Planning IATF 16949 Clause 6

While planning for QMS, organization shall determine issues related to Context or organization and requirement for interested parties, and determine risk and opportunities that need to be addressed. 

Planning defines requirements for addressing risks and opportunities and the requirements for risk analysis. This clause also includes requirements for preventive actions, contingency plans, and quality objectives and plans to achieve them.

Here we not only identify Risk and opportunity but also create plan for how to address them. Planning has always been a familiar element in the automotive standards, but now there is an increased focus on ensuring that it is considered with Clause 4.1 ‘Context of the organization’and Clause 4.2 ‘Interested parties’. The first part of this clause concerns risk assessment while the second part is concerned with risk treatment.

Clause 6 brings the risk base thinking to the front. If organization has identified the risk and opportunity, it needs to stipulate how these will be address through planning.

There could be risk assessment format. In response to these industry trends, IATF 16949 includes several risk-related requirements to its content. These requirements act together to improve program planning and development, reducing the likelihood of program failure and mitigating risk.

Any organization could have multiple number of action plan to reduce risk. Example- PFMEA is action plan to reduce process related risk, Safety plan to reduce risk related to health and safety, maintenance plan to reduce risk related to tool failure, etc.

When determining actions to identify risks and opportunities these need to be proportionate to the potential impact they may have on the conformity of products and services. Opportunities could include geographical expansion, new partnerships, or new technologies. The organization needs to plan actions to address both risks and opportunities, to integrate and implement the actions into its management system processes and evaluate the
effectiveness of these actions. Actions must be monitored, managed and communicated across the organization.

6.1.1 Requirement for Risk Analysis

The IATF adopted additional requirements for risk analysis recognizing the continual need to analyze and respond to risk. Organizations
would need to periodically review lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, and rework, and implement action plans in light of these lessons.

 

The organization shall retain documented information as evidence of results of risk analysis. The effectiveness of these actions should be evaluated, and actions integrated into the organization’s QMS.

The action plan which is being discussed here for lesson learned is preventive action and contingency plan.

6.1.2 Requirement for preventive action

The organization shall determine and implement the action to eliminate the cause of potential NC in order to prevent their occurrence. Preventive action shall be appropriate to the severity of potential issues.

The organization shall establish a process to minimize the impact of negative effect of risk including following:-

1. Determining potential NC and their causes.
2. Evaluating the need for action to prevent the occurrence of NC
3. Documented information of action taken
4. Reviewing the effectiveness of action taken
5. Horizontal deployment of action to prevent reoccurrence in similar process

6.1.3 Requirement for Contingency plan

The expanded requirement ensures the organization defines and prepares contingency plans along with a notification process to the
customer or other interested parties.

Contingency planning is developing responses in advance for various situations that might impact business. Although negative events probably come to mind first, a good contingency plan should also address positive events that might disrupt operations – such as a very large order.

Organizations would first take a systematic approach to identifying and evaluating risk for all manufacturing processes, giving particular attention to external risk.

A good contingency plan should include any event that might disrupt operations. Here are some specific areas to include in the plan:

• Natural disasters, such as hurricanes, fires, and earthquakes
• Crises, such as threatening employees or customers, on-the-job injuries, and worksite accidents
• Data loss, such as loss due to natural disasters, sabotage, or other criminal action (such as an attack on a website)
• Mismanagement, such as theft, neglect of critical duties, or accidental destruction
• Product issues, such as a huge order that requires reallocation of plant resources or a product recall

6.2 Requirement of Quality objective

 Another key element of this clause is the need to establish measurable quality objectives. Quality objectives now need to be consistent with the quality policy, relevant to the conformity of products and services as well as enhancing customer satisfaction.

Example of Quality objective

• Product– reduction in defect rate, PPM, scrap rates, on time delivery
• Process– Improving productivity, reduction of waste, set-up time or rework, improve cycle time
• Customer– Product return, reduction in complaints, improvement in customer satisfaction scores, improved on time delivery
• Suppliers– Reduction of complaints or defects, improved on time delivery
• Resources-Availability, capability, personnel, competency, efficiency, absenteeism.

Planning to achieve the Quality objective

The objective should be designed to be SMART (Setting objective that are specific, measurable, achievable, Realistic, and time-based)

• Specific– Clear and concise
• Measurable– If you can’t measure, how do you know that it was been achieved
• Achievable– Personnel  need to agree that the objective is achievable
• Realistic-do not set unrealistic goal
• Time-based- need to set a due by date to focus attention and to monitor achievement to your goal.

If you like this article, subscribe, follow and share using below social icons.