6.2 Quality Objectives and Planning to Achieve Them [ISO 9001 Template]

When Do I Communicate The Quality Objectives?

Certification auditors expect to see a documented plan or roadmap for communicating and meeting the quality objectives. The auditors will also determine whether the objectives meet the policy's intent and are understood by interviewing personnel at various levels.

Inferred awareness through knowledge of the quality objectives is considered insufficient. If the personnel interviewed do not know their measurable objectives and/or do not know the organizational quality objectives they directly affect, the auditor would be further directed to evaluate Top management’s methods of communicating quality objectives.

Quality objectives must be communicated at the relevant levels within the organization to ensure that teams and individuals are aware of their importance and contribution.

The communication of quality information, including quality policy and quality objectives, is often delivered via:

• Text (e.g., newsletter, email)
• Visual media (e.g., posters, short videos)
• Crew or team briefings
• Intranet websites
• Other means, as appropriate, depending on the size and complexity of the organization

When communicating the quality objectives to your employees, link the objectives to the actual quality improvements sought by the business to give staff something tangible to work towards.

Communication with personnel also provides relevant, up-to-date information about quality objectives, management activities, and critical quality information. This information should be retained as part of the management system’s data.

How Do I Achieve The Quality Objectives 6.2.2?

How Do I Establish An Action Plan For Each Objective?

Organizations must maintain documented information when establishing action plans to achieve their quality objectives.

When planning how to achieve its quality objectives, organizations must first determine:

1. What will be done
2. What resources will be required
3. Who will be responsible
4. When will it be completed
5. How will the results be evaluated? Include indicators for monitoring progress toward achievement of measurable quality objectives (see clause 9.1.1)

Organizations should consider how actions to achieve their quality objectives can be integrated into their business processes by getting the different parts of the organization to understand how they each contribute to meeting the quality objective.

This ensures that all process owners who impact the quality objective know what their role is, what they need to do, and when they should do it. For example:

• For on-time delivery to customers, the Purchasing team might have an action item to renegotiate delivery schedules
• The Maintenance team might have an action item to implement an improved maintenance schedule to address excessive equipment downtime
• Operations might take action to complete cross-training of employees to prevent work stoppages when key employees are on leave

Establishing an action plan for each quality objective may require considerable effort from the personnel at relevant levels within your organization. To ensure the progress of the action plan and a coordinated effort, a target leader should be selected for each target.

Once the action plan is established, you must implement it. You may find that the following suggestions will help foster a cooperative effort in accomplishing the plan:

• Involve your employees early in establishing and carrying out the action plans
• Communicate the expectations and responsibilities laid out in the action plans to those who need to know
• Build on the plans and programs you have now for quality management system compliance
• Keep it simple
• Focus on continual improvement of management programs over time

The quality management program should be revised regularly to reflect changes in your organization’s objectives and targets. Track all new or modified operations, activities, and/or products in case the management program needs to be amended to reflect these changes.

The methods used to evaluate the achievement of objectives might include: periodic performance comparison against established targets or expectations during management review, functional reviews, process reviews, departmental reviews, personal development reviews (appraisals), and team meetings.

How Do I Develop An Objectives Management Program?

Organizations must establish and maintain one or more management programs to achieve their objectives. Capture how each quality objective will be achieved by assigning a management program to each objective.

The management improvement program is a key element to the success of the quality management system. Properly designed and implemented, management programs will help achieve the objectives and, consequently, improve your organization’s performance in the long term.

The management program must:

1. Address each objective and target;
2. Designate the personnel responsible for achieving targets at each relevant function/level of the organization;
3. Provide an action plan describing how each target will be achieved;
4. Establish a time frame or a schedule for achieving each target.

The programs are completed and documented logically, with objectives, targets, and tasks building upon each other to reach all the identified objectives and targets. The objectives, targets, and programs are documented and retained.

How Do I Provide Evidence Of Planning?

You should seek and record evidence that effective planning was undertaken to support the organization’s quality objectives and achievement.

For each quality objective and target, one or more tasks provide a step-by-step description of how the objective and target will be achieved.

• The objectives, targets, and programs are documented
• Each quality management plan designates the responsible position or authority for each task listed
• Timescales for achieving objectives are documented, e.g., stepped achievement (weekly, monthly, quarterly), specific milestones (defined dates or periods), and annual achievement
• Relevant functions and levels of the organization necessary to complete tasks are addressed
• Responsibility for achieving objectives at the various levels within the organization, e.g., top management, functional leadership, department leadership, process owners, teams, and individuals
• Methods used to evaluate the results, e.g., periodic performance comparison against established targets or expectations during management review, functional reviews, process councils, departmental reviews, personal development reviews (appraisals), and team meetings

You should ensure that the planning activity takes into consideration Clause 6.2.1, as well as the following points:

• Identification of processes, resources, and skills needed to achieve quality
• Identification of suitable verification criteria at appropriate stages
• Compatibility of design, production, inspection, and testing
• The confirmation of the criteria of acceptability for all features and requirements
• Details of calibration of any special measuring or test equipment to be used

Do I Need To Document The Quality Objectives?

Your organization must set objectives for relevant functions, levels, and processes within its QMS. Your organization must decide which functions, levels, and processes are relevant.

We recommend you document your objectives using a description or matrix. In addition, it provides a time frame for achieving the objectives and sets out indicators to monitor the achievement of the objectives.

Indicators are defined as a measurable representation of the status of operations, management, or conditions. Each objective will need one or more associated performance indicators.

Maintain documented information to demonstrate that the quality objectives are:

• Consistent with the quality policy (Refer to ISO 9001:2015 - 2.1) to ensure that they underpin the strategic direction of the organization, support the needs and expectations of interested parties, and enhance customer satisfaction
• Aligned to applicable requirements, e.g., those defined by the organization, customer, or regulator, and relevant to the conformity of products and services
• Monitored using suitable means to ensure that the quality objectives are being met, e.g., Business Plan Deployment (BPD) charts, dashboards, matrices, reports, progress charts, traffic light charts, management review, etc.
• Communicated at the relevant levels within your organization to ensure that teams and individuals are aware of their importance and contribution
• Updated accordingly to demonstrate progress and to consider changing circumstances that could result in new, expanded, amended, cancelled quality objectives etc.

Documented information on objectives typically includes a description or matrix of the quality objective and the corresponding means and timeframe to achieve it.

How Do I Audit The Quality Objectives?

Any internal audit of your organization’s QMS should include a review of current internal performance against quality objectives, KPIs, and targets, including continual improvement activities and associated corrective action or management review records.

Verify that your organization’s overall quality objectives:

1. Have been defined
2. Reflect the quality policy
3. Have been translated into goals and indicators
4. Are substantially coherent
5. Are aligned and compatible with the organization’s context and strategic direction
6. Are aligned with its overall business objectives, including customer expectations

If this is not the case, you should evaluate Top management’s commitment to quality. The quality objectives must be measurable and verifiable, but not necessarily quantified. Qualitative results may also be relevant, e.g., a ‘yes or no’ answer regarding achieving quality objectives is acceptable, providing evidence can support it.

There is no specified way of identifying or documenting quality objectives, as these may be present in business plans, management review outputs, annual budgets, etc. Internal auditors should satisfy themselves that the objectives are adequately documented.

You should obtain evidence of how the quality objectives are suitably cascaded throughout your organization’s structure and processes, linking the general strategic objectives to management objectives and specific operational activities.

You should also ensure that the quality objectives are realistic and relevant and that your organization has assigned responsible people the resources needed to meet their objectives. Evidence of this should be obtained throughout all levels of your organization.

Quality objectives are not static and need to be updated in the light of the current business climate and the quest for continual improvement. Internal auditors should verify that your organization's overall performance reflects the aims of the quality policy and reasonably meets the quality objectives.

How Do I Establish The Performance Indicators?

A key addition in the 2015 revision is using performance indicators to monitor your processes and their effective operation, and to achieve the quality objectives. (Refer to ISO 9001:2015 - 4.4.1c). Each quality objective may require one or more associated indicators to provide enough detail about its performance.

Quality management system performance indicators are defined as a measurable representation of the status of operations, management, or conditions. Each objective may require one or more associated quality performance indicators and target.

Performance indicators are generally data-based expressions of the frequency of occurrence of events, incidents, or reports. These performance targets are measured and monitored in conjunction with performance indicators, expressed in ratios, averages, moving averages, rates, or trends as appropriate.

The standard requires your organization to determine and apply the criteria and methods to ensure effective operation and control of the identified processes. Such criteria and methods might include, for example, process monitoring indicators, process performance indicators, target setting, data collection, performance trends, or internal/external audit results. Other criteria and methods might include:

• Arrangements for governing each process, e.g., process owner reviews, process committees, flight deck/dashboard representations, risks and opportunities relating to the process, resource needs, user training/competency, continual improvement initiatives, frequency of reviews, agenda, minutes, actions
• The organizational approach towards continual improvement and the types of action taken when process performance is not meeting intended results
• Identifying ‘what' needs to be monitored and measured to determine QMS and process performance, e.g., Internal - achievement of quality objectives, process performance indicators, target setting, audit results (conformity/nonconformity, effectiveness), trends. External - customer and supplier performance, e.g., survey results, satisfaction indicators/ratings, compliments, complaint profile, returns/rejections, warranty claims, invoice queries

Objective evidence should indicate that your organization has successfully integrated the QMS processes into its business processes. Evidence may include top management reviewing QMS KPIs as part of regular business reviews, awareness of contractors and employees of QMS goals and expectations, etc.

Depending on your organization's size, management structure, and other factors, the quality objectives may be established and reviewed by various personnel and with direct Top management input. The objectives, performance indicators, and targets must be consistent with quality policy and business strategy.

How Do I Link The Performance Indicators To The Objectives?

The performance indicators must link to and support the relevant quality management system objectives. Performance indicators need to be simple, measurable, and reliable. The KPIs include a mix of outcome indicators (e.g., nonconformity rates, % audit success, open/closed status of risk assessments) and process indicators (e.g., validation of quality critical processes, and record keeping).

Performance assessment results are used in two ways:

1. To measure the effectiveness of risk mitigation measures by comparing KPIs to targets set in the quality objectives statement
2. To identify potentially new risks resulting from ineffective mitigations

A hierarchy of quality targets is formed, from strategic objectives (e.g., to minimise adverse effects), through to operational and more detailed functional objectives (e.g., to increase levels of quality training by a stated amount), to specific performance criteria (e.g., reducing occupational exposure limits or lost-time incidents).

You could create an Excel workbook with tabs for defining the quality objective, an action plan, and the actual data. Stay on top of it with regular updates and reviews to ensure actions are completed to drive improvement. You should consider and implement the following to help ensure compliance with ISO 9001:2015 -  6.2:

• Ensure that quality objectives are established within the relevant functions (Engineering, Purchasing, Finance, Human Resources, Quality, IT, etc.), and are linked to the respective functional strategy, e.g., functional direction, process improvement, milestones etc.
• Ensure that quality objectives are established within relevant processes, which are defined by the process owner relating to the aims of the process, e.g., what the process is trying to achieve, resources needed, timescales etc.
• Ensure that quality objectives are established and suitably cascaded across your organization's structure, e.g., Top management, middle management, supervisors, departments, projects, groups, and individuals

The table below shows the quality objectives and provides ideas for performance indicators and ideas for targets that, in turn, may be used to measure the achievement of each quality objective.

The table also provides ideas for KPIs and targets that, in turn, may be used to measure the achievement of each objective.

How Do I Audit The Performance Indicators?

Use of the process approach by your organization to identify sources of input, activities, output, receiver of output, performance indicators to control and monitor processes, the risks and opportunities associated with them, and an action plan to address them.

The use of indicators needs to be audited in detail:

• Are quality objectives and subsequent indicators based on sound information?
• Are indicators really related to the corresponding quality objectives?
• Are statistical tools needed to define and monitor quality objectives?
• If the indicators reach expected values, how does your organization ensure the quality objective has been achieved?

Your organization should audit the performance indicators in detail to establish whether the quality objectives are based on sound information and whether the indicators and targets are related to the corresponding objectives. Ensure your organization uses statistical tools to define and monitor the quality objectives.

Certification Auditors will expect to review a set of interrelated objectives, ensuring that they are mutually consistent and aligned with your organization's strategic direction.

Often, Certification Auditors will interview members of Top management to determine whether your organization has established and ensured the continued relevance of its quality policy, related quality objectives, indicators, and targets, as well as how performance measures are established, whether they are aligned to your organization’s context, and the requirements of your interested parties.

The objective of Key Performance Indicators (KPIs) is to provide a transparent and comprehensive framework for process control through regular quality assessments of the nonconformance process to evaluate whether the process is running according to expectations in terms of quality, time, and costs, and if changes to the process are required.

What Types Of Performance Indicators Are There?

An organization’s quality management system performance is verified by reference to leading and lagging performance indicators and performance targets linked to our activities, as set by our quality management system in support of our quality objectives.

Leading indicators, which are particularly relevant from a management perspective, may influence management priorities and determine actions for improvement. Leading indicators (proactive) are measured without a nonconformance occurring and help predict or prevent future events linked to processes and activities. Leading indicators that are used include the following:

• Frequency and status of quality audits
• Culture and behaviour
• Attitude and opinion surveys
• Training provided against programs
• Investigations closed within 14 days
• Frequency and status of workplace inspections

Lagging indicators are measures of occurrences, particularly the adverse outcomes that the organization aims to prevent. Lagging indicators are mainly used for aggregate, long-term trending, either at a high level or for specific occurrence types or locations.

Lagging indicators (reactive) are those that show the number and or severity of events that have occurred:

• Lost time incidents
• Nonconformances
• Days lost
• Procedural deviations
• Lower-level system failures and safety events
• Absence data
• Property damage

Performance indicators are intended to be easy to measure and monitor, and relevant to the organisation or workgroup whose performance is being measured, to provide an immediate and reliable indication of the level of performance.

Organizations should ensure that quality performance indicators:

• They are under the control of individuals performing the process
• They are positive and easily understood
• They are relatively easy to monitor
• Consists of a large volume of data that can be fed back
• Reflect on current situations, not historic ones

Performance indicators are understood and owned by the organization or workgroup whose performance is being measured, whilst being cost-efficient in equipment, personnel, and additional technology required to gather performance information.

What Are Performance Targets?

Targets define long-term quality management system performance objectives. They are expressed numerically and must be concrete, measurable, acceptable, reliable, and relevant.

Targets also contain completion dates with milestones if the target is to be achieved in phases or over an extended period. Targets provide a measurable way of ensuring and demonstrating the effectiveness of quality performance objectives.

Targets are based on performance criteria that describe the standards or limits to which a particular activity or system element is to perform. These apply at various levels within our quality management system. Such criteria may establish the nature and frequency of such tasks as:

• Plant maintenance
• Quality management system reviews and audits
• Assessment of training needs
• Hazard and effects identification and risk assessment
• Testing of emergency plans
• Testing emergency shut-down and prevention systems
• Testing fire detection, protection, and alarm systems
• Process and emission monitoring

As the basis for control, monitoring, and performance measurement, criteria are readily measurable and clearly and unambiguously documented.

Can I See Examples Of Key Performance Indicators?

The examples of key performance indicators listed below reflect specific and quantifiable measures that your organization can use to evaluate the quality of the process, ensure ongoing optimization, and process design improvements.

KPIs can be reported quarterly or monthly; however, Top management may require more frequent reporting of metrics and KPIs as necessary. The following performance indicators should be measured over a specific time period, e.g., quarterly, etc.:

The following table provides examples of metrics related to nonconformances. There is no obligation to apply all examples; each organization can define its KPIs and metrics.

How are Quality Objectives Monitored & Revised?

The performance of our organization is measured, including performance indicators and targets linked to our quality management system objectives. The performance of our organization is measured, and the KPIs are continuously monitored and analyzed for trends.

KPIs demonstrate the performance of our organization and the effectiveness of risk controls based on reliable data. KPIs are reviewed and regularly updated to ensure they remain relevant when:

• An indicator shows that risk control is not adequate
• Defining KPIs and targets appropriate to your organization’s activities, risks, aspects, and objectives
• Reviewing whether action has been taken when a KPI shows a negative trend (which may reflect an ineffective risk control or an inappropriate KPI)
• The results of quality performance monitoring are discussed at Top management’s level
• Evidence of feedback provided to the Quality Manager is analyzed and reported

Quality objectives should be monitored using suitable means to ensure that the objectives are being met, e.g., the Business Plan, deployment charts, dashboards, matrices, reports, progress charts, traffic light charts, and management reviews. The objectives must be updated accordingly to demonstrate progress and account for changing circumstances.