i. The purpose of the Gap Analysis is to evaluate the documented Quality Management System against the relevant API Q1/Q2 Specifications. It aims to assess the establishment, implementation, and effectiveness of the Quality Management System in accordance with these specifications.

ii. For API Product Monogram assessments, compliance is reviewed against the applicable API Product Specification.

iii. A Gap Analysis involves a comprehensive review where each clause of the API standard is examined for compliance. While implementation verification is part of this thorough assessment, the focus is primarily on reviewing the necessary documentation and records, typically conducted from an office or meeting setting.

iv. Our experienced auditors will evaluate your system either on-site at your facility or virtually, based on your preferences. Following this assessment, a detailed Gap Analysis report will be provided, outlining findings and recommending necessary corrections and corrective actions..

i.Internal auditing serves as an impartial and objective assurance and consulting activity aimed at enhancing an organization’s operations. Its primary goal is to contribute value and facilitate improvements in an organization’s effectiveness in managing risks, controlling processes, and governance.

ii.Organizations that have established Quality Management Systems according to API Q1/Q2 and Product Monogram standards, and are pursuing certification, are obligated to conduct internal audits at regular intervals. These audits can be performed by internal employees or outsourced to external parties.

iii.AVN Professional Quality offers expertise in planning, executing, and reporting internal audits on behalf of organizations. We provide comprehensive audit reports detailing findings and recommending necessary corrections and corrective actions..

i. A process audit is an examination of results to determine whether the activities, resources and behaviours that cause them are being managed efficiently and effectively.

ii. Process audits seek to improve selected processes by finding out how they perform against a defined criterion.

iii. Process audit will provide various benefits for identifying process system gaps and improvement of the process.

i. Product audit is an examination of a particular product or service or product monogram, such as hardware, processed material, or software, to evaluate whether it conforms to requirements (i.e., specifications, performance standards, and customer requirements).

ii. Product Audits evaluate actual product characteristics, product family, parts, or product components against a certain specification(s), which is the criteria for the audit. Product Audits seek to find out if the product meets the exact requirements of applicable specifications / standard / code. Many products can also be certified to a specification, and therefore require an audit to verify compliance, such as the case of API monogrammed products.

i. A Supplier/Vendor Audit aims to physically or on-site verify that suppliers comply with specific criteria, as defined by your organization. These criteria may include, but are not limited to:

• Evaluation/re-evaluation of Suppliers/Vendors
• Adherence to specific ISO or API standards, such as ISO 9001, API Q1, or API Q2, and product specifications
• Compliance with your organization’s specific requirements for Suppliers/Vendors
• Meeting product specifications
• Fulfilment of procurement requirements

ii. As mandated by API Specifications or the ISO 9001 Standard, a Supplier/Vendor audit is essential to ensure that the Supplier/Vendor possesses the capability to deliver products and/or services to your organization while meeting your Quality, Environmental, Safety, On-Time Delivery, or other relevant requirements..