API Q1/Q2 Auditing in India

The purpose of the Gap Analysis is to assess documented Quality Management System against applicable Specification API Q1 / Q2 and provide the status of establishment, implementation and effectiveness of the Quality Management System complying to applicable specifications.

API Product Monogram is assessed against applicable API Product Specification.

A Gap Analysis is an exhaustive exercise, in which every clause of the API standard is checked for its compliance. While a thorough Gap Analysis includes verification of implementation, it is highly focused on reviewing required documentation and records– usually performed from a desk or meeting room.

Our experience auditors will assess the system by visiting your facility and / or virtually as per your expectations and provide detail gap analysis report with finding along with recommended corrections & corrective actions.

Internal auditing is an independent, objective assurance and consulting activity designed to add value to and improve an organization’s operations. It may help an organization accomplish its objectives by bringing a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control and governance processes.

Organizations who established Quality Management System to API Q1 / Q2 and Product monogram and in the process of certification, are required to conduct internal audits at periodic intervals. Internal audits can be conducted by employees internal to the organization, however, they can also be “outsourced”.

AVN Professional Quality can assist in planning, conducting and reporting internal audit on behalf of organisation and provide detail audit report with finding along with recommended corrections & corrective actions.

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

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

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

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).

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.

A Supplier/Vendor Audit seeks to verify physically or on-site at the supplier’s premises, that they are complying with certain criteria. These criteria can be dictated by your organization and may encompass the following but not limited to:

• Suppliers’ / Vendor’s evaluation / re-evaluation
• A specific ISO or API standard, such as ISO 9001, API Q1 or API Q2 and / product specification
• Your organization’s own requirements for Suppliers/Vendors
• Product specification
• Procurement requirements

As required by API Specifications / ISO 9001 Standard, a Supplier/Vendor audit should provide certainty that the Supplier/Vendor has the capability to provide products and/or services to your organization, that meet your own Quality, Environmental, Safety, On-Time Delivery, or other requirements as applicable.

AVN Professional Quality has expertise to assist your organisation to assess suppliers / vendors system and provide detail report on Supplier’s / Vendors evaluation/ re-evaluation and capability to provide products and/or services to your organization.