Quality Progress - August 2015 - (Page 64)

BACK TO BASICS BY JOHN SUEDBECK Sufficient Evidence How to apply risk management to supplier evaluations QUALITY PROFESSIONALS make the requirements and obtain sufficient argued that you're still at the selection decisions based on evidence that is evidence to make a decision to move stage, and a sample, such as an exhibit reliable, relevant and sufficient. The the process forward or stop it. The team batch, may be required to continue man- International Conference on Harmoni- must answer the question, "Is the sup- aging risk. An on-site audit following the zation (ICH) of Technical Requirements plier able to meet our quality require- exhibit batch could show sufficient evi- for Registration of Pharmaceuticals ments with regard to a high-level review dence related to adequacy, effectiveness for Human Use ICH Q9 guide provides of the project?" and compliance, and provide evidence 1 guidance for applying quality risk man- Next, a technical team may visit the of their overall ability to meet your CMO site, performing tasks similar to quality requirements. This is another With regard to the consideration the management team's. The technical juncture at which to decide whether you of sufficient audit evidence, it may be team's questions, however, will be: "Are should continue. helpful to begin with the evaluation of they able to meet our quality require- a contract manufacturing organization ments for a more detailed review of the risk is continually managed by data (CMO). For many organizations, a CMO project, and do they have the technical analysis and project management activi- supplier may represent the greater risk ability to meet our quality require- ties. Note that the focus for sufficient and challenge for obtaining sufficient ments?" evidence has leaned heavily on whether agement to supplier evaluation systems. evidence. You begin managing risk by After these visits, adequate project If you go forward with the supplier, the supplier can meet quality require- identifying and documenting your qual- management can be the most powerful ments. This same approach can be used ity requirements and clearly communi- tool for managing risk associated with a for all of your suppliers in determining cating them to the supplier. contract manufacturer. Who should pro- whether you have collected sufficient The senior management team may vide this talent? A strong argument can evidence. visit the CMO site to help communicate be made for the contract manufacturer. 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 compliance. It could be 64 QP * www.qualityprogress.com 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. http://www.tinyurl.com/fdarisk http://www.qualityprogress.com

Table of Contents for the Digital Edition of Quality Progress - August 2015

Up Front
LogOn
Expert Answers
Keeping Current
Mr. Pareto Head
Under Construction
Creative by Design
Coming Together
All the Right Moves
3.4 per Million
Quality in the First Person
Career Corner
Statistics Roundtable
Standards Outlook
QP Toolbox
QP Reviews
One Good Idea
Back to Basics

Quality Progress - August 2015

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