Quality Objective

Creating Quality Objectives

Step 1

• Using outdated/superseded version of SOP, which was causing inaccurate results

Step 2

• Background:

• internal audit found that technicians to be using outdated SOP that was stored on their own computers (changed to technicians because objective states decrease from 5% to 2% so more than one person should be found using outdated version)
• handwriting in the margins of the page
• increase in errors reported

• Need:

• identify why the technicians didn’t have the current SOP version
• check the master list of documents/updates/control
• train staff on new SOP

• Constraints:

• Lack of training for new protocol
• Lack of money and time for training
• Lack of communication between QA manager and technician
• Need staff to check master list

• Resources available:

• QA manager should be able to check SOP use by staff
• Master list is always available

• Resources needed:

• Money and time to provide  training
• Require highly trained staff  

Objective: Reduce failures of document control from 5% to 2% within 2 months

Step 4

• Who will be responsible for coordinating + carrying out action?

• QA manager
• Lab manager
• Technical staff for training

• A time by which the action might occur

• Two months

• The intended outcome of the action

• A decrease in use of outdated SOP from 5% to 2%

Action steps:

• Training + check of SOP version – laboratory manager
• Progress check weekly, report by email, meeting each week, facilitate and monitor training – QA manager
• Attending training, record of training signed and checked by QA – technical staff
• Hold meeting to notify staff that they found employees using outdated SOP version and thus those copies must be destroyed, which would be checked by the QA manager + send minutes to staff that were unable to attend

Quality Objectives

approach to quality improvement:

• set specific goals

• develop action plans to achieve these goals

• periodically review to track progress

• implement to achieve desired benefits.

Action Plans

To be effective, action plans need to be:

• Specific

• Measureable

• Attainable

• Relevant

• Time framed

Responsibility for their implementation needs to be

assigned.