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Process of following the procedures and processes that are agreed on during a selection audit process. It identifies nonconformances in the manufacturing process, engineering change process, invoicing process, quality process, and also the supplier/shipment process. Supplier audits are analyses that are done to document the relationship between different companies to verify compliance with a supplier’s products and processes.

  • Implementation of an overall quality system.
  • Establishment of documentation control.
  • Control of business records is achieved.
  • Establishment of customer satisfaction.
  • The control of company or business operations is achieved.
  • Implementation of a business management review is established.
  • Non-conforming product control will be done through the supplier audit
  • The supplier audit will help in calibration control and contract review.
  • Information and product improvements can be shared for common gain among suppliers and companies.
  • Accomplishments of supplier measurement that can take place, risk mitigation exercises both proactive and reactive.
  • When there is an existing stand-alone supplier quality management function, strong relationships with suppliers can be created from a customer’s perspective.
  • Knowledge can be integrated with the deliverance of profit-generating opportunities for both organizations and the exploration of additional, above and beyond contrasting business opportunities. This can be achieved through the creation of a supplier quality management function for all those involved such as account managers, supply chain consultants, and supplier performance managers.
  • Ensure customers will have complete confidence that the company’s products and services will always meet or exceed their needs and expectations.

  • Companies that need a supplier audit to verify their compliance with their supplier’s products or processes.
  • Companies that need to improve their Return on Auditing (ROA).
  • Companies that would want to manage their supply quality management system so that they can know that their suppliers comply.
  • The companies that struggle with reallocating their resources such that they cannot keep current projects on schedule while their engineers are out in the field conducting supplier audits.
  • Businesses need to conduct mutual and beneficial audits of their company and suppliers.
  • Companies or businesses that would want to create an integrated auditing process aligned with internal goals and supplier commitments.
  • Companies that require flexibility and consistently structured supplier audit services so that they can execute a value-adding audit program.

  • Site Quality Operations Managers
  • Quality Assurance personnel
  • Plant Managers and Supervisors
  • Manufacturing Superintendents and Managers
  • Regulatory Affairs Managers
  • QC Lab staff

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed. 

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