-->

May 31, 2016

How to Tell if Your Supplier’s Quality System Is Failing

A disruption or deterioration in supplier 
quality can affect a manufacturer's
entire supply chain.

by David R. Butcher

Marketing Communications, MasterControl


A complex global supply chain combined with strict quality and compliance requirements on upstream activities is compounding manufacturers’ efforts to ensure they are sourcing quality materials for their products. For life sciences companies, where precision is critical, the slightest variation in materials sourced, equipment used or processes followed can leave a path of disaster in its wake – from nonconforming materials and out-of-specification products to production downtime and product recalls.


Without a solid understanding of the quality and reliability of their suppliers, manufacturers will struggle to know if a supplier’s quality system is failing, let alone be able to quickly stop the results of poor supplier quality from spreading.

By implementing supplier audits, manufacturers are more likely to gain visibility into whether a supplier’s products and processes adhere to a defined quality standard, as MasterControl Senior Technical Product Manager Terrance Holbrook explains for Pharmaceutical Manufacturing

This article is related to the Product Data Sheet: MasterControl SupplierTo get the full details, please download your free copy.


While suppliers are expected to measure their own performance, manufacturers should also work with them to establish clear quality requirements for their suppliers. Every manufacturer must define its own metrics and key performance indicators (KPIs) for supplier performance, establishing its own requisite characteristics and capabilities of a supplier’s quality system, according to Holbrook, who has more than 18 years of industry experience in manufacturing fields.

There is an endless combination of possible criteria that manufacturers can measure in a supplier’s quality performance and related activities, including: deviations and non-conformances; regulatory certifications; corrective actions; change controls; complaint history; return rates; raw material chain of custody; and batching process and production records.

Using an audit form or survey outlining specific evaluative questions, manufacturers should look for certain signs of suboptimal supplier quality performance, including: high scrap rates or nonconforming product rates; poor/incomplete batch record documentation; and below industry-standard KPIs.

Manufacturers can use the audit findings to identify process, training or documentation issues affecting the supplier’s quality metrics and help guide the supplier to an improved state of quality.

How to Help Your Supplier Reach a Higher State of Quality


After identifying the issues hindering optimal supplier quality, the manufacturer and supplier can together determine corrective actions for the supplier to implement within a specific time frame. The manufacturer should update the supplier scorecard to reflect quality-related problems found during the audit, as well as set up reoccurring supplier evaluations (i.e., mini-audits).

Successfully implementing supplier corrective actions requires a robust, well-managed process that relies less on mandating specific solutions and more on active, ongoing collaboration.

The supplier is probably more familiar with its own quality system than the manufacturer is, so demanding specific solutions can cause more damage than benefit – over-complicating an already-complicated quality system and creating more problems in the future.

Instead, the preferred way to help a supplier reach a better state of quality is to work closely with the supplier to establish open communication, develop and document the criteria for quality performance, and identify major quality problems and corrective actions. By making suppliers part of the quality process, according to Holbrook, manufacturers are “more likely to gain greater visibility into supplier quality, facilitate better quality processes and receive higher-quality parts.”

To learn more about implementing supplier audits collaboratively, as well as how to apply quality management tools to achieve supplier quality success, check out Terrance Holbrook’s article for Pharmaceutical Manufacturing.


David Butcher has been writing about business and technology trends in the industrial B2B space for more than a decade. Currently a marketing communications specialist at MasterControl, he previously served as editor of ThomasNet News’ Industry Market Trends and as assistant editor for Technology Marketing Corp.’s Customer Interaction Solutions. He holds a bachelor’s degree in journalism from the State University of New York, Purchase.









Watch Related Videos:

Demo: MasterControl Quality Management Software
MasterControl Closed-Loop Quality Management System
Improving Quality with MasterControl


Download Free Resources
White Paper: Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance
White Paper: 5 Tips for Getting Executive Backing for a New or Expanded EQMS
White Paper: Six Corporate Oversights of Quality and Compliance Issues in Pharmaceutical Environments
Analyst Report: A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences (LNS Research)