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5 Questions: How Much Value is in Your Quality Manual?

Bill White, Senior Consultant, Quality System Strategies LLC. For this feature, he discusses how to go beyond compliance to acheive real value from quality manuals.

March 1, 2012

3 Min Read

5 Questions: How Much Value is in Your Quality Manual?

For this feature, Bill White, Senior Consultant, Quality System Strategies LLC discusses how to go beyond compliance to achieve real value from quality manuals.

1. How can we get maximum value from our quality manual?

The quality manual should aim beyond just documentation of compliance. Success in a quality management system can happen only if "quality is everyone's business." If the quality manual is just a document pulled out by the quality staff for discussions with auditors, it cannot provide maximum value for the organization. It needs to be a document for everyone.

2. How do we make our quality manual a document for everyone?

There are a few key actions:

Make it understandable. Use everyday language and not "qualityspeak."
Make it short enough to read in an hour or less. Don't try to include all quality management system details. Save details for the next level of documentation.
Include figures and pictures (products, facilities, employees) so it is not all text.
Translate it if you have operations where English is not the primary language.
Give it the "look and feel" of other printed company documents so it is clear that Quality is not a side issue.
Give each employee a copy.

3. Doesn't providing hard copies cause challenges in case of changes?

Nothing that cannot be overcome with planning:

Avoid inclusion of material most likely to change, such as organizational details.
Plan for an electronic addendum easily accessed by all when changes are needed.
Ensure that each employee can tell at a glance from the cover that a new edition is different from the one before.

4. What about expense?

Although the expense of hard copies is a reality, it should be balanced against the consideration that employee inattention to quality concerns can cost millions. Much less spent on quality manuals to give employees a personal connection to the quality management system is money well spent. And the newest printing options can make the cost manageable.

5. What if we want to try it, but just do not have any money available?

Consider how much informtion can be printed on a sheet of heavy stock 11 x 17 in. Folded over this provides 8 columns on 4 pages that can contain a surprising quantity of information. This can be a very cost-effective means for providing a hardcopy manual for each employee. If translation into multiple languages is a consideration, this approach, which forces brevity, can ensure that the manual focuses only on the key messages for all employees.

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Bill White started Quality System Strategies LLC in 2006, when he retired after 30 years at Bayer HealthCare LLC. At Bayer, after 20 years in R&D he worked with colleagues in the mid 1990s to establish the design control system for the diagnostics division. He then became Manager, Quality Systems Strategy, and in that role served as principal architect for the worldwide quality system of the division. As consultant for five years, he has advised medical device companies ranging in size from a few persons to several thousand persons on how best to fulfill requirements of 21 CFR 820 and ISO 13485 while creating quality systems that serve the needs of the companies and their employees.

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