Auditing IATF 16949:2016 Clause 8.0 - Operation

by Walt Prystaj

 

Auditing Clause 8 of IATF 16949:2016, which addresses Operation, is crucial as it encompasses all activities related to the planning, control, and execution of product and service delivery. Below is a detailed guide to auditing Clause 8.

Clause 8: Operation

8.1 Operational Planning and Control

• Requirement:

o The organization must plan, implement, and control processes needed to meet requirements for product and service provision.
o This includes addressing risks, opportunities, customer requirements, and continual improvement.

Audit Approach:

o Review how the organization plans operations, ensuring it considers risks, opportunities, and customer requirements.
o Verify controls are in place for process consistency and compliance.
o Check evidence of continual improvement efforts in operations.

Questions to Ask:

o How do you plan and control operations to meet customer requirements?
o What tools or methods are used to assess and mitigate risks in operations?

Common Non-Conformances:

o Lack of defined controls for key processes.
o Failure to integrate risk-based thinking into operational planning.

8.2 Requirements for Products and Services

• 8.2.1 Customer Communication:

o Organizations must establish methods for communicating with customers regarding product information, inquiries, contracts, feedback, and complaints.

Audit Approach:

o Check communication records, such as emails, meeting minutes, and customer feedback logs.
o Verify that complaints and inquiries are tracked and resolved effectively.

8.2.2 Determining Requirements for Products and Services:

o Ensure requirements, including those not stated by the customer but necessary for use, are determined.

Audit Approach:

o Review customer contracts and specifications to verify all requirements are identified and documented.
o Check whether customer-specific requirements (CSRs) are addressed.

8.2.3 Review of Requirements:

o The organization must review requirements before committing to supply.

Audit Approach:

o Verify contract review processes to ensure feasibility and compliance.
o Check records of review activities for completeness.

Common Non-Conformances:

o Inadequate review of customer requirements leading to non-conformance.
o Poor communication regarding changes in requirements.

8.3 Design and Development of Products and Services

• Requirement:

o If applicable, the organization must establish, implement, and maintain a design and development process.

Audit Approach:

o Verify the design process stages are clearly defined, including planning, inputs, outputs, and reviews.
o Check evidence of risk analysis, such as DFMEA.
o Ensure design validation and verification activities are performed.

Questions to Ask:

o How are design inputs determined and reviewed for adequacy?
o What methods are used for design validation and verification?

Common Non-Conformances:

o Missing or incomplete design reviews.
o Insufficient validation or verification activities.

8.4 Control of Externally Provided Processes, Products, and Services

• Requirement:

o The organization must ensure that externally provided processes, products, and services conform to requirements.

Audit Approach:

o Review supplier approval and monitoring processes.
o Verify records of supplier evaluations and re-evaluations.
o Check purchase orders and contracts for clear requirements.

Questions to Ask:

o How do you ensure suppliers meet quality and delivery requirements?
o What criteria are used to evaluate supplier performance?

Common Non-Conformances:

o Lack of documented supplier approval processes.
o Inadequate monitoring of supplier performance.

8.5 Production and Service Provision

• 8.5.1 Control of Production and Service Provision:

o Organizations must implement controlled conditions for production and service provision.

Audit Approach:

o Observe production areas to ensure compliance with documented processes.
o Verify the use of work instructions, process parameters, and monitoring activities.
8.5.2 Identification and Traceability:

o Products must be identifiable and traceable through all stages of production.

Audit Approach:

o Check product labeling, traceability logs, and lot control records.
o Verify compliance with customer traceability requirements.

8.5.3 Property Belonging to Customers or External Providers:

o Customer property must be identified, protected, and maintained.

Audit Approach:

o Inspect records of customer property and verify handling practices.

8.5.4 Preservation:

o Products must be preserved during internal processing and delivery.
Audit Approach:

o Verify storage, handling, and packaging practices to prevent damage.

8.5.5 Post-Delivery Activities:

o Post-delivery activities must meet customer and statutory requirements.
Audit Approach:
o Check procedures for handling warranty claims, maintenance, or returns.
Common Non-Conformances:
o Lack of clear traceability for products.
o Inadequate handling of customer property or post-delivery issues.

8.6 Release of Products and Services

• Requirement:

o Products must be inspected or verified to meet requirements before delivery.

Audit Approach:

o Review inspection records and release documentation.
o Verify that non-conforming products are not released.

Questions to Ask:

o How do you verify products meet customer requirements before shipment?
o What steps are taken when products fail inspections?

Common Non-Conformances:

o Missing or incomplete inspection records.
o Unauthorized release of non-conforming products.

8.7 Control of Nonconforming Outputs

• Requirement:

o Nonconforming outputs must be identified, controlled, and prevented from unintended use.

Audit Approach:

o Review non-conformance records, corrective actions, and disposal processes.
o Inspect quarantine areas to ensure proper segregation.

Questions to Ask:

o What is the process for identifying and managing non-conforming outputs?
o How are corrective actions tracked and reviewed for effectiveness?

Common Non-Conformances:

o Inadequate segregation or identification of non-conforming outputs.
o Lack of follow-up on corrective actions.

Auditor's Checklist for Clause 8

Area Audit Focus

Operational Planning Are operations planned with risk-based thinking and aligned with customer requirements?
Requirements Are customer requirements reviewed, communicated, and fulfilled effectively?
Design and Development Is the design process adequately planned, verified, and validated?
Supplier Control Are suppliers evaluated and monitored to meet requirements?
Production Control Are controlled conditions in place for production and service provision?
Product Traceability Is traceability maintained, and customer property properly handled?
Non-Conformances Are non-conforming outputs controlled and corrective actions implemented effectively?

Common Findings and Recommendations

1. Findings:

o Missing risk assessments in operational planning.
o Poor documentation of customer requirement reviews.
o Insufficient monitoring of supplier performance.
o Inadequate control of non-conforming products.

2. Recommendations:

o Develop and implement a risk-based approach to operational planning.
o Enhance supplier evaluation processes with clear performance metrics.
o Train staff on non-conformance handling and corrective actions.
o Regularly review customer feedback to improve operations.

Auditing Clause 8 thoroughly ensures that the organization’s operational processes are robust, customer-focused, and effective in delivering quality products and services.