Leadership

5.1.1 General

The idea of “leadership” is key to the early adoption and understanding of the ISO 9001:2015 standard. Leadership is different from management commitment because it implies a deeper level of engagement, rather than simply “committing passively.” Leadership implies the management for a facility must actively steer and engage, and in effect “go first,” as in be the first one to move toward quality. The sort of decisions the leadership of a company makes will have a direct impact on all resource allocation and subsequent decisions that will be made by the organization.

What is it?

• Provides a general “expectation” that requires top management to be present at the front and to lead the effort in QMS adoption and administration
• Provides a structure that links performance of the QMS with accountability at the highest level
• Gives structure to the “ownership” of a process from the Turtle diagram or other process exploration activity
• Calls on the top management to be the steward of the risk-based thinking presented and further refined in the planning aspects of a business
• Forces the top management in the organization to be engaged in terms of real commitment

How do I do it?

1. Identify the leadership present in each process in your organization
2. Familiarize the leadership with the metrics they chose for the performance of the processes they oversee
3. Add process metrics to the Management Review
4. Tie improvement programs to those metrics where applicable and beneficial

Tools and techniques to achieve it

• KPI (Key Performance Indicator) identification
• Organizational construction
• Mentorship programs
• Continued education for management

Documents you can use to prove it

• Job descriptions
• Management Reviews
• KPIs loaded into metric dashboards
• Organization charts

Questions to ensure you know it

• Does every process on our interaction map have an owner?
• What is the reaction plan if one department manager gets overwhelmed?
• How do we ensure that our process needs are captured during strategic planning for the next year?
• How do we know which of our KPIs are critical, and did we set limits for them so there is a warning before catastrophic failure?
• How will we know if the new message regarding quality is adopted by the employees working on the factory floor? What would be our proof?
• How do we communicate what is important about the quality of the products or services we provide?

How can you fail at it?

• You don’t publicize the commitment
• You don’t honor the small commitments that were made public
• You don’t act with integrity in alignment with the Quality Policy
• You don’t identify all roles and contingencies

5.1.2 Customer Focus

As top management grows and becomes entrenched in the business, it is imperative that the focus on the customer is not lost in the need to reduce cost, shrink lead times, and manage inventory. This focus must be built from the top down (the leaders) if the perspective of the employees is to be adjusted and molded into that of a high-performance organization.

What is it?

• Establishes metrics that drive your customers’ needs for products and services
• Measures those metrics as the customer would measure the metrics
• Utilizes the customers’ perceptions of your service or product in your analysis of your organization’s performance
• Balances the financial performance of the system against the customers’ expectations of the system to ensure you can deliver according to the agreement

How do I do it?

1. Determine customer needs
2. Utilize the interactions map you generated in Section 4 to determine which processes support this goal toward understanding customer needs
3. Check the goals set for the facility against the expectations of the customer versus the expectations of your own organization
4. Modify the goal or negotiate a middle ground if the goal is not achievable
5. When moving throughout the organization, sell the metric through the vocabulary that customers will use to align with their thinking

Tools and techniques to achieve it

• Surveys
• Review the customer’s quality documentation to understand your role as the external provider
• Review the terms and conditions set forth in the contract
• For roles that impact the customer’s perception, assign responsibility as a customer rep inside the job descriptions of appropriate associates

Documents you can use to prove it

• Management Review
• Contract terms
• Corrective action processes
• Job descriptions
• Organizational charts
• Customer surveys performed

Questions to ensure you know it

• How do we know we are meeting our customers’ milestones in the new product launch?
• How do we know we are meeting the customers’ contractual requirements?
• If a customer has an issue, whom do they contact?
• How do we prove to customers that we have considered their need for corrective action turnaround time in the setting of our own goals?
• How do we know that the customer’s defect rating for nonconforming parts is going to be met through our target?

How can you fail at it?

• You don’t identify targets based on mutually beneficial customer targets
• You don’t act with integrity in your communications with the customer
• You don’t act in the best interest for the various stakeholders and it results in harm or loss

5.2 Policy

Once top management knows in what direction they are going, and how they wish to move, they have to communicate it to the rest of the employees in the company. This is where the QUALITY POLICY comes in, and is the guiding document for all the coordinated activities that will eventually be in progress.

What is it?

• A guide to drive decisions in the organization as the suitability of these decisions will be determined by how they are defined in the Quality Policy
• Provides a framework to show “what is important” to the organization
• Reinforces the continual improvement aspect of the business
• Provides further commitment from the organization that it will satisfy all applicable requirements

How do I do it?

1. Management determines the appropriate format and tone of the Quality Policy based on the company’s culture
2. Draft a copy and revise it accordingly until the tone and the format match the needs of the business and the product it makes
3. Check to ensure it provides a broad framework, and it includes a statement to commit to all applicable requirements and to continually improve
4. Add the Quality Policy to the cornerstone documentation for your QMS right next to your business and mission statement.

Tools and techniques to achieve it

• Brainstorming
• Affinity diagrams
• Balanced Scorecard methodology
• Strategic off-site planning meetings

Documents you can use to prove it

• The Quality Policy (it is required documented information)

Questions to ensure you know it

• How does the Quality Policy affect our strategic and operational spending in the coming year?
• How have we measured up so far to the “ideas” we put in the policy over the last 12 months?
• How do we know that we are complying with our applicable requirements?
• How can we show we have continually improved the QMS?
• How did we establish who needs to know the Quality Policy?
• How do we utilize the Quality Policy outside of our organization?

How can you fail at it?

• You don’t align the Quality Policy with context
• You don’t make improvement part of the policy
• You don’t explain to everyone in the company what the Quality Policy means for them
• You don’t distribute the policy and the information broadly enough to be fully recognized by everyone that needs to know about it

5.3 Organizational Roles, Responsibilities and Authorities

Once you have an idea of what you want to do, how you want to structure that, and how you will lead your organization in the field, you’ll need to establish roles and responsibilities so everyone knows who is responsible for what within the QMS.

What is it?

• Roles must be assigned, communicated and understood
• These roles must spell out both the responsibility and authority for people in the organization
• Everyone with assigned roles must have defined responsibilities that include ensuring the QMS is functioning as intended
• Changes and alternatives must be established to maintain continuity in the face of change
• Opportunities for improvement need to come from some of these roles (Section 10.1)

How do I do it?

1. Make sure each process has an owner
2. Make sure that process owners have both authority and responsibility for the processes under their supervision
3. Make sure that for key positions, there are alternative or contingency plans and authorities in place

Tools and techniques to achieve it

• Contingency planning
• Job-needs analysis
• Strategic planning activities

Documents you can use to prove it

• Organizational chart
• Contingency or emergency plans
• Job description forms

Questions to ensure you know it

• If tomorrow we lost someone in a key purchasing position, how would our company ensure that releases of raw material for the product are continued?
• Do we have spending and approval limits for key positions that have an impact on customer satisfaction?
• Who is responsible for translation of the training text?
• If we add another outsourced process such as plating, who has the authority to add this operation to our process and interaction map?
• Who has authority to stop the line in the event of a serious quality or safety issue? And how does this get communicated to upper management in the organization?

How can you fail at it?

• You don’t align roles and responsibilities with process outcomes
• You don’t align roles and responsibilities to key or critical functions
• You don’t align roles and responsibilities with contingency and/or emergency plans