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Welcome to the Whittington & Associates e-Newsletter! Visit and bookmark our web site today: http://www.WhittingtonAssociates.com This e-Newsletter is in HTML format
and may not be displayed properly by some email programs. Please click on
our web site address above to see the e-Newsletter with its proper formatting.
In our February 2004 newsletter, I listed sixteen
guidance documents on auditing practices that are available at the ISO Technical Committee 176 web site. Four new guideline documents
have been released since our February article:
The guidance is primarily aimed at QMS auditors, consultants, and quality practitioners, but is not definitive. The papers and presentations reflect a number of different views in QMS auditing. As such, their content may not always be consistent. It is not intended for the guidance to be used as specified requirements, an industry benchmark, or as criteria that all QMS auditors, consultants, or practitioners have to follow. The guidance documents are available at <http://isotc176sc2.elysium-ltd.net/APG_index.html>.
Auditors often identify nonconformities when calibration practices are compared to the requirements of ISO 9001:2000, clause 7.6. To properly control monitoring and measuring devices, it's important to understand the difference between "monitoring" and "measuring", and "devices" and "equipment". Monitoring and Measurement Monitoring can be defined as watching, tracking, or checking, usually for a specific reason. In clause 7.6, monitoring involves observation and supervision activities (using monitoring devices). Monitoring can involve measuring or testing at intervals, especially for the purpose of regulation or control. Measurement is the process of determining physical quantities, magnitudes, or dimensions (using measuring equipment). Devices and Equipment The word "device" has several meanings. It can be a non-physical device, such as, a plan, procedure, or technique. Or, it can be a piece of equipment. Devices deliver qualitative or quantitative results. Qualitative measures are attribute-based, such as, A non-physical device could be a survey questionnaire. Physical equipment can be grouped in two categories: indicative or measuring. Indicative equipment would something like a low-level fuel alarm, a power on/off indicator, or a go/no-go gauge. Measuring equipment is defined in ISO 9000:2000, 3.10.4, as a measuring instrument, software, measurement standard, reference material, or auxiliary apparatus, or combination thereof, necessary to realize a measurement process (a set of operations to determine the value of a quantity). Use of Terms in Clause 7.6 With these definitions in mind, lets examine the requirements of clause 7.6. The first paragraph of 7.6 addresses both monitoring and measurement, as well as, devices (which includes equipment). However, the third paragraph, including bullets a) through e), is limited to "measuring equipment". Correctly interpreting the requirements of clause 7.6 requires a close analysis of its precise wording. ISO 9001:2000 only requires “measuring equipment” to be calibrated. However, t Where it is not possible to calibrate monitoring and measuring "devices", they should be verified or validated. Examples would be a pilot study for a survey questionnaire, or comparisons for sensory testing. From this description of monitoring and
measurement, as well as, devices and equipment, it seems
unlikely that an organization would be able to exclude all of clause
7.6 from the scope of its quality management system. If it doesn't use “measuring
equipment”, the organization can exclude the requirements of the third
paragraph, bullets a) to e) and the first two sentences of the fourth paragraph.
But what about devices other than measuring equipment? Organizations may
be excluding all of clause 7.6 without considering their use of non-physical
devices.
Note:
This article used information from the auditing practices guidance at the
ISO Technical Committee 176 web site (see first
article in this newsletter) and the book, ISO 9001:2000
for Small Businesses – What to do, Advice from ISO/TC 176, available
at the ANSI e-Standards store for $58.00.
Want to write effective procedures and work instructions?
Then focus on these writing concepts:
This article covers Syntax: putting words together
in phrases and sentences that are easily and correctly read.
Grammar Rules Follow the rules of accepted grammar to
avoid misunderstandings. Even if the grammar errors do not confuse the reader,
they may reduce your credibility. For example, subjects and verbs must agree
in number (“the audits are complete” and “the audit is complete”).
Another error is the intentional omission
of articles (a, an, the). Articles indicate if a noun is meant in a general
or specific sense. For example, “the meeting is attended by the supervisors
of the process area” indicates all the supervisors attend the meeting. However,
“the meeting is attended by supervisors of the process area” may indicate
some supervisors attend the meeting.
Concise Writing Decide what you want to say, and say it
in as few words as possible. Remove every word, phrase, or sentence that
can be discarded without sacrificing clarity or violating any grammar rules.
Thomas Jefferson (1743 - 1826), the 3rd U.S. President and drafter of the
Declaration of Independence, said, "The most valuable of all talents is that of
never using two words when one will do.
Active Sentences An active sentence is one that shows the subject of the sentence acting. For example, a procedure should actively state, "the operator removes the tape". A passive sentence is constructed to have the subject acted upon. For example, "the tape is removed by the operator." Use active sentences, not passive sentences. For example, a work instruction would actively state, “open the valve”, not passively state, “the valve is opened”. Positive Statements Write instructions as positive statements,
for example, “ensure the switch is closed”. Avoid negative statements. For
example, "ensure the switch is not open” may confuse the reader.
Short Sentences Break long sentences into several short sentences containing fewer actions. Punctuation Usage Use punctuation to aid in understanding,
such as, commas to separate items in a list. Use a colon to indicate a list
is to follow. Use semicolons to separate items in a list that contain internal
commas. Use apostrophes to indicate possession, not to make a word plural.
Microsoft Word
Although aware of spell checking, you may
not be aware that Word can analyze document grammar and readability. Click
on Options in the Tools menu and select the Spelling and
Grammar tab. Select the Check Grammar With Spelling box and the
Show Readability Statistics box.
The grammar function can verify subject-verb
agreement, check for extra spaces, and identify missing punctuation or capitalization.
It also spots passive sentences (e.g., "the document is approved by the manager"),
which should be rewritten as an active sentence ("the manager approves the
document").
The document statistics include a Reading
Ease index and a reading Grade Level. Both readability scores are based on
the average number of syllables per word and the number of words per sentence.
The Reading Ease score rates text on a 100-point scale; the higher the score,
the easier it is to understand the document. For most
documents, aim for a score of approximately 60 to 70. The Grade Level score
rates text on a grade-school level. For example, a score of 8.0 means that
an eighth grader can understand the document. For
most documents, aim for a score of approximately 7.0 to 8.0.
The prior article in this newsletter dealt with Syntax, the arrangement of words into phrases and sentences. This article is about Vocabulary. The choice of words is very important in writing easy to read documents that convey the right meaning. Simple Words Use short, simple words that are understandable to the reader. For example, use “orient” instead of “orientate”. Use “finish” instead of “finalize”. Use words consistently. Once you’ve referred to something by a particular name, keep referring to it in that same way. Wrong Meaning Since the document may be read aloud as verbal instructions to someone, avoid verbs that sound alike, but have different meanings. Decreasesounds too similar to Increase; use Reduce instead. Avoid vague words as in, “slowly drain the tank”. Instead say, “drain the tank at a rate no greater than 100 gallons per minute”. Abbreviations An abbreviation is a shortened form of a written word. For example, "amt" is an abbreviation for "amount". If the reader will not understand the shortened form of the word, spell them out or don’t use them. Acronyms An acronym is a word formed from the initial letters of name, such as, IBM for International Business Machines. An acronym can also be formed from parts of a series of words. For example, RADAR for RAdio Detecting and Ranging. The first use of an acronym should be explained: International Business Machines (IBM). Future newsletters will include articles on the dealing with details, expressing numbers, formatting documents, emphasizing text, organizing information, displaying criteria, including lists, and writing alerts (warnings and cautions). If you are interested in taking a course of how to write effective documents, see our Quality System Documentation course description.
Would your organization like clarity and cost-cutting with well-designed product documentation? Well, ISO 7200:2004 should make it easier for companies to communicate with their suppliers, customers, consultants, and other partners by improving the way product documentation is processed in computer systems. As companies spread out geographically,
and as out-sourcing of production tasks and the use of subcontractors increase,
a standardized way of documenting information is required to serve as a stable
means of communication and to reduce the risk of misinterpretation, errors,
and additional costs. ISO 7200:2004, Technical Product
Documentation - Data Fields in Title Blocks and Document Headers,
will facilitate the exchange of documents and ensure compatibility not only
in computer systems, but also in paper-based form by defining a common way
of transferring and presenting information. It will serve as a platform for communication
by helping to facilitate information exchange between involved parties and,
in so doing, help ensure that specified requirements are fulfilled in all
phases of the product life cycle, from design concept via manufacturing,
maintenance to final phase out. The new standard specifies the data
fields used in the title blocks and headers of technical product documents
that will allow information to be identified, recognized, understood, and
properly handled. It is applicable to all kinds of documents for all kinds
of products - in all fields of engineering.
ISO 9001:2000 Lead Auditor
(RAB Accredited) - BSI Management Systems
ISO 9001:2000 Internal Auditor (RAB Accredited) - BSI Management Systems
ISO 9001:2000 Auditor Update - The Process Approach - Course developed by Larry Whittington
Implementing ISO 9001:2000 - Course developed by Larry Whittington
Understanding ISO 9001:2000
Understanding ISO 9001:2000 Requirements (Atlanta Only - $295) - Course developed by Larry Whittington
Quality System Documentation (ISO 9001:2000) - Course developed by Larry Whittington
The above public courses
can be offered on-site at your facility. In addition, we offer these on-site
courses:
To arrange an economical on-site class, please call us at 800-404-7585.
© 2000-2004 Whittington & Associates, LLC. All rights reserved. You may copy this e-Newsletter provided you copy it completely, do not change it, and include this copyright notice. |
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