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CASE STUDY

Supplier quality audits

Creating a pre-audit coordination process across global divisions

BEPC helped define a pre-audit coordination process and shared database workflow so supplier-quality, procurement, buyer, SME, liaison, and coordinator teams could align audit requirements before execution.

Industry
Medical Devices / Pharma
Service
Supplier Quality Audits
Project type
Pre-audit coordination process design
Geography
Worldwide
Related services
Supplier Quality Audits
Creating a pre-audit coordination process across global divisions

PAF

Pre-Audit Form process established

Global

Coordination model designed across company divisions

ISO

Standards and internal requirements captured before audits

The challenge

Supplier audits required better pre-audit alignment across supplier-quality engineers, procurement, buyers, subject-matter experts, primary supplier liaisons, and BEPC pre-audit coordinators. The client needed a harmonized process that could capture requirements before auditors began execution.

Objectives

  • Generate a Pre-Audit Form process
  • Create, manage, and support the pre-audit coordination database workflow
  • Identify and train pre-audit coordinators
  • Define audit requirements across multiple company divisions

BEPC's role

BEPC helped identify customer requirements, define the Pre-Audit Form and coordination process, support the database workflow, and enable coordinator training and cross-functional readiness.

Scope & approach

Identified requirements for the Pre-Audit Form and coordination process
Executed, validated, and populated the shared coordination database
Included customer locations, sister-company suppliers, and multiple functional stakeholders
Supported process ramp-up while meeting quality, regulatory, and business-continuity needs

The process gave stakeholders a structured way to define applicable standards, internal requirements, supplier context, and audit scope before audit execution, reducing ambiguity for customer or contract auditors.

Outcomes

The pre-audit coordination process was implemented across customer organizations with trained pre-audit coordinators and the appropriate customer departments, improving readiness before supplier audits began.

Metric

Pre-audit intake

Baseline

Requirements gathered across multiple functions

Result

Pre-Audit Form process established

Change

Structured intake model

Why it matters

Clarifies standards and audit scope before execution

Metric

Coordination database

Baseline

Supplier and location information distributed across groups

Result

Shared pre-audit coordination database workflow

Change

Centralized communication path

Why it matters

Improves visibility across customer organizations

Metric

Coordinator readiness

Baseline

Process ownership needed

Result

Pre-audit coordinators identified and trained

Change

Repeatable support model

Why it matters

Supports timely and effective audit preparation

Visual evidence

Supplier audit workflow dashboard with anonymized role-based coordination data
Role-based workflow visual representing pre-audit coordination across stakeholders.
Pre-audit form readiness dashboard with anonymized supplier audit requirements
Pre-Audit Form readiness visual representing requirements capture before execution.

Trust & references

Audits used to start with scrambling. With the pre-audit form and trained coordinators BEPC helped us stand up, every division now walks into supplier audits already aligned on scope, logistics, and documentation.

Supplier Quality Program Manager - Regulated medical-device and pharma organization (name withheld)

Partners & standards

Pre-Audit FormISOcGMPMDSAPCustomer internal requirementsSupplier quality engineeringProcurement

Last reviewed: July 2026

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