSBB's where so absorbed by their methodology that they missed the obvious - the customers were unhappy. The actual issue was that the company averaged only a mere 7.5 out of 10 overall.

Bah-dum-bum.


No actual company was harmed in the writing of this example.


Mark
http://www.masquality.com

Saturday, July 12, 2008

ISO 9001:2000 - The Myths (part 1)

As I was researching topics to write about, I realized that I had several quality manuals (and related procedures) on my desk that I had been asked to review. The systems that these documents described were failures; their development had been contracted out to various individuals by management, with less-than-usable results.

While a few of these systems did initially achieve ISO 9001:2000 certification, they weren't sustainable over the long term. For the most part, what I found were "templates"; the same documents obviously had been used over and over, with just a global name change to match each company they had been sold to (in some cases, even the name change wasn't done very well). These were poorly written; their content ranged from banal to clueless and back to obtuse.

While the content of these documents didn't impress me (at times, I was actually concerned), it did give me an idea for a new topic. With so much misconception and misinformation regarding ISO 9001:2000, I figured I'd take this opportunity address a few common "myths" surrounding the ISO 9001:2000 standard and its requirements:

1. ISO 9001:2000 is for Manufacturing - Any type of organization can benefit from the process-based approach that's defined in the ISO 9001:2000 standard. Equally suited to services as it is to manufacturing, ISO 9001 can be applied to a wide variety of industries and firms, from education to architects, to medical practices, law offices and more.

2. Document Everything - The "Do What You Document, Document What You Do" approach was a cornerstone of ISO 9001:1994, which was all about following procedures. This has since been replaced by a process-based approach in ISO 9001:2000, which emphasizes effectiveness and focusing on the output - the result. The 1994 version of the standard required that 20 elements had to be addressed; the 2000 version requires a minimum of six documented procedures. Anything beyond these six is left to the discretion of the organization, as necessary for the effective control of the organization's processes.

3. Write Exhaustive Procedures - There really are no rules on how to write a procedure. Your procedures don't need to have a section for definitions, normative references, responsibilities, process maps, blah, blah, blah. What they need to do is to be appropriate to the organization and its operational needs. Don't write your procedures solely to satisfy an auditor, but rather consider how to achieve consistency and uniformity of the process under consideration.

4. Record Everything - There are a total of 19 different types of records that are specifically addressed within the ISO 9001 standard. Needless to say, these aren't all of the records that could be generated during the operation of a quality management system, however these particular records are considered essential to its effective operation. If the record of a result or activity isn't required to manage the organization effectively and/or satisfy interested parties, it doesn't need to be maintained.

5. Make a Form for Everything - We've seen forms used in the review other forms, forms that document the fact that a form is needed and even forms used to log and/or track other forms. While certain forms are common to almost every system (calibration forms, audit checklists, NCRs, CARs, etc.), it's important to limit the number of forms used to those that actually add value. Just a hint: there's a direct correlation here with records you need to maintain (see above).

6. Memorize your Quality Policy - This is another example of what I'll call 1994 thinking. Employees need to be trained, to ensure they aware and familiar with the organization's quality policy, and they should be able to locate where it is posted. One of the main reasons it's a written policy that's posted, is so it can referred to as needed.

7. You Need a Quality Manager - ISO 9001:2000 requires the appointment of a Management Representative by management of the organization; it doesn't mention anywhere the need for the position of Quality Manager. There's no reason that the responsibilities for your program can't be delegated between various functions within your organization.

8. A Web-Based QMS is better - I've seen companies that can benefit from such systems, but usually they're large and/or have business units that are geographically separated. Smaller organizations can usually do without such systems. Software solutions can be quite complex, and come with a variety of issues including extensive training requirements, costly hardware updates, constant IT support, and changes to existing work practices. The downside of this approach often negates the benefits of the technology.

9. We can get certified in one month (or even a week!) - The whole purpose of keeping records is to provide evidence of conformity to requirements and the effective operation of the quality management system. Without this history, there's no way that you can demonstrate that your system meets the requirements of the ISO 9001 standard. Regardless of how long your system takes to write, you will need several months of records; walk away from anyone that tells you otherwise.

10. Keep Statistics on Everything - Many organizations go overboard on the data they collect, or think they have to collect. Data is only important if it's actually relevant to the organization, and the effective operation of the quality management system. Don't collect data solely to satisfy an auditor; the organization needs to determine what's important, and measure and collect data accordingly. We've seen extensive SPC programs utilizing the latest computer software, when all the organization really needed was a checklist and a histogram.

The first step in properly documenting a management system is separating myth from fact, with regards to the requirements and the intent of the ISO 9001:2000 standard. There are a lot more myths around than I've been able to list above, but that's an article for another day. Now it's back to my review...


http://www.masquality.com