Creating and Controlling Instructional Documents

Are your company’s instructional documents easy to interpret and effective in explaining to your employees how things are to be done? Are you struggling with the concept of document control?

This course covers the characteristics of effective instructional documents and the process of document control. It provides tools to create instructional documents that direct employees in the correct completion of activities. It demystifies the document control process, showing how easy it is to ensure availability of the most current instructional documents and eliminating one of the highest sources of nonconformities identified during ISO-based management system audits.

Topics covered include:

• Instructional documents
  • Determining the level of detail needed
  • What content needs to be included
  • Who should write them and who should approve them
  • Tailoring documentation to the primary users
  • Terminology, technical language and acronyms
• Document control
  • Simplifying the mystery to show how easy it really is
  • What you need to control
  • Controlling hard copies on the plant floor
  • Use of stamps, “controlled” and “uncontrolled”
  • Explaining “reference” documents

During the second half of the day, participants will use an actual activity at their place of employment to create an outline and devise primary components of an instructional document.

Hours: 8

• Identify the function and importance of essential components and activities of document control, and the type of documents they apply to
• Discuss how to comply with the document control requirements of the ISO Standards
• Recognize the function and importance of primary components of an effective instructional document
• Apply primary components to create or update an instructional document outline

Anyone responsible for writing or controlling instructional documents, such as procedures, work instructions and standard operating procedures

Identification of one of the following to present during the class: an activity at your company that requires the creation of instructional documentation, or an existing document for an activity in need of improvement. For either scenario, be prepared by gathering information about:

• The activity
• The individual(s) expected to perform/complete it
• The skill level of the least competent/least trained person likely to be doing it
• Metrics to assess whether the activity is effective
• Tools required to perform/complete it

8 a.m. to 5 p.m.

TBA

Baird Incubator, Room 206/208

1576 Sweet Home Road

Amherst, NY 14260

Click here for a map.

John, a QMS Exemplar Global Certified Lead Auditor has 40 years of experience in quality assurance and regulatory affairs management at major companies, including Bausch & Lomb, Novartis and Baxter Healthcare. In each role, he has been responsible for global quality system design, manufacturing quality and regulatory compliance. 

John, a QMS Exemplar Global Certified Lead Auditor has 40 years of experience in quality assurance and regulatory affairs management at major companies, including Bausch & Lomb, Novartis and Baxter Healthcare. In each role, he has been responsible for global quality system design, manufacturing quality and regulatory compliance. 

$395

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