Quality audits are an integral part of compliance to regulatory requirements. The FDA requires quality auditing to be performed as part of its Quality System Regulation (QSR).
Audits are an essential management tool to be used for verifying objective evidence of processes, to assess how successfully processes have been implemented, for judging the effectiveness of achieving any defined target levels, to provide evidence concerning reduction and elimination of problem areas. For the benefit of the organization, quality auditing should not only report non-conformances and corrective actions, but also highlight areas of good practice.
We will assess the actual effectiveness of the Quality Management System as well as assure the procedural adherence to the applicable industry standards. Our audit team is able to help you through the process of systematically examining your quality system in the following areas:
FDA regulations (21 CFR 1271,21 CFR 820, 21 CFR 58) require that regulated organizations ensure that critical suppliers…i.e., any organization who performs “any step in manufacture on your behalf” complies with applicable regulations. Jim Colyn & Associates Quality Consultants have the precise expertise needed to assist your organization in the establishment of procedures for the selection, evaluation, and monitoring of critical suppliers. We will help you “stratify” your suppliers, and determine the appropriate level of evaluation required to qualify them, monitor their performance, and, when required, conduct surveillance audits to ensure that those suppliers remain in compliance with applicable FDA regulations, appropriate sections of the AATB Standards for Tissue Banking, and other applicable industry standards (i.e., ISO 9001; ISO13485; ISO 15189).
JC&A trained, qualified auditors, utilizing proprietary comprehensive audit checklists specifically developed for initial qualification and routine surveillance of all types of critical suppliers by on-site audit, including:
♦ Tissue Bank Audits (Tissue Recovery Organizations and HCT/P Processors – designed to ensure compliance with AATB Standards for Tissue
Banking and cGTP regulations).
♦ Medical Device Organizations (ensuring compliance with 21 CFR Part 820 – Quality System Regulations; 21 CFR Part 803 – Medical Device
Reporting; 21 CFR 806 – Medical Devices; Reports of Corrections and Removals.
♦ Non-Clinical Good Laboratory Practice (21 CFR Part 58)
♦ Industry Standards (ISO 9001; ISO 13485; ISO 15189)
FDA regulations require organizations to conduct and document periodic (annual) internal quality audits as an independent inspection and review of an establishment’s activities for all operations that affect quality, safety and efficacy of processes and products. Our auditors are highly trained and qualified to verify, by examination of objective evidence, the degree of compliance with those aspects of the quality management system under review.
When systemic, repetitive, or critical quality problems threaten the quality, safety, and/or efficacy of your products and/or processes, directed audits are often required to identify the root cause, or causal factors involved, and to identify appropriate remedial action(s) to address the immediate problems, as well as corrective actions to address the cause and prevent recurrence. Our consultants are qualified in risk management assessment, root cause analysis, and quality auditing to help you ensure that your systems remain in a state of control.