Auditing IATF 16949:2016 Clause 7.0 - Support
by Walt Prystaj
Auditing Clause 7 of IATF 16949:2016, which addresses Support, involves evaluating the resources, competence, awareness, communication, and documented information necessary for the effective operation of the Quality Management System (QMS). Below is a detailed guide to auditing Clause 7:
Clause 7: Support
7.1 Resources
• 7.1.1 General:
o The organization must determine and provide the necessary resources to implement and maintain the QMS.
Audit Approach:
o Review how the organization determines resource needs (e.g., for equipment, personnel, or infrastructure).
o Verify whether sufficient resources are available to meet customer and QMS requirements.
• 7.1.2 People:
o Ensure the organization has adequate personnel with the necessary skills to operate the QMS.
Audit Approach:
o Check employee availability in critical roles and assess workload management.
o Review evidence of resource planning (e.g., hiring plans or training records).
• 7.1.3 Infrastructure:
o Infrastructure includes buildings, equipment, utilities, and IT systems.
Audit Approach:
o Inspect records of maintenance schedules, upgrades, and inspections.
o Confirm that infrastructure supports QMS and operational needs.
• 7.1.4 Environment for the Operation of Processes:
o The organization must provide a suitable environment for process operations, including social, physical, and psychological factors.
Audit Approach:
o Observe working conditions and verify adherence to environmental requirements.
o Review any risk assessments related to workplace conditions.
• 7.1.5 Monitoring and Measuring Resources:
o Ensure measuring equipment is suitable, calibrated, and verified to ensure valid results.
Audit Approach:
o Review calibration records and procedures.
o Inspect sample equipment for calibration status labels or logs.
• 7.1.6 Organizational Knowledge:
o The organization must determine and maintain the knowledge necessary for effective QMS operation.
Audit Approach:
o Review documented organizational knowledge, such as procedures, best practices, or lessons learned.
o Check how knowledge is shared and updated across the organization.
7.2 Competence
• Requirement:
o The organization must ensure employees are competent based on education, training, skills, and experience.
Audit Approach:
o Review training records, certificates, and employee qualifications.
o Verify how the organization identifies training needs and evaluates the effectiveness of training.
o Interview employees to confirm they understand their roles and responsibilities.
Questions to Ask:
o What processes are in place to determine the training needs for your role?
o How does the organization assess the effectiveness of training programs?
7.3 Awareness
• Requirement:
o Employees must be aware of:
The quality policy.
Relevant QMS objectives.
Their contributions to the QMS and implications of non-conformance.
Audit Approach:
o Interview employees at various levels to assess their understanding of the quality policy and objectives.
o Verify the methods used to communicate awareness, such as meetings, emails, or posters.
Questions to Ask:
o Can you explain how your work contributes to achieving quality objectives?
o What are the consequences of not meeting QMS requirements in your role?
7.4 Communication
• Requirement:
o The organization must determine internal and external communication processes, including what, when, with whom, and how communication is conducted.
Audit Approach:
o Review documented communication plans or procedures.
o Verify how communication flows between departments and with external parties.
o Assess how customer-specific requirements are communicated internally.
Questions to Ask:
o How are quality-related changes communicated within the organization?
o How do you communicate with external customers or suppliers about quality issues?
7.5 Documented Information
• 7.5.1 General:
o The organization must maintain documented information required by the QMS and standard.
• 7.5.2 Creating and Updating:
o Documented information must be appropriately identified, reviewed, and approved.
Audit Approach:
o Check procedures for creating, reviewing, and approving documents.
o Verify that documents are controlled and updated as necessary.
• 7.5.3 Control of Documented Information:
o Documented information must be available, protected, and properly controlled.
Audit Approach:
o Review access controls and distribution methods for documented information.
o Verify that obsolete documents are identified and removed from circulation.
o Confirm retention periods and storage conditions align with organizational and customer-specific requirements.
Questions to Ask:
o How do you ensure that employees use the most current version of procedures or work instructions?
o What is the process for updating and controlling documents?
Auditor's Checklist for Clause 7
Area Audit Focus
Resources Are resources (people, infrastructure, equipment) adequate to meet QMS and customer requirements?
Is there a system to manage and calibrate monitoring and measuring equipment?
Competence Are training and qualifications documented and evaluated for effectiveness?
Awareness Are employees aware of the quality policy, objectives, and their role in the QMS?
Communication Are communication processes defined and effectively implemented for internal and external parties?
Documented Information Is documented information controlled, updated, and available as needed?
Common Non-Conformances
1. Resources:
o Insufficient infrastructure or lack of maintenance records.
o Monitoring and measuring equipment not calibrated or labeled correctly.
2. Competence:
o Missing or outdated training records.
o No evaluation of training effectiveness.
3. Awareness:
o Employees unaware of quality objectives or their relevance to their work.
4. Communication:
o Undefined or ineffective communication processes.
5. Documented Information:
o Obsolete documents in use or lack of access controls for sensitive information.
Recommendations for Improvement
• Resources: Establish a preventive maintenance schedule and conduct periodic reviews of calibration records.
• Competence: Implement a structured training matrix and regular competency evaluations.
• Awareness: Use visual aids, meetings, and workshops to reinforce awareness of the quality policy and objectives.
• Communication: Formalize a communication plan and periodically review its effectiveness.
• Documented Information: Ensure a robust document control system to manage access, updates, and distribution.
Auditing Clause 7 thoroughly ensures that an organization has the necessary support mechanisms to sustain an effective QMS and meet IATF 16949:2016 requirements.
