Auditing IATF 16949:2016 Clause 6.0 - Planning
by Walt Prystaj
Auditing Clause 6 of IATF 16949:2016, which addresses Planning for the Quality Management System, requires verifying how an organization identifies risks and opportunities, sets quality objectives, and plans changes to its QMS. Here's a detailed guide to auditing Clause 6:
Clause 6: Planning
6.1 Actions to Address Risks and Opportunities
• Requirement: The organization must:o Determine risks and opportunities that could affect the QMS and its intended results.
o Plan actions to address these risks and opportunities.
o Integrate these actions into QMS processes.
o Evaluate the effectiveness of these actions.
Audit Approach:
o Verify the process used to identify risks and opportunities (e.g., risk assessments, FMEA, or SWOT analysis).
o Review documented evidence of risk identification (e.g., risk registers or process flowcharts).
o Assess how the organization integrates risk mitigation into its operational planning (e.g., production schedules, training plans).
o Look for evidence that actions taken to address risks and opportunities are monitored and evaluated for effectiveness.
Questions to Ask:
o How does the organization identify and prioritize risks and opportunities?
o Can you provide examples of actions taken to mitigate risks or capitalize on opportunities?
o How is the effectiveness of these actions evaluated?
Common Non-Conformances:
o No systematic approach to identifying risks and opportunities.
o Lack of documented evidence of risk assessment or action planning.
o Failure to evaluate the effectiveness of risk mitigation actions.
6.2 Quality Objectives and Planning to Achieve Them
• Requirement: Quality objectives must:
o Be consistent with the quality policy.
o Be measurable and consider applicable requirements.
o Include objectives needed to meet customer satisfaction and QMS improvement.
o Be communicated, monitored, and updated as necessary.
o Be planned, with actions, responsibilities, and timelines defined to achieve them.
Audit Approach:
o Review documented quality objectives and verify they align with the quality policy and strategic goals.
o Check whether objectives are SMART (Specific, Measurable, Achievable, Relevant, Time-bound).
o Assess the planning process to achieve these objectives, including assigned responsibilities and timelines.
o Verify if the organization tracks progress toward objectives (e.g., through KPIs, dashboards).
Questions to Ask:
o How are quality objectives determined, and who is involved in the process?
o Can you show evidence of progress toward achieving the objectives?
o How does the organization communicate quality objectives to employees?
Common Non-Conformances:
o Objectives are vague, non-measurable, or inconsistent with the quality policy.
o No evidence of planning or assigned responsibilities for achieving objectives.
o Lack of progress tracking or review of objectives.
6.3 Planning of Changes
• Requirement: When planning changes to the QMS, the organization must:
o Consider the purpose and potential consequences of changes.
o Assess resource requirements.
o Allocate or reassign responsibilities.
o Maintain the integrity of the QMS during changes.
Audit Approach:
o Verify records of planned changes (e.g., process modifications, new equipment, or system updates).
o Check if the organization evaluated risks and opportunities associated with changes.
o Assess how resource requirements and responsibilities were determined and assigned.
o Ensure there is no disruption to QMS conformity during the transition.
Questions to Ask:
o How does the organization plan for changes in the QMS?
o Can you provide an example of a recent change and the steps taken to manage it?
o How do you ensure changes do not negatively impact the QMS?
Common Non-Conformances:
o No documented process for planning changes.
o Insufficient risk analysis or resource planning before implementing changes.
o Lack of evidence showing QMS integrity was maintained during changes.
Auditor's Checklist for Clause 6
Area Audit Focus
Risk and Opportunity Management Is there a structured method for identifying and addressing risks and opportunities?
Are actions integrated into QMS processes and evaluated for effectiveness?
Quality Objectives Are objectives measurable, aligned with the quality policy, and communicated to relevant employees?
Is there evidence of planning, monitoring, and updating objectives?
Change Management Are potential impacts of changes considered before implementation?
Are responsibilities assigned, and resources allocated for managing changes?
Was the QMS integrity maintained during changes?
Interview Questions for Clause 6
1. Risk and Opportunities:
o How are risks and opportunities identified in your processes?
o What actions have you implemented to address specific risks or opportunities?
o How do you monitor the effectiveness of these actions?
2. Quality Objectives:
o How are quality objectives established, and how do they align with the quality policy?
o Can you explain how objectives are tracked and updated?
o How do you communicate objectives to ensure awareness at all levels?
3. Change Management:
o How do you plan and assess the impact of changes in your QMS or operations?
o Can you share an example of a recent change and the process followed to implement it?
o What measures do you use to ensure changes do not compromise QMS performance?
Common Findings and Recommendations
1. Findings:
o Risks and opportunities are not clearly documented or addressed.
o Objectives are generic, unmeasurable, or lack actionable plans.
o Changes are implemented without formal planning or risk assessment.
2. Recommendations:
o Develop a structured risk management framework (e.g., FMEA, SWOT).
o Ensure objectives are SMART and linked to customer and QMS requirements.
o Formalize a change management process, including documentation, risk evaluation, and communication.
Auditing Clause 6 thoroughly ensures the organization has robust planning mechanisms that support QMS effectiveness and continuous improvement.
