Understanding Validation of Production & Service Provision
Understanding Validation of Production & Service Provision

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ON-DEMAND WEBINAR
Access Anytime!

Access the recorded version of this webinar anytime from any computer. Attend when it's most convenient for you. You can access the webinar as often as you like from any location for ONE FULL YEAR from the date of registration. You will also be able to download a PDF of the course materials.

 
LENGTH
One hour
 
 
PRICE
$199
 
 
SUMMARY
From the time ISO 9001 was revised in 2000 to the time the most recent revision, there has been confusion on what processes need to be validated according to the requirements in clause 7.5.2, Validation of processes for production and service provision. This is further complicated by organizations that confuse the validation associated with design to the validation of processes. If you struggle with understanding these requirements, this webinar will help you.


Topics to be discussed include:
  • What validation of processes is and is not
  • Reviewing examples in the manufacturing and service industry
  • Applying the requirements of 7.5.2 to manufacturing and service examples

After this webinar, attendees will understand the requirements in ISO 9001:2008 clause 7.5.2 in a manner to ensure they have effectively implemented them. It will also provide details on any adjustments you might need to make to your current quality management system. This information will help your organization sustain and continually improve its quality management system.


DETAILED COURSE AGENDA
  • Validation of Processes for Production and Service Provision     
    • What it Is vs. What it is Not
      • IS - Validation of Processes that cannot be verified during subsequent monitoring or measurement.
      • IS NOT - Validation of Processes to ensure that they are documented correctly.
    • ISO 9000 Definitions
      • Verification
      • Validation
    • Taking an Exclusion
  • Examples of Processes that cannot be verified by subsequent monitoring or measurement
    • Manufacturing Examples
    • Service Industry Examples
  • Review requirements of 7.5.2 in context of manufacturing and service industry examples.
    • How to define criteria for review and approval
    • Approval of Equipment
    • Qualification of Personnel
    • Use of specific Methods and Procedures
    • Required Records
    • Re-Validating the Process
  • Summary
 
PRESENTER

 

Lorri Hunt has over 13 years of experience in implementing quality management systems in diverse organizations. While employed by Honeywell, she assisted many subsidiaries within the corporation and the Department of Energy, National Nuclear Security Administration with ISO 9001 implementation. She has also worked with small organizations through the New Mexico 9000 program. Through this program she has provided training and coached over 100 organizations on ISO 9001 tools, techniques, and methods that will sustain their organization after the engagement is complete.

Lorri Hunt is an active member of the U. S. Technical Advisory Group to ISO Technical Committee 176. She currently serves in the key position of Chair of Task Group 9001/4, the United States group responsible for developing consensus positions related to ISO 9001 and 9004. Recognized internationally as someone who gets the job done, she has held several international positions on ISO TC176. Most recently she was appointed as the Deputy Task Group Leader to the current amendment to ISO 9001.

Lorri frequently contributes to quality publications and journals and was a contributing author to the ISO 9000:2000 Handbook. She is a frequent speaker at conferences.

Lorri is most often recognized for using her 10 years of experience to assist organizations in implementing ISO 9001:2000 using a common sense approach. She is the president of Lorri Hunt and Associates Inc.

 
HOW DOES THIS ALL WORK?
After you register for the webinar, you will receive a confirmation e-mail. It will contain a link to access the recorded webinar through your Web browser. The e-mail will also contain a link to the course materials. You can access the recorded webinar for one full year from the date of your registration. You will need the link that will be e-mailed to you each time you wish to access the webinar.

PLEASE NOTE: The link to access the webinar will be e-mailed to you immediately after you register. If you do not receive the link, please check your spam or junk mail folder.


Price: $199.00 


Quantity:   

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