Why Audits Are Essential

Audits provide independent assurance that products and manufacturing processes:

• Remain consistent over time
• Comply with agreed requirements or standards
• Are supported by effective quality management systems

However, the basis of compliance depends on the certification route being followed.

Agrément & HAPAS Audits – Auditing Compliance with an Agreed Quality Plan

Surveillance audits on the manufacturers of products with Agrément or HAPAS Certification are carried out on a six-monthly basis. These audits focus on confirming that a product is being manufactured in full compliance with a Quality Plan agreed between the BBA and the manufacturer. Whilst all BBA Certified products are subject to a formal review every 3 years, these regular surveillance audits are designed to ensure that the product being manufactured remains representative of that originally assessed by the BBA and described in the relevant Certificate.

The role of the Quality Plan

The Quality Plan is a key document within the Agrément and HAPAS certification process. It defines precisely how a certified product must be manufactured and controlled, including:

• Raw materials
• Formulations
• Production processes
• Quality control procedures
• Quality management system, including complaints, calibration, training etc
• Change management processes

Once agreed, the Quality Plan becomes the reference document against which ongoing audits are conducted. The manufacturer is required to inform the BBA of any changes to the Quality Plan, and have this agreed, prior to their introduction.

What the audit covers

During an Agrément or HAPAS audit, the BBA assesses whether the manufacturer is:

• Maintaining manufacture of the product exactly as described in the Quality Plan
• Using approved raw materials
• Adhering to agreed formulations
• Following the defined production process at the agreed site of manufacture
• Recording, investigating and resolving complaints appropriately
• Maintaining relevant staff training records
• Keeping accurate and up‑to‑date documentation

Agrément and HAPAS audits therefore confirm ongoing compliance with a product‑specific, agreed BBA Quality Plan.

Factory Process Control (FPC) Audits – Auditing production control against Designated Standards

Factory Process Control (FPC) audits are distinct from Agrément and HAPAS audits in both scope and intent. Factory Process Control (FPC) is a system implemented by manufacturers to ensure products placed on the market:

• Are produced consistently
• Conform to Designated Standards or United Kingdom Assessment Documents (UKADs)
• Meet the requirements for UKCA marking

FPC focuses on the manufacturer’s production and quality systems, potentially for a range of materials covered by the relevant normative document, rather than a single certified product.

What an FPC audit assesses

An FPC audit evaluates how effectively a manufacturer controls its production processes, based on their own internal quality control, including:

• Quality management procedures
• Batch testing and inspection processes
• Schedules of quality assurance testing
• Control and traceability of raw materials
• Production line activities
• Testing facilities and records
• Document control and corrective actions

An FPC audit assesses whether these systems are robust, effective and aligned with the relevant Designated Standard or UKAD.

A successful audit will result in the issue of a Certificate of Factory Production Control, which can then be used in support of UKCA marking for a product, or range of products.

Following issue, the factory is then subject to additional surveillance audits at the frequency defined by the normative document, usually once per year.

Choosing the Right Audit Route

Both audit services provide independent assurance, but they support different routes to market.

If you hold, or are seeking to obtain Agrément or HAPAS Certification, audits confirm that your product continues to be manufactured in line with the Agreed Quality Plan.

If you are demonstrating conformity to a Designated Standard or UKAD, FPC audits assess against the requirements of the normative document.

Understanding the distinction helps manufacturers prepare more effectively, provide the right evidence, and maintain compliance with confidence.

Timelines will vary according to client requirements and the BBA scheduling system. Speak to our team for more details.