Conformance1

Tools for conforming to standards, goals and processes

Continual Improvement

  • How is continual improvement defined in ISO 9001:2015?
  • How do companies identify and document continual improvement processes?
  • What are some common auditing questions companies have about continual improvement processes?

What is Continual Improvement?

Continual improvement refers to the ongoing commitment of an organization to improve its services, products and processes. Clause 10.3 of ISO 9001:2015 is devoted to “continual improvement.” Clause 8.5.1 from ISO 9001:2008 required improving the effectiveness of the QMS, but with the release of Clause 10.3 of ISO 9001:2015, organizations are now also expected to improve the “suitability” and “adequacy” of their quality management systems. Organizations must improve the degree their products and services meet customer satisfaction requirements, and they also have to assess the effectiveness of whatever continual improvement processes they employ. It’s impractical to expect organizations to improve all processes in all areas simultaneously, but it’s nevertheless crucial for organizations to adopt a mindset of continual improvement, understanding that it’s always possible to improve, and prioritize the skills and tools necessary to do so.

How Do I Identify Continual Improvement?

Requirements for Continual Improvement

Requirements for continual improvement are tied to specific clauses in ISO 9001, including:

  • Planning;
  • Objectives;
  • Risks and opportunities;
  • Recommendations for improvement;
  • System, process, and product improvements;
  • Data analysis and evaluation;
  • Nonconformity and corrective action.

Lean Assessments

Some direction regarding the requirement for continual improvement is referenced in ISO 9001:2015, stating that the outputs of analysis and evaluation (clause 9.1.3) and the outputs of management review (clause 9.3) should be considered when organizations are identifying any areas needing improvement or opportunities that must be addressed (in order to continually improve).

There are a variety of best practices for identifying and implementing continual improvement processes. One technique is conducting a lean assessment. Lean assessments evaluate the current state of an organization’s processes and identify areas of future improvement and growth. Lean assessments can include evaluations of any area, and often include company culture, market trends, customer satisfaction, necessary employee skills, and the ability to change. Experts recommend including as many people as possible when conducting a lean assessment to learn as much about the company and its stakeholders as possible and gain buy-in from everyone involved before implementing any changes. Ultimately, stakeholders will need to agree upon prioritizing specific areas for improvement before beginning their continual improvement journey to increasing their ROI.

Plan Do Check Act (PDCA) Cycle

Another way to introduce continual improvement into your organization is through the Plan Do Check Act (PDCA) cycle. In this model, each step of the improvement process is identified by the subcategories Plan, Do, Check, and Act.

In the ‘Plan’ Stage, organizations can determine a timeline for internal audits and management reviews. They might also decide on goals and processes required to produce the results that meet customer satisfaction requirements and other organization policies.

In the ‘Do’ Stage, organizations can begin to implement continual improvement strategies. It might be helpful to implement smaller scale changes first to control the process and assess the impact before addressing larger goals. Starting small also minimizes disruption to daily routines while different changes are being tested. 

In the ‘Check’ Stage, organizations will collect data and begin to analyze the results. They will monitor and measure processes and products against company policies, objectives, and requirements, and report the results. There also may be specific activities that have been flagged to ensure quality output remains at the expected standard and is not impacted by any changes that have been implemented. 

In the ‘Act’ Stage, organizations will take decisive actions to continually improve process performance. They will begin implementing the changes on a larger scale, assuming their small-scale tests have been successful. These new changes will become a routine part of the organization’s daily, weekly, or monthly activities, and will continue to be monitored for optimization. Organizations will also need to be cognizant to involve all stakeholders affected by their continual improvements and remain in cooperation with them to continue implementing new processes on a larger scale. 

Not all organizations will have the same areas to assess, but some common improvement opportunity areas are listed below: 

  • Customer satisfaction levels
  • Customer complaints and feedback (surveys, comments, reviews)
  • Market/Industry research and analysis
  • Opinions/Feedback from employees, suppliers, and other stakeholders
  • Internal and external audits 
  • Inspections
  • Product testing
  • Costs
  • Hazards/Risks
  • Nonconformities
  • Storage and handling costs
  • Machinery setup and maintenance
  • Use of building space

Documenting the Continual Improvement Process

Even though it is not a mandatory requirement to document your continual improvement process, it’s nevertheless useful to record all activities that contribute to this process so that an effective system can be maintained. Organizationals will need to implement a continual improvement reporting protocol that defines roles and responsibilities for:

  • Identifying improvement opportunities
  • Assessing and prioritizing continual improvement opportunities
  • Documenting all processes and data collection
  • Reporting results

Some areas where organizations will need to demonstrate their continual improvement plans include:

  • Company policies;
  • Risks and opportunities assessments;
  • Company objectives;
  • Hazards and safety risk assessments;
  • Records analyzing and evaluating data;
  • Audit results and future planning;
  • Management review results;
  • Nonconformity and corrective action records and plans

Common Auditing Questions about Continual Improvement

Auditors will look for evidence that an organization is monitoring processes, analyzing relevant data, and using the results of that analysis to guide change that improves efficiency and output quality. Organizations should also be prepared to illustrate the consistency and cohesiveness of their improvement efforts with each process contributing to achieving overall company objectives such that each process improvement will not be in conflict with the other. 

How Many Processes Need to Have Continual Improvement Plans in Place?

There is currently no requirement that organizations must design improvement plans for all their processes at the same time. Too many variables are difficult to monitor and evaluate, and it would be unrealistic to expect an organization to improve in all process areas simultaneously.

Rather, top management will need to work with the organization to prioritize improvement goals and the allocation of resources necessary to achieve them. These plans should be visible in an audit; auditors shouldn’t have to go looking for improvement efforts. In an audit, organizations should be prepared to identify any improvement initiatives taken since the previous audit, as well as any they are planning for the future.

How Do I Show Improvement If I Am Already Meeting Output Conformance Goals?

No matter how wonderful your processes are working, they can always be made more efficient and effective. The goal of a continual improvement program is to increase stakeholder satisfaction by identifying areas that could be improved. Organizations must consider continual improvement planning in broader terms than mere product or service quality, defining all activities and processes leading up to the creation of the product and service (all departments, suppliers, etc.) and how each plays an integral part in the end result.