ISO 9001 Production Control
As we continue our journey through the ISO 9001 standard and associated requirements, let’s take some time to explore ISO 9001 clause 8.5.1 (Control of Production and Service Provision). We call it ISO 9001 Production Control, but you are welcome to title it however you want. This clause provides higher-level requirements for how to manage and control your production activities along with some specific requirements that don’t fit within any of the other clauses. Remember that production isn’t just traditional manufacturing but also includes the delivery of services. It is really the core function of your organization and the processes and activities required to generate and deliver your “value proposition” to end customers.
In general, ISO requires that you execute and control your production activities including several requirements defining the controls to be established as you create and deliver you products and services. Notice that only those controls that are applicable to your organization, processes, products, services, or customers need to be established. If you exempt yourself from one or more of these requirements, be sure that you can soundly justify the exemption.
Hopefully you start to see how the previous processes, especially the support processes, are now being applied to the core production activities within your organization. As you work through these processes, you may again find the need to iterate and return to and revise some of the previously developed processes to ensure that they properly and correctly apply to your production activities.
ISO 9001 Production Control Requirements
So, let’s take some time to breakdown the ISO 9001 production control requirements within this clause:
Documented Information (a):
ISO requires that you establish documented information that defines the characteristics of the products or services to be delivered. These characteristics are usually provided through drawings, prints, work orders/travelers, job tickets, service orders, contracts/agreements, and other specifications. Documentation should clearly identify the characteristics or attributes deemed critical, key, or necessary to ensure the product or service meets customer and other established requirements.
This requirement also includes “or activities to be performed”. This might include work instructions, checklists, worksheets, flow charts, process maps, procedures, or other similar documentation. In the end, you decide what is needed and best fulfills your requirements.
The second part of this clause requires you to define the expected results of your process. These are the characteristics, measures, observations, performance attributes, etc. of the product or service. They indicate that the product or service meet specifications and conform to requirements.
We discussed product and service requirements in a previous article (ISO 9001 Operational Planning and Control) and now your processes must deliver product or services that meet those requirements. Most of the time these expected results are incorporated into the specifications and other documentation discussed above with actual results recorded in forms, checklists, or work orders indicating that the product or service is compliant. These checks, measures, observations, etc. become part of the in-process and final verification activities which inform the product acceptance and release activities.
Monitoring and Measuring Resources (b):
We covered this topic back in Implementing ISO 9001 Support Processes and this requirement is just saying you need to provide appropriate controlled measuring equipment where needed in your production environment. Make sure the any equipment is appropriate for its use and application and that it is properly controlled per your established monitoring and measurement resource (calibration) processes and procedures.
Verification activities (c):
ISO requires that you periodically check production outputs, results, and activities to ensure that what is being produced conforms to specifications, requirements, and other criteria. This is what is generally referred to as in-process and final verification activities. Review your overall production processes and established key check points to verify that process outputs are compliant and under control. Where, when, and how this is accomplished is really up to you.
Infrastructure and Environment (d):
This one is relatively straight forward. Make sure your production environment is appropriate, and where needed, under control. We also addressed this topic back in Implementing ISO 9001 Support Processes and now you just need to ensure that infrastructure and environment requirements are established and implemented appropriately. Be sure to consider where controls (procedures, work instructions, checklists, etc.) are warranted and what retained documentation (records) is needed.
Implementing ISO 9001 Support Processes covered competency requirements and now you need to ensure that all production personnel are competent for their assigned roles, duties, and responsibilities. If there are competency gaps, be sure to take action to address and close these gaps per your competency processes. In general, this will most likely involve formal process training activities. Are you starting to see the importance of all the “support” processes we previously discussed?
Process Validation (f):
This is a requirement that we have not yet discussed or covered. The general premise is that that processes where outputs cannot be verified against requirements or specifications must be validated. Since most process outputs can be verified to be compliant through test, measurement, observation, etc. this requirement may not apply to your organization. Usually this applies to processes where verification is destructive in nature, cost prohibitive, or defects are only discovered after the product is in service. Consider processes such as painting, coating, plating (anodizing), welding, sterilization, concrete and other similar applications, etc. Also consider the need to validate any software including off-the-self applications that are used within the production environment. If you do have processes that should be validated, and you don’t have the proper internal skill set to complete this task, we recommend that you find the appropriate external resource to help you through the process validation activity.
One activity to consider under process validation that would be applicable and beneficial for all processes regardless of the ability to verify output conformance would be Process FMEA (Failure Modes and Effects Analysis). FMEA is a powerful risk-oriented tool used for process and design analysis which provides a bottom-up assessment of potential failures within a process (or design) along with a method for quantifying the consequences of the failure mode. If you feel that such a tool would be of value, do some research on the subject and if you want to move forward invest in training for an internal resource or there are numerous consultants available to guide you through this activity.
Human Error Prevention (g):
Human error prevention is a new requirement for the 2015 version of the ISO 9001 standard and speaks to “fool proofing” your products, services, and processes or what they call in lean processes as Poka-yoke. Depending on the complexity of your processes, products, or services, this could be a relatively basic exercise or a rather difficult one. If you don’t have any experience with this methodology but feel that it is applicable to your organization, gain some knowledge about the approach and methods and start applying them now with the intention of expanding their application and depth over time throughout the organization. Again, as with the process validation and FMEA methods above, there are many external resources that could help guide and expedite your human error prevention journey. Consider the follow examples of human error mitigation tactics:
- Simplifying processes:Eliminate steps involving human input, effort, documentation, and interaction with the process or product.
- Improved tools:Provide different or improved tools and equipment to production personnel. Consider as an example the use of automatic screwdrivers with preset torque settings rather than manual handheld screwdrivers.
- Improved methods:Consider material and product handling actions to remove unnecessary movement and reduce repetitive actions.
- Automate processes:Invest in technology and other automation to reduce human interaction and involvement. Utilize robotics, cameras and vision systems, and custom material handling equipment where practical.
- Increase competence:Increasing human knowledge, skill, understanding, and overall competence as it relates to processes and products will inherently reduce the potential errors and mistakes.
- Reduce process variation:Reducing variation will directly reduce the potential impact of human interaction with the process and product.
- Fool-Proofing:Removing opportunities for incorrect product assembly, process setup, process control, verification, quality control, etc. will reduce opportunities for mistakes.
- Increased planning effort:Investing more time and effort into the planning stages and activities will provide opportunity to identify issues and design potential mistakes out of the product and process. Utilize tools such as FMEA (Failure Modes & Effects Analysis) and FTA (Fault Tree Analysis) to identify risks and potential process issues before development and implementation.
Consider how human error prevention techniques can be applied and integrated with products, services, and processes during various design and development activities. Also, corrective action activities should address nonconformities associated with human error and apply mistake-proofing solutions when applicable.
Release, Delivery, and Post-Delivery (h):
Once your products have been produced or services readied for delivery, you still need to control and manage their distribution, shipment, installation, and servicing as applicable to your organization. What are the final steps, approvals, etc. to release product for shipment or delivery services to customers? Most organizations will need to ensure that products are packaged, documented, and shipped in a manner that protects the product and provides adequate instruction to the receiver.
If you service products in the form of repair, replacement, refurbishment, etc., establish appropriate processes for completing and documenting these activities. If you are a service organization, make sure appropriate controls are established for delivery of your services to your customers. Again, more on these topics in future articles.
No matter whether you manufacturer widgets or run a cleaning service, ISO 9001 can be applied to your organization and the ISO production control requirements are applicable and value-adding to your business. Consider all the information in this article and adopt the ISO 9001 standard as applicable to your operations. The ISO 9001 eCoach System provides many additional tools and information which can help you make sense of these requirements and apply them to your products and services.