The Best Choice

Earlier this month, in Are You the Cheapest or the Best?, I discussed the choice between the cheapest or being the best. Just to briefly continue this thought - given the choice, which would you rather choose (cheapest or best) for each the following?


1. Pediatrician
2. Lawyer
3. CEO
4. Brain Surgeon
5. Accountant
6. Financial Adivsor
7. Oncologist
8. Pilot


When something's important, "best" always wins over cheapest.


Mark
http://www.masquality.com

ISO 9001:2000 - Control of Records

In order to comply with the ISO 9001:2000 standard, an organization is required to establish a minimum of six documented “system” procedures. The second of these procedures, by order of appearance, covers the Control of Records, and is identified in clause 4.2.4 of the standard as follows:

"Records shall be established and maintained to provide evidence of conformity to requirements and the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records".*

* ISO 9001:2000, Quality management systems – Requirements, Clause 4.2.4., p. 11


What’s a Record?

In order to understand what a record is, we must begin with another standard in the family, ISO 9000:2000, Quality management systems – Fundamentals and vocabulary. In this standard, we find the definition of a record. Simply put, a record is a document, and can be used as an input from one process to another, but in contrast to documents that are purely informative, a record is generated to state results achieved or to provide evidence of activities performed.

It is because of this difference that different rules apply to the control of records than for the control of documents (clause 4.2.3). Records are not issued, revised or tracked by revision. While a record could be amended to reflect new or updated information, the original record would not be affected.


Types of Records

There are a total of 19 different types of records that are specifically addressed within the ISO 9001 standard. Needless to say, this isn’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.

The records that are identified within the ISO 9001 standard are listed below, along with their corresponding clause number (shown in parenthesis):

- Management review records (5.6.1)
- Records of Education, training, skills and experience (6.2.2)
- Records needed to provide evidence that the realization process and resulting product meet requirements (7.1)
- Records related to the review of customer requirements (7.2.2)
- Design and development inputs (7.3.2)
- Design and development review records (7.3.4)
- Design verification records (7.3.5)
- Design validation records (7.3.6)
- Design and development change review records (7.3.7)
- Supplier evaluation records (7.4.1)
- Validation arrangements for processes (7.5.2)
- Product identification records (7.5.3)
- Records related to customer property (7.5.4)
- Calibration and verification records (7.6)
- Internal audit records (8.2.2)
- Product conformity records (8.2.4)
- Records of the nature of nonconformities and any subsequent action taken (8.3)
- Results of Corrective Actions taken (8.5.2)
- Results of Preventative actions taken (8.5.3)


Controls Required

Creating a procedure to meet the requirements established in clause 4.2.4 is a fairly straightforward task. In clause 4.2.4, the ISO 9001 standard provides us with a clear purpose statement, by requiring that the organization ensure that records remain legible, readily identifiable and retrievable. In addition, clause 4.2.4 also identifies what types of controls should be addressed, giving us a basic outline of what needs to be covered in our procedure - record identification, storage, protection, retrieval, retention time and disposition (disposal).

Being given a purpose statement and an outline, the only information we’re missing are the specific controls used by the organization. In this case, the ISO 9001 standard is neither prescriptive nor specific; it leaves the specific controls up to the implementing organization, to define methods that are consistent with its business needs, quality objectives and customer and/or regulatory requirements.


http://www.masquality.com

ISO 9001:2000 - Management Review Q&A

Earlier this year, when I wrote an article titled ISO 9001:2000 – Your Management Review, I hadn’t realized how much interest there was on the subject. As a result, I’m following up on this earlier article with a simple Question and Answer (Q&A) session, which is based on the questions I’m most frequently asked:


Q1: Is a Management Review a formal meeting?

A1: A management review is appropriately named, as it’s an opportunity for top management of an organization to review the performance of their organization’s management system. It’s more than just a meeting however, as a management review includes the collection, analysis and review of performance data, and any decisions and actions related to the results.


Q2: Can a management review be held remotely?

A2: With the technology that is currently available, there’s no reason that telephone and web conferencing shouldn’t be considered. Portions of the review can be performed remotely when it is not possible or cost effective to meet in person. Data can be collected and analyzed electronically, and the results communicated by email or other means.


Q3: Our organization is quite large and geographically dispersed. How can we perform a single management review?

A3: There’s actually nothing in the standard that requires only one management review be performed. For a large organization, this review can be performed at individual levels (or locations) and then consolidated into a final review that is performed by executive management of the organization.


Q4: This is our first management review and we don’t have much information to report. Can we still hold a management review?

A4: You have information to report; the problem is that you just don’t have much data. This in itself is noteworthy, and should also be considered as an opportunity for improving the effectiveness of your quality management system under section 5.6.3 of the ISO 9001:2000 standard (Review Output).


Q5: What is the required interval for management reviews?

A5: The ISO 9001 standard doesn’t specify any specific time frame, other than requiring these reviews to be performed at planned intervals. For a “new” program, I would recommend at least quarterly, and then adjusting the duration to possibly six months or even on an annual basis if this meets the needs of the organization. Personally, I would never go longer than a 12 mo. interval between reviews.


Q6: Prior to implementing ISO 9001:2000, our organization held monthly meetings to review the performance of our organization. While these meetings wouldn’t meet the requirements of the ISO 9001 standard, they were of considerable value to us. Will this need to be changed?

A6: The answer is no. There’s no reason to change what you’re already doing, particularly if it works well for you. I would keep minutes for these meetings however, and use these as a source of review input for when the organization does hold a formal management review.


Q7: Section 5.4.1. of the ISO 9001:2000 standard requires that Quality Objectives are established at relevant functions and levels within the organization. Is the Management Review an appropriate time to address this?

A7: I personally recommend this. The management review is an ideal time to address your organization’s performance towards meeting existing objectives, and for determining new or revised objectives for the upcoming review period.


Q8: What types of records do we need to maintain?

A8: You’ll need to retain records that demonstrate the requirements of the ISO 9001 standard have been met. This should include, as applicable, meeting minutes (dates, attendees, location, agenda, etc.), objective evidence used as part of this review, and any decisions and actions that result (including responsibilities and timelines).


http://www.masquality.com

Purple Cow

I'm not trying to start a Book-of-the-Month club, but I do have a book recommendation. I recently finished this book, and found it not only informational, but also very enjoyable.

Written by Seth Godin, Purple Cow is a great book on how to achieve spectacular growth and distiction for your business.

http://www.sethgodin.com/purple/buy.html

Mark


http://www.masquality.com

Failure by Choice

I'm absolutely convinced that nobody ever goes to work in the morning planning to do the worst job possible. Usually if there's quality issues, there's a greater reason at hand, be it a result of weak systems, poorly conceived processes and/or a dysfunctional corporate culture.

While placing blame on an individual may be the easiest way to address an issue, it is also the least effective, as it does not correct the underlying issues that are to blame. Think nature vs. nurture; there are extreme cases of poor performance that can be attributed on an individual basis, but these are exceptional instances. The majority of the quality issues we face are directly related to how we've chosen to do business.


http://www.masquality.com/

The Solution Isn't New Software

I see a lot of companies turn to software solutions (ERP, MRP, CIM, CRM, whatever...), in a vain attempt to resolve the day-to-day issues they face during the operations. Unfortunately, the problems they are intended to resolve often don't disappear, and in many cases, they are now accompanied by new ones.

There is a whole laundry list on why this isn't a good idea: complex systems, "buggy" software, costly hardware upgrades, on-going IT support, changes to existing work practices, extensive training requirements and more. For a small business, these issues make the decision to implement such a system questionable at best. I personally believe that the larger an organization is the greater the need for such a system, but for a small company, this strategy often is a losing bet.

Like a ruler, a hammer, a level or a saw, a computer system is just another tool; it's an aid to reaching your business objectives. We're easily sold on these systems however, because we just want our business to be "better", and what could be "better" than an all-in-one solution that comes in a box? We've never really considered the specific areas where our business could be improved, and what solutions therefore would make the most sense.

One thing is for certain - making your business more complex isn't the answer, and computers don't always make life easier.


http://www.masquality.com

Improvement Isn't Just A Business Term

I was recently speaking with an individual that considered himself to be an 18-year improvement "expert". My immediate thought was that 18 years is a long time, and with such expertise, this individual should have a really, really successful practice. In reality, they weren't even close. They were content with the long hours and the modest success they had achieved.

For an improvement expert, this seemed awfully inconsistent with their self-proclaimed specialty. If I was looking for an individual to help my business be more successful, I would want to work with someone that was successful themselves. In fact, the more successful they were, the better I would feel about engaging their services.

Almost every business, in every business sector, is concerned with the continuous improvement of the products and/or services they offer. Shouldn't personal improvement be as important, if not more? Many of us get "stuck in a rut" so to speak; we focus on the performance of our jobs and on the success of our employer, but we forget to apply the same emphasis to bettering our personal lives. Like a business, such improvement requires initiative, planning, action and subsequent follow-up. In business, the success or failure of such improvement initiatives is directly attributed to management; in this case, it's all up to you.


http://www.masquality.com

Your Actual Mileage May Vary

In the glove box of my SUV, I came across the original window sticker from the dealer. It said that I should be getting about 18 miles per gallon. I don't know what form of math was used to calculate this average, however I don't think I've ever come close to this goal. Even driving downhill in neutral with a strong gust of wind at my back, it would be a stretch.

With all the recent emphasis on "going green", I have to admit I've considered buying a new car on at least one occasion. Personally, I like SUV's because of their size; with several new hybrids becoming available, the number of options I have to choose from are improving.

There is a fundamental disagreement however between "going green" and buying new car, regardless of how eco-friendly this new vehicle may be. Think about the resources needed to build a new car, and the disposal issues created by your existing vehicle. The trade-off may not be as "green" as you intended.


http://www.masquality.com

Are You The Cheapest or The Best?

Within a few miles of our office, there used to be two restaurants that served Thai food. Both served the same clientele and had similar menus, although one was more expensive. I use the phrase "used to be", as the cheaper of the two recently closed. This wasn't a result of poor a poor pricing strategy or because of inadequate marketing, but because of quality. The second restaurant, which is still in business and thriving, simply served better food.

The lesson here is, when speaking in terms of commodities (be it products and/or services), competitive pricing isn't always the best way to achieve distinction in the marketplace. Would you rather be known as the cheapest, or would you rather be known as the best?


http://www.masquality.com

Flying Cars and a Box of Cereal

When I was much younger, I was certain that we'd have flying cars by now. We'd be able to fly to work, to school, to our favorite vacation spot. Traffic would no longer be an issue. Considering the recent gas prices, I guess maybe it's not such a bad thing that we don't.

I'm sure that the technology exists, but I'm assuming that it hasn't been refined to a cost-effective method of transportation at this point.

When I was much younger, I always had problems opening the inner bag contained inside my box of favorite cereal. In this case, Frosted Flakes. Even trying other brands, I always found a cheaply-made bag inside the main box, that would never open correctly, and almost always, would tear in a manner other than what I intended. As a result, either the cereal spilled inside the box, or in the best-case scenario, the bag was so badly ripped it refused to close properly afterwards. Since the bag wouldn't close properly, I always had stale cereal just a few short days later.

I can understand why we don't have flying cars at this point. I can't understand why no one has addressed the cereal issue yet. Nearly thirty years later and the cereal bag is still cheap. With all of the emphasis modern business puts on continuous improvement and increased customer satisfaction (TQM, Six Sigma, Lean/Kaizen, etc.), why hasn't anyone ever thought to put a zip-loc type bag in a box of cereal?

We get so focused on the methodology and the technical aspects of our approach that we completely miss the obvious opportunities for improvement.


http://www.masquality.com