Thanks! You've successfully subscribed to the BONEZONE®/OMTEC® Monthly eNewsletter!

Please take a moment to tell us more about yourself and help us keep unwanted emails out of your inbox.

Choose one or more mailing lists:
BONEZONE/OMTEC Monthly eNewsletter
OMTEC Conference Updates
Advertising/Sponsorship Opportunities
Exhibiting Opportunities
* Indicates a required field.

The Anatomy of a Successful Design Plan

Step 3: Monitoring, Measurement and Data Analysis
“What gets measured gets done” is a popular management saying attributed to several famous authors, but the concept of quantifying and analyzing quality issues prior to setting quality objectives is the foundation of Quality Assurance and ISO Quality Management Systems (see Clauses 8.2.3 and 8.4). 

Some design and development managers track accuracy of project completion dates, but this degree of measurement is too crude. I like to think of design metrics as being equivalent to patient data in a clinical study. You need more than patient age for your study reports, and effective targeting of design planning improvement efforts requires knowledge about the deviation from plan for each task in the overall project schedule.

Deviations can be tracked in Gantt charts by the project manager, but the best person to report on the date of task completion is the person responsible for the subsequent task. This will ensure that any transfer delays between tasks are captured.

In order to adequately analyze the overall timeliness of design project tasks, a software database is recommended. This will allow you to make the following types of comparisons:

  1. Sorting and ranking of tasks by duration
  2. Actual vs. planned duration for each task
  3. Variability for each task type between projects
  4. Correlations to product type and task duration or variation
  5. Correlations to vendors and duration or variability
  6. Correlations to seasonality and delays

Step 4: Establish Quality Objectives
Once you have data and data analysis for each of the tasks required to complete design projects, your next step should be to establish quality objectives for the design and development teams to improve their processes.

Your first inclination might be to pick your longest tasks and to make those tasks shorter. However, experience has taught me that the longest tasks rarely offer huge opportunities for shorter timelines. Instead of focusing on the longest tasks, target tasks with the greatest variability. Variability in duration of tasks disrupts subsequent tasks, and variability may result in changes to the critical path of the project. If you can eliminate the variability of tasks, you can reduce buffer lead time in your over- all project and launch dates will become more predictable.

For assignment of these quality objectives, consider assigning each V&V testing SME to monitor and report on the progress of the quality objectives for the task(s) they own.

The SMEs may also consider updating the standardized work instructions to include sections for:

  1. Planning and preparation (see Step 5)
  2. Preferred vendors
  3. Monitoring and measurement of the testing process
  4. Quality objective reporting
  5. Process for initiating corrections/corrective actions


Security code