Each year, STR audits over 10,000 facilities including manufacturing plants, sub-contractors, warehouses, stores and distribution centers. Our detailed independent audits provide companies with essential information allowing them to make informed decisions regarding the adequacy of manufacturing capabilities, quality assurance systems; regulatory compliance, sanitation conditions, along with social compliance and environmental performance.
Quality Systems Audits
An independent audit of quality systems, whether required by law or not, is the best way for a company to ensure that its quality systems and those of its suppliers and/or contract manufacturers are safe and effective.
Our audit specialists are board-certified in Regulatory Affairs (RAC) by the Regulatory Affairs Professional Society or in Quality Auditing (CQA) by the American Society for Quality and are HACCP or OSHA trained.
STR provides quality systems audits which include:
- Current Good Manufacturing Practices (cGMP) Audits – Conducted in accordance with the Code of Federal Regulations, these audits are specifically for regulated industries such as food, food packaging, dietary supplement, pharmaceutical, and medical device.
- General GMP/Factory Quality/Capabilities Audits – Based on ISO principles, Factory Quality and Capability audits determine whether the products being manufactured will be safe and reliable and if required production volume and schedules will be met. Factory audits offer early detection of problems that could result in product defects, production delays, and other issues if left uncorrected. These audits are conducted for non-regulated industries such as toy, toy premiums, textile, personal care, household chemicals, and general consumer merchandise.
- Factory Audits predicated on RoHS – Certified quality auditors determine conformance of the organization’s RoHS management system and if the system is properly implemented. Areas of potential improvement are identified, and the ability of the internal management review process to ensure continuing suitability and effectiveness of the system is assessed.
- Hazard Analysis Critical Control Points (HACCP) Audits – These audits provide an in-depth review of a company’s HACCP plan and include an inspection of the product(s) manufactured, the unit operation, and requisite documentation to ensure that the plan is functioning to all aspects of the seven principals of HACCP. These audits are conducted for regulated and non-regulated industries.
- OSHA Audits – Used to evaluate the health and safety programs within a facility, OSHA audits inspect the working conditions, equipment, machines, processes, procedures, and records to determine if the facility is complaint with the current OSHA regulations based on 29 CFR 1910.
- Sanitation Audits – These audits focus on assessing the sanitation procedures in a food manufacturing facility, as well as on validation review of the sanitation program. Sanitation audits are also conducted for suppliers of direct food contact products for the foodservice industry.
Social Audits
The ongoing monitoring of a supply chain is an integral part of a corporate social responsibility program. STR’s Social Audit is an objective and credible assessment of supply chain conditions, providing valuable guidance on preventive and corrective actions, reducing risk of legal sanctions, and preventing adverse public exposure.
Our auditing methodology has been adapted for work within numerous code-of-conduct frameworks and industries, including garment and textiles, high-tech, hardgoods, home furnishings, and food processing. STR works with global brands, retailers, and manufacturers to customize comprehensive social compliance auditing programs to ensure the integrity of their supply chains. Additionally, we are accredited for social compliance auditing by the Fair Labor Association, Social Accountability International (SA8000), Worldwide Responsible Apparel Production, and the International Council of Toy Industries.
STR’s auditing teams have extensive knowledge of the local languages and customs in regions where they work. Our auditors collect and compare data from observational tours, employee interviews, document review, and management comments, to assess a factory’s compliance to all applicable local legal requirements, international standards, and client-specific code of conduct elements.
