Factory Audits

All articles in the “Factory Audits” category.

To Avoid Fake Suppliers, Keep This Checklist Handy

To Avoid Fake Suppliers, Keep This Checklist Handy

Factory Audits
By The Pro QC Quality Assurance Team Last week we discussed avoiding fake suppliers and scammers when sourcing medical personal protective equipment (check out that article here: Avoid Fake Suppliers of PPE & Scams). This week we’re taking you through the checklist you should have on hand when investigating a supplier for sourcing any product. […]
Connecting Stakeholder Theory and Social Responsibility

Connecting Stakeholder Theory and Social Responsibility

Factory Audits
An article we recently contributed to ASQ’s Quality Management Forum (Winter 2017) connects Stakeholder Theory and Social Responsibility (SR). “Edward Freeman described Stakeholder Theory as a proactive approach to corporate social responsibility (CSR). Looking outward to groups or individuals impacted by an organization’s activities, Stakeholder Theory encourages organizations to identify key entities affected and consider […]
Understanding the Supplier Audit Process

Understanding the Supplier Audit Process

Factory Audits/Supplier Management
Supplier audits are critical in fostering continual improvement, emphasizing defect prevention, and aiding in the reduction of variation and waste in the supply chain. A supplier audit process scrutinizes factors that could lead to increased costs or financial losses due to supplier underperformance. Watch our video: Supplier Audit Process Components An effective supplier audit process […]
5W2H of Process Audits: What You Should Know

5W2H of Process Audits: What You Should Know

Factory Audits/Quality Control
We’ve used 5W2H to discuss Product Quality Control before, and now we’re using this popular tool to provide insight regarding process audits. Who? Quality auditors are often certified and/or have other applicable training specific to the types of audits they perform. Quality auditors must be professional, ethical and objective. They must be able to select […]
On-Site: What’s a C-TPAT Security Audit?

On-Site: What’s a C-TPAT Security Audit?

Factory Audits
I’ve recently returned from a visit to our offices in China where I was able to attend a C-TPAT audit with our Supplier Development Manager, Jean Champlain. A C-TPAT audit isn’t quite as common as a general QMS or ISO 9001 evaluation, but the information generated has significant value when you understand the scope. “C‐TPAT […]
ISO 13485:201X Preparation (Medical Device Audits)

ISO 13485:201X Preparation (Medical Device Audits)

Factory Audits
ISO 13485:2003 is a standard issued by the International Organization for Standardization that specifies requirements for a medical device manufacturer to maintain a quality management system. According to the standard, these requirements “can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development and […]
Top 3 Benefits of C-TPAT Audits

Top 3 Benefits of C-TPAT Audits

Factory Audits
Although the program started in 2001, there continues to be a lack of understanding regarding what C-TPAT is and how it benefits and adds organizational value. What is it? “The U.S. Customs-Trade Partnership Against Terrorism initiative (C-TPAT) is a voluntary U.S. Customs and Border Protection program designed to improve border security while also accelerating the […]