ISO 9001:2015 Section 8.1 (Operational Planning and Control)

Operational planning and control represents a management area that concerns the design and control of the design and production process of products and the design and provision of services. In operational processes related to the production of products, interaction with the customer usually occurs predominantly at the beginning and end, while in the design and service delivery processes, the customer is involved throughout.

To meet the requirements for the implementation of a Quality Management System, a system of processes is needed that enables the organization to provide products and services that can satisfy customers and other requirements. In many cases, work processes will be designed and will be part of the management system.

However, the nature and complexity of specific projects, contracts, or orders may require that these work processes be adapted or improved to meet particular needs, generating product-specific documents without varying the business process.

These product- or contract-specific documents are addressed in this section of the standard, in its various forms. Operational planning and control represent general planning activities that determine the work and resources needed to undertake a project, honor a contract, or fulfill an order relating to products or services.

The processes necessary to meet the requirements for the provision of products and services are the processes that are necessary to specify, develop, produce, and deliver the required products or services and should be developed in a way that allows planning to meet the requirements without starting from scratch each time.

These processes, therefore, to be useful, should be able to form a framework capable of helping planners decide what targeted actions, what resources, and what specific processes are needed to carry out projects or fulfill the contents of specific contracts and orders.

To serve this purpose, the descriptions of these processes cannot contain details relating to specific products or services, dates, equipment, personnel, or other particular characteristics because each of these pieces of information may need to be determined individually and specifically for each product or service. Hence the need to plan and develop the processes necessary to meet the requirements for the provision of (specific) products and services.

There may be many operational processes required within a given reality. These include, where applicable, the following:

• sales process that determines which of the organization's products and services are required by customers;
• process of planning projects, contracts, or orders that plans the supply of the identified products and services;
• product and service design and development process that designs and validates the entire design process;
• facility development process that designs and builds the infrastructure and environment needed to support the product manufacturing and service delivery processes;
• development process that designs and develops everything needed to produce the product and service characteristics required by customers;
• procurement process that acquires the materials, components, and services needed to realize the design and/or generate or deliver the product or operate the service;
• pre-production process that develops production capacity to full operational status;
• production process capable of producing the product;
• distribution process that delivers products that are in stock;
• service delivery process that provides the service;
• installation process that leads to installing the product at the customer's site;
• maintenance process that maintains over time the equipment that the organization has installed at the organization's site or at the customer's site;
• customer service process that provides post-delivery assistance and warranty service.

Obviously, depending on the areas and applicability, there are many variations in operational processes, and this makes it difficult to provide a broader general overview. For example, where the organization designs products and services in response to customer needs, design would be part of the order fulfillment process; in organizations that install the products they design and manufacture, manufacturing is closely linked to the service delivery process.

Furthermore, orders for existing services and products may not fall within the scope of operational planning and control and go directly to service delivery. Finally, for proprietary products, operational planning and control is guided by the demand creation process that seeks new opportunities that will translate into the development of new products and services.

Various factors are involved in operational planning and control: tasks, timelines, responsibilities, risks, opportunities, resources, constraints, dependencies, and sequences.

The flow charts associated with each process that has been developed within the Quality Management System clearly identify all the tasks. The task of the designer is to determine whether these tasks, their sequence, and the characteristics of the process, in terms of resources and capabilities, require any modification to meet the requirements of a particular project, contract, or order.

The tools most often used in operational planning and control are Gantt charts and PERT charts. The Gantt chart describes tasks and responsibilities on a time scale that shows when tasks need to start and when they need to be completed. PERT charts show the same information but with the visualization of the relationships between one activity and another.

These tools are useful for analyzing a work schedule, determining resources, and establishing whether the work can be completed by the required date using the resources that have been allocated. When planning processes, it is necessary to define several elements. Many of these are reported in section 4.4.1 of ISO 9001, but there are some that are not.

Let's try to give an overview:

• the processes through which the work takes place;
• the interconnections between the processes that form the system;
• the objectives and indicators of the process system;
• the event that triggers each process, the inputs required, and the outputs produced;
• the objectives and indicators for each process within the system;
• the capacity of each process;
• the inputs and outputs of each stage of each process;
• the activities to be carried out in each stage and the criteria required to be certain of having achieved the results;
• the owners and managers of each process;
• the distribution of responsibilities in each process;
• the monitoring of the progress of the various processes, in order to know which stage the work has reached at any time;
• any special tools, equipment, and other physical resources necessary to produce the process output (it is not necessary to specify tools and equipment for general use because personnel should already be trained to select the right tool for each individual activity);
• the methods to be used to produce the output;
• the information required for each activity to be performed as planned, giving the expected result;
• the resources needed to generate the planned results;
• the environment to be maintained during the production of the output;
• the process specifications and processing standards to be achieved; the stages in which verification must be performed and the methods to be used;
• the management, packaging, and marking requirements;
• the monitoring and measurement to be undertaken;
• the methods to ensure the integrity of the measurement performed;
• the methods to be used to operate any equipment that generates the outputs;
• the arrangements necessary to indicate immediately that there are problems and to put in place pre-planned solutions to address them so as to minimize the impact of delays, bottlenecks, etc.;
• the arrangements to indicate that the process outputs are available for use or delivery to the customer;
• the precautions to be observed to protect health, safety, and the environment.

The design requirements of each process should address the risks and opportunities identified in an analysis of the internal and external issues affecting the Quality System. For example:

• verify whether there is an update to the legislation relating to the process, when and if applicable;
• verify whether certain materials may be missing and how this possible lack would place constraints on the proper functioning of the process;
• verify whether there is an opportunity to modernize existing products, services, or processes thanks to new technologies, the launch of an improvement project, or another factor under study. Not all risks derive from the external environment of the process; many derive from internal weaknesses relating to its own design.

In order for a process to provide compliant outputs, it is necessary to create a kind of "protection" that prevents the emergence of any weaknesses that could be preventively estimated thanks to a tool such as the Failure Mode and Effects Analysis (FMEA). The basic approach of FMEA is to answer some questions:

• what could prevent the process from achieving its objectives? This question involves identifying the failure modes within a process, so that they can be remedied;
• what effect would this problem have on the performance of the process? This step serves to clearly identify the effects of the problem on the process, so as to identify which ones to act on preventively;
• what could cause a similar failure? In this way, we identify the causes of a possible problem within the process. The causes could be many and, in this case, it is very useful to arrive at the root cause through the tool of the "five whys";
• how likely is this failure, regardless of any controls put in place? In this way, we set a list of priorities based on the probability of occurrence of a problem. Once all this has been done, it will be necessary to examine the process and establish what provisions are currently in place to prevent, control, or reduce the risk of a failure.

Some error modes could be removed by an intelligent redesign of the process. In other cases, however, review or inspection measures may be necessary or, finally, a strengthening of the instructions linked to process routines, training, or other provisions that can reduce the probability of failure to extremely low levels.

When performing a risk assessment, the failure modes should be realistic and based on the experience of what has happened, perhaps not in our organization but elsewhere. A potential failure is not a failure that might never happen but one that has already happened previously or that the laws of science suggest could happen, should certain conditions be met.

The changes made following the risk assessment should reduce the probability of process failure within manageable limits. It is recommended that the provisions foreseen and the description of the mitigated risks be reported in the description of the process so that, if they prove ineffective, it is possible to identify them correctly and modify them. How do you demonstrate compliance with the requirements of this section of the standard?

Simply by demonstrating that the processes necessary to meet the requirements relating to the provision of products and services have been correctly designed and, therefore, providing:

• evidence that plans exist for the design and production of products and for the design and provision of services that identify the system of processes that will provide the required outputs;
• evidence of the existence of the design requirements of new or modified products, services, and processes and of the path that has led to an assessment of the risks and opportunities identified as a result of a periodic review of the context in which the organization operates.