Quality Progress - January 2016 - 53

BACK TO BASICS Best of AUGUS 2015 T BY JOHN SUEDBECK Sufficient Evidence How to apply risk management to supplier evaluations QUALITY PROFESSIONALS make the requirements and obtain sufficient compliance. It could be argued that decisions based on evidence that is evidence to make a decision to move you're still at the selection stage, and a reliable, relevant and sufficient. The the process forward or stop it. The team sample, such as an exhibit batch, may International Conference on Harmoni- must answer the question, "Is the sup- be required to continue managing risk. zation (ICH) of Technical Requirements plier able to meet our quality require- An on-site audit following the exhibit for Registration of Pharmaceuticals ments with regard to a high-level review batch could show sufficient evidence for Human Use ICH Q9 guide provides of the project?" related to adequacy, effectiveness and 1 guidance for applying quality risk man- Next, a technical team may visit the compliance, and provide evidence of CMO site, performing tasks similar to their overall ability to meet your quality With regard to the consideration the management team's. The technical requirements. This is another juncture of sufficient audit evidence, it may be team's questions, however, will be: "Are at which to decide whether you should helpful to begin with the evaluation of they able to meet our quality require- continue. a contract manufacturing organization ments for a more detailed review of the (CMO). For many organizations, a CMO project, and do they have the technical risk is continually managed by data supplier may represent the greater risk ability to meet our quality require- analysis and project management activi- and challenge for obtaining sufficient ments?" ties. Note that the focus for sufficient agement to supplier evaluation systems. evidence. You begin managing risk by After these visits, adequate project If you go forward with the supplier, evidence has leaned heavily on whether identifying and documenting your qual- management can be the most powerful the supplier can meet quality require- ity requirements and clearly communi- tool for managing risk associated with ments. This same approach can be used cating them to the supplier. a contract manufacturer. Who should for all of your suppliers in determining The senior management team may provide this talent? A strong argument whether you have collected sufficient visit the CMO site to help communicate can be made for the contract manufac- evidence. turer. The customer may Applying risk management to the supplier evaluation system can be better provide details for understood when you begin with the project coordinators to basics, collecting reliable, relevant and ensure timely, efficient sufficient evidence. QP communication of information between the customer and supplier. After a project plan is generated, it should be reviewed by the auditor for adequacy, giving you more sufficient evidence for a decision about the supplier. An on-site audit at this point may reveal evidence of adequacy, effectiveness and NOTES 1. ICH Q9 is a U.S. Federal Drug Administration standard on quality risk management developed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. For details, visit http://tinyurl.com/fdarisk. 2. For more information on reliability and relevancy of audit evidence, read John Suedbeck, "Solid Proof," Quality Progress, June 2012, p. 72, and Suedbeck, "Bucket List," Quality Progress, January 2014, p. 64. JOHN SUEDBECK is a quality assurance supervisor at Mayne Pharma in Greenville, NC. He earned a bachelor's degree in chemistry from Fayetteville State University in North Carolina. An ASQ senior member, Suedbeck is an ASQ-certified quality auditor, improvement associate and manager of quality/organizational excellence. January 2016 * QP 53 http://www.tinyurl.com/fdarisk

Table of Contents for the Digital Edition of Quality Progress - January 2016

According to Plan
Solid Proof
Use Your Head
Stakeholder Management 101
Customer Delight
All About Data
Eight Simple Steps
Minimizing Chaos
Take Note
Pyramid Scheme
Assessing Failure
Which Six Sigma Metric Should I Use?
Turning ‘Who’ Into ‘How’
In the Beginning
Outputs and Outcomes
That’s So Random—Or Is It?
Understanding Variation
Improving a System
Putting It All on the Table
Know the Drill
It’s Fun To Work With an F-M-E-A
Solve Problems With Open Communication
Tell Me About It
Separate the Vital Few From the Trivial Many
To DMAIC or Not to DMAIC?
Breaking It Down
Smart Charting
1 + 1 = Zero Defects
QFD Explained
Curve Your Enthusiasm
Make a Choice
What Is a Fault Tree Analysis?
Successful Relationship Diagrams
The Benefits of PDCA
Creative Combination
Return on Investment
The Art of Root Cause Analysis
Why Ask Why?
Get to the Root of It
Checks and Balances
Calculated Risk
Sufficient Evidence
Sample Wise
Clearing SPC Hurdles
Supplier Selection and Maintenance
Team Advantage
Building a Quality Team
Plan Experiments to Prevent Problems
Substantiation Test
Training Day

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