ISO 9001 Control Plan Template

Mastering Quality: Your ISO 9001 Control Plan Template Guide

Achieving high quality and consistency in products and services is a critical requirement in any competitive environment. For organizations that are committed to continuous improvement and adherence to globally recognized standards such as ISO 9001, having a well-structured and comprehensive set of control plans is essential. However, ISO 9001 does not specifically require organizations to develop and maintain control plans for their management systems. This article aims to provide an overview of control plans, their importance for ISO 9001, and the key elements that should be included in them.

The ISO 9001’s Control Plan Definition

A control plan is a documented description of the systems and processes used to control product or service manufacture. It was initially designed for the automotive industry (within the framework of the APQP methodology), but the principles that it is based on are applicable to any field of human activity. In general, there is no strict definition of a control plan, since different organizations can apply various approaches and strategies when developing it. However, control plans are usually comprised of three main sections: Process, Characteristics, and Control Method. Additionally, most plans also include such sections as Product/Process Specifications, Measurement System, Sampling Plan, and Responsibility.

Most of the requirements related to control plans can be found in clause 8.5.1 of ISO 9001:2015, which relates to control of production and service provision. More specifically, a control plan provides objective evidence that an organization has established process controls to ensure conformity of products and services, as well as addressed other requirements identified by the organization.

Why ISO 9001 Needs a Control Plan (and Why an Organization Needs It)

A properly developed control plan plays a crucial role in an organization’s ability to achieve high quality and consistency in products or services, as well as meet customer requirements. There are several reasons why an organization should consider developing and maintaining a control plan:

• Ensuring consistency and repeatability: Having a standard way of controlling product or service features helps an organization ensure that products or services are consistent and repeatable, which is of utmost importance in satisfying customer requirements. This aspect is especially relevant to the requirements of ISO 9001.

• Being proactive: Developing a proper control plan requires an organization to answer basic questions related to the identification of critical features, processes, and procedures. The process of developing a control plan is, therefore, inherently linked to an organization’s ability to be proactive in terms of anticipating, recognizing, and addressing quality issues. This requirement is also explicitly mentioned in ISO 9001:2015 (see clause 6.1).

• Facilitating continuous improvement: Control plans are helpful in providing the data needed to support the “Plan-Do-Check-Act” principle used as a framework for implementing the continuous improvement philosophy. Moreover, using control plans can help organizations identify the underlying causes of quality problems and take corrective and preventive measures in order to avoid their recurrence.
  
  

• Being prepared to resolve problems: A control plan can help an organization find an appropriate “reaction plan” that would address a problem and prevent its future occurrences. Therefore, a proper control plan can serve as a critical tool for problem prevention and resolution in accordance with clause 10.2 of ISO 9001:2015.
  
  

• Preparing for and facilitating audits: During an ISO 9001 audit, auditors will look for objective evidence that an organization has established and followed process control procedures in order to make sure that its products and services conform to specified requirements. A control plan, thus, serves as important documentation that can facilitate the audit process and help an organization successfully pass it.
  
  

• Preventing waste and additional costs: Control plans help an organization identify and control critical characteristics in order to prevent defects and the associated costs. Therefore, they serve as an essential tool in an organization’s lean management process.

The ISO 9001 Control Plan Template: The Main Elements

As mentioned above, most control plans can be generally divided into three primary parts: Processes, Characteristics, and Control Method. Most control plans also contain such sections as Specifications, Measurement System, Sampling Plan, Responsibility, and Reaction Plan. Below are the elements that are commonly found in control plans:

1. Basic Information.
   
   

2. Process Information.
   
   

3. Product/Process Characteristics.
   
   

4. Specifications/Tolerance.
   
   

5. Measurement System.
   
   

6. Sampling Plan.
   
   

7. Control Method.
   
   

8. Responsibility.

Basic Information typically includes a control plan’s Part number/name, Process name/number, revision level/date, and preparer/approver. This section allows for easy identification and management of the control plan itself.

Process Information generally describes the process step(operation) and the machine/device/tool used for it. For example, milling, assembly, data entry, and service are a few examples of the types of operations, and a machine, assembly tools, data entry devices, and equipment are examples of the corresponding tools that can be used for them.

A control plan is primarily concerned with product characteristics, which are divided into product and process characteristics. Product characteristics are generally related characteristics of a product or service that should be controlled, such as length, diameter, hardness, color, data content, etc. Process characteristics are related to the features of a process that should be controlled, such as temperature, pressure, speed, torque, time, or specific parameters.

Specifications/Tolerance define the standards/scope that apply to each characteristic, which may include engineering drawings, customer requirements, or other specifications. The measurement system refers to the equipment, tools, or other resources used to measure or verify the characteristic, such as a caliper, a coordinate measuring machine, a visual inspection, or a software audit. The measurement should also have an associated measurement system analysis.

Generally speaking, a sample size refers to the number of data units selected from a population for inspection or verification, while the sampling frequency refers to the frequency with which units are measured or inspected. Together, they comprise the statistical sampling plan, which helps ensure process control with minimal costs and efforts.

A control technique refers to the method used to control a process, such as statistical process control (SPC), Go/No-Go checks, specific process checks, or visual checks. Finally, a reaction plan refers to what actions should be taken if a process goes out of control, such as stopping the line, notifying a supervisor, placing the product on hold, or retraining workers.

The responsibility section indicates who is responsible for taking action in the case of a process being out of control.

How to Implement and Use ISO 9001 Control Plan Template?

An organization must develop and implement an appropriate control plan in a phased manner and at different levels with the participation of many stakeholders in order to fully comply with the requirements of ISO 9001. Below are some key steps that an organization must take when implementing a control plan:

1. Determine processes/products that need to be controlled: An organization must examine its operations in order to determine the processes/products that need to be controlled.
   
   

2. Assemble a team of stakeholders involved: An organization must determine the primary stakeholders who should be involved. These can include engineers, production managers, quality controllers, logistics managers, and others.
   
   

3. Determine product/process characteristics and specifications: This step entails examining each of the selected products and processes to determine all of their characteristics and specifications. In doing so, an organization must take into account the opinions of all stakeholders.
   
   

4. Determine a measurement system and sampling plan: The next step is to determine which measurement system to use and what sampling plan to implement.
   
   

5. Determine control method and reaction plan: An organization must then consider
   and implement various methods that can be used to control each of the selected characteristics. Moreover, an organization must determine what actions to take if a characteristic goes out of control.
   
   

6. Populate the control plan document and get it approved: An organization should then use its selected control plan template to populate it with the information compiled above. The document must then be approved by all stakeholders.
   
   

7. Ensure that all stakeholders are trained: An organization must make sure that all stakeholders understand their roles and responsibilities and know how to use the document and implement the specified actions.
   
   

8. Implement and monitor the control plan: Once the plan is implemented, it must be monitored to make sure that all specified actions are performed.
   
   

9. Review and update the control plan on a regular basis: Finally, an organization must regularly review and update the document in order to make sure that it reflects the current state of affairs.

ISO 9001:2015 Control Plan and Its Elements

Using of a standardized control plan document is beneficial because it ensures uniformity, standardization, and easy access to basic information. A standardized control plan template also ensures that the information required is complete and easy to understand, facilitates training of personnel, and ensures documentation for audits.

Conclusion

The ISO 9001 control plan, which can be seen as an integral part of any quality system, plays a critical role in ensuring the quality of an organization’s products/services. Additionally, it is also essential for meeting the requirements of ISO 9001 and preparing for a quality management system audit. By using a standard control plan template and strictly following the control plan requirements, an organization will be able to maximize the benefit that it gains from the document for its continuous improvement process and achieve the best results in terms of quality control of its products and services.