The following eight strategies outline the logic used to create the successful Quality Plan that will help you determine project prioritization.
#1 Identify Directives
Directives are usually identified from a list of goals established by top management and the FDA.
There are typically four areas of concentration to generate the project list:
#2 Identify and Define CTQ’s
CTQ’s are the Critical to Quality attributes to which each project will be graded. Each strategic management team member must agree upon these critical to quality attributes (success factors). All CTQ’s must fall within the directives established above.
#3 Weigh each CTQ
Weigh each CTQ from a scale of (1-5); 1 = the least critical, and 5 = the most critical to operations. The most critical attributes to the firm should be those CTQ’s that could shut down operations or cause a severe, detrimental impact to product quality or worker safety.
#4 Project List
Identify each project that should be placed on the list to be scored against each CTQ. At this point do not worry about prioritization, but simply brainstorm on projects. Reference internal and external audit reports, maintenance project lists and regulatory audit findings with other organizations or other sites within the company. Discuss projects with individuals within each department.
Once all ideas/suggestions have been tabulated, the team can collectively review, add, remove and amend items as necessary. Bear in mind that some projects may be linked to one another (such as completing Project A prior to starting Project C). It would be advisable to combine these projects or, at a minimum, indicate the relationship in the project description.
#5 Assess Budget
Assess each project and determine resources and capital/expenses needed. Do not limit resources and costs to what is available today or who is on-site, assess at this time what is needed to complete each individual project.
#6 Score Projects
Evaluate each project against each CTQ and score using 0, 1, 3 or 9.
0 = Score which reflects no impact to a particular CTQ
1 = Low impact
3 = Medium impact
9 = High impact
All strategic management team members must agree upon the impact of each project for each CTQ.
#7 Total Score
To calculate a total score for each project, multiply the first CTQ weight (determined in step 3 above) times the score applied for a particular project and add to the second CTQ weight times the score applied; continue through all CTQ’s to achieve the total score.
Project = Establish Material Review Board
[GMP (10) x SCORE (9)] + [EPA (3) x SCORE (9)] + … = xxx
#8 Prioritize Projects
To prioritize projects, simply sort the total score of each project in descending order. The higher the total score the higher the priority.
Since this spreadsheet will be the outline of future activities to complete the projects listed in the quality plan, information should be included on “Resources Available”, “Equipment or Services Required” and “Budget”. This information will be of significant importance once the document is approved and the next phase of quality plan implementation begins.
The approval of this document should be made by the Quality Plan Team and by the top management group. At this point, management will need to assess the equipment/services required and the budget for completion of each project. Dissemination of this document to all employees is paramount to focusing the companies collective mindset on common goals with established priority levels.
Establishment of project teams as necessary is part of developing deliverables from the quality plan. The project team prioritization has already been set by the quality plan – all that is needed is to execute the project.
Each company is different with various requirements dictated by site and/or corporate management. Based upon this fact, the quality plan should be flexible and able to fit the “format” for each companies particular needs. Following the outline given in this article, the dread of developing a quality plan should be greatly reduced.
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