Posts Tagged ‘iso 9000’

A Quality Policy for ISO 9001 Standard

Wednesday, April 15th, 2009

ISO 9001 Standard requires a business to establish a quality policy. Specifically, “The management” of a company to “ensure that the quality policy”:

- Is appropriate to the purpose of the organization;

- Includes a commitment to comply with requirements;

- Includes a commitment to continual improvement of the effectiveness of the QMS;

- Provides a framework for establishing and reviewing quality objectives;

- Is communicated and understood within the organization;

- Is reviewed for continuing suitability

One may ask, why we started talking about this requirement. There is a very good reason. Quality policy defines the top-level commitment of your company’s management to establish a QMS in accordance with a particular standard. The reason to talk about it is that most quality policies, per my more than decade long experience as a consultant and an auditor, did not meet requirements of the standard.

Let’s take a look at a few examples of quality policies. If you open your browser and type “iso 9001 quality policy”, you will see a list of companies that placed their quality policies on their Websites. For example, let’s take a look at a few of them:

“It is the policy of [Company name] to provide a range of [services] which is reliable and consistent with the expectations and requirements of its clients; the Company’s objective of consistent high quality performance is met by mandatory adherence to protocol, through staff training and the development of personal responsibility for all personnel, together with the provision of adequate resources, according to the principles of Quality Assurance. Company policy is to review and update as necessary the Quality System through the mediation of a Quality Team, whose members undertake the responsibility of ensuring that the Quality policy is understood, implemented and maintained at all levels within the Company.” Can we say what standard this company is compliant with? Do you see a commitment for continual improvement of the effectiveness of the QMS? Do you understand how this company establishes and reviews their quality objectives? I did not find answers to these questions. However, the policy does commit to communication and understanding of its quality policy and review for suitability.

Let’s take a look at another quality policy: “We at [Company name] are committed to value oriented quality from the perspective of the customer. Quality of workmanship and service are encouraged without adding unduly to cost. Quality is primarily dependent upon individual commitment and acceptance of responsibility by each employee for the quality of the products and services offered, both internal and external to the company. Efforts of continuous improvement focus on enhancement of product and process reliability and customer satisfaction.” Besides questionable language, this quality policy really does not have anything to do with ISO 9001 2000 standard requirements. If we compare it to the set of requirements, we probably will not find a single requirement that is addressed in this policy.

I did not select these examples because they did not comply with the standard. I picked them from the top of the search results, just to show that most quality policies were not written to meet requirements of the standard. If you think these examples are bad, wait a moment. One of my clients came up with a quality policy that is out of this world: “I improve the Quality of Patient Care and all things [Company name]” No! I am not kidding and I did not misspelled or took any words out of this regretful quote!

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ISO 9001 Controlling forms

Wednesday, April 15th, 2009

Do you control your forms within your ISO 9001 quality management system? If you do, you are on the right track. One of the divisive issues with interpretation of ISO 9001 and other standards is control of forms. Various organizations treat forms differently than other QMS documents and do not control them. Per ISO 9001, element 4.2.3, “Documents required by the quality management system shall be controlled.” Let’s investigate if a form qualifies to be a “document” that “shall be controlled”.

Forms and tables are frequently used as quality management system documents. Very often, it is not necessary to write a traditional instruction with the purpose, scope and instruction sections, if a simple table is sufficient to provide these instructions. One of the typical nonconformities that companies get during audits of their quality management systems is against forms that are not part of the documentation system.

Frequently, being asked about not controlled forms, my clients reply: This is “just a form”. I always wonder why should a form be treated differently than any other instruction or a document? If a form is not controlled, how would we know that we need it to begin with? If a form is not part of your ISO 9001 QMS, it cannot be referenced! If your forms are not controlled, how would anyone know that you use the latest revision? Well, exactly what is a form? A quick test will help answer this question. If we have a list of directions telling us to:

- use a 2-column table

- enter your company name into the first column

- enter your company’s Web address into the 2nd column

Most likely, we all would call this three-line guidance an instruction. So, since this is an instruction, it shall be controlled, right?.

OK, now, let’s assume, somebody gave us a two-column table. We also were asked to fill it out. The first column was titled “You company name” and the second column “Company URL”. I bet, most of us would enter our business name in the first column and our URL in the second. Does it mean that we treated this table as an “instruction”? We just did!

These two examples, demonstrate that our first three-line instruction in English (that needs to be controlled), serves the same function, resulting in the same output, as the second form. Therefore, the form as an instruction and “shall”: be controlled as well.

It appears that the puzzlement about forms and their control comes from the fact that forms serve 2 purposes. Blank forms are instructions in tabular language. After a form is filled out, it becomes a record. Records, as a rule, do not have a part or document number or a revision level. Records are controlled by different processes. Remember this and treat your forms as instructions controlled by your documentation procedure. There are a couple of tests you may take when you are thinking about not controlling your form.

- If you created a helpfull form and found it had been changed, would you like to know who did it and why?

- If you changed your form, would you like your employees use the most resent revision?

- If you were on vacation, would you like folks to be able to find your form just by using a reference to it?

If you answered, “yes” at least once, your form is a definite candidate for revision control, and falls under the scope of your ISO 9001 2008 documentation management process.

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Dimensional Verification of Steel and Iron Castings

Friday, February 20th, 2009

One key benefit of steel and iron castings is the ability to be formed into complex, organic shapes that are not easily duplicated in fabricated, or even forged parts. Because of this, castings can achieve significant cost and labor savings, but these complex shapes can be quite difficult to inspect with traditional dimensional inspection techniques. The typical dimensional testing toolbox begs for a few specialty items to complete the task adequately.

In addition to the complex shapes that are common for castings, a steel or iron cast surface will be textured by the molding material that the molten metal was poured into, typically bonded sand. This surface texture can affect the repeatability and accuracy of the inspection if care is not taken during the measurement process.

One important issue that complicates the dimensional inspection of iron and steel castings is the draft angle that is required on patterns that are used in sand molds. Draft angles are a manufacturing requirement of the sand mold process that allows the pattern to be drawn back out of the sand after the impression is made. These draft angles are rarely shown on casting blueprints and solid models but are usually noted on the prints as: Draft not to exceed 1.5 Degrees, or something similar.

The dimensional inspection of castings has traditionally relied on the standard hand-tools that reside in most inspectors toolboxes: height gauges, calipers, radius gauges, snap gauges, tape measures, etc. These hand tools continue to play an important role in the inspection process, but, because of the unique issues with castings as noted above, they cant always be relied upon for the complete dimensional inspection that may be required. In addition to standard hand tools, Spokane Industries uses both a traditional, table-based Mitutoyo CMM (Coordinate Measuring Machine) that has a 24x24x18 working volume and a Faro-Arm with an 8-foot sphere working volume.

The traditional CMM is primarily used for the measurement of smaller, investment castings produced in our lost-wax facility as well as for the castings that are further processed by machining. The Faro Arm is a portable, articulating-arm CMM that allows for much more complete and detailed measurements than would be possible with either hand tools or the traditional CMM. Spokane Industries uses a Faro Arm that has an accuracy of plus or minus .003 of an inch. Although this accuracy is not as precise as a standard, table-based CMM it is more than acceptable for the tolerances usually applied to iron and steel castings.

The Faro Arms measurement software contains all the standard measurement tools that are common in most measurement software packages: plane, line, distance, circle, etc., but the Faro Arm gives the dimensional inspector the ability to digitally trace the contours of the casting and compare the CAD data directly against the trace. This tracing capability of the Faro Arm is accomplished by moving the tip of the arm against the feature of the casting that needs measuring.

The software will record the path of the tip as digital points or small, stitched-line segments. These points or line segments can then be measured in the software. Because of this free-form recording of the actual shape of the casting within the software, the dimensional inspector is able to record the true shape of the casting that can be measured, viewed on-screen, emailed for review, and rechecked even if the casting is no longer present. These features allow Spokane Industries quicker, more accurate dimensional inspections of castings that can be communicated with our customers via traditional dimensional reports, CAD/actual casting scan overlay, or a combination of both.

David Jolin, Quality Assurance Manager at Spokane Industries states, Another advantage of this scanning capability is to reverse-engineer existing castings that may not have a blueprint or cad-data. This is especially helpful if a customer has only a casting to provide to Spokane Industries to copy. Spokane Industries can scan the casting with the Faro Arm, generate a blueprint and CAD model and submit these back to the customer for review and approval. Once approved, Spokane Industries would then create the pattern for the molding operation, and then pour a first part sample. This sample can then be confirmed back to the created and approved blueprint, as well as against the scan of the original part.

The realm of dimensional inspection has moved far beyond the days of hand-written dimensional reports listing the results to the nearest fraction of an inch. The advancements that computer-aided inspection systems and the digital age have spawned allow us to produce parts and inspect them with more precision and detail than ever before. This increased detail results in a better understanding of the casting process that encourages engineers to design even more complex castings. As customer expectations grow, so does the ability of our QA department to meet and exceed them.

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