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Process Approach

A desired result is achieved more efficiently when activities and related resources are managed as a process.

The term process is defined as a set of interrelated or interacting activities that transforms inputs into outputs.

Wikipedia outlines process management as “the management of the application of knowledge, skills, tools, techniques and systems to define, visualize, measure, control, report and improve processes with the goal to meet customer requirements profitably. ISO 9001 promotes the process approach to managing an organization"

By creating process maps, a company can follow a process approach to managing its business. By identifying a company's processes, its interrelationships and associated risks provide transparency. A process approach can be used not only for a quality management system but also for other systems, such as environment and health and safety. This will help an organization focus its efforts on its processes' effectiveness and efficiency and its management of risks.

Utilizing a process approach can lower costs through focusing on prioritizing performance improvement activities for each process, thereby ensuring effective use of resources tied with risks, and achieving desired outcomes.

The organization will need to identify and determine the sequence and interaction of its processes. This may, depending on the scope, be for the entire organization, a business unit, a department, or an individual area. As part of this identification, it is essential to determine the inputs and outputs for its processes by a team that is familiar with the process. An output from one process can be an input into another. Evaluate possible risks and consequences tied with each process that could impact customers, suppliers, or other stakeholders.

By process mapping, you can review the workflow through a model or pictures of activities that take place in the process and see if there are any omissions, incomplete documented operating procedures, lack of training for a process, or any redundancies or duplication. You can view resource allocations to see if accountability is tied to the process and see the interaction of those involved, as well as the competencies required.

The organization would then determine the criteria and methods needed to ensure operation and control of processes, ensuring availability of resources. Each process needs to be monitored and measured, where applicable, and analyzed so that actions are taken to continually improve.

Process mapping assists in document management, not only procedures developed for operational control but also records maintained.

Typical processes as outlined in an ISO 9001 management system model may include the following; however, every organization has unique processes that would need to be identified, rather than a hierarchy of functions:

1. Management processes

a. Planning (strategic to manage risks, opportunities, continual improvement), leadership, policies, objectives, legality, change management, management review

2. Support processes

a. Quality assurance, environment, health and safety, emergency

b. Resources – human, infrastructure, training

c. Financial

d. Information system support – IT

e. Maintenance and facility management

3. Business realization processes (operational planning and control)

a. Marketing

b. Sales

c. Order processing

d. Design and development

e. Material control (supply chain), purchasing, receiving/ship- ping, inventory, warehousing

f. Production and service

4. Continual improvement processes – performance evaluation

a. Customer satisfaction

b. Management system (MS) processes

i. Audits – internal and registration

ii. Monitoring and measurement

• Analysis – evaluation

• Improvement

iii. Nonconformity and corrective actions

iv. Compliance

c. Product

i. Inspection and test

ii. Verification/validation


Focus: Quality – Customer

1 Have processes been defined? How (matrix, flowchart, mapping)? Have interfaces of key activities between the functions of the organization been identified? What are they?

2 Did you perform process mapping? Did you find duplication or omissions of activities?

3 Have process owners been defined? Does the management team include all the process owners?

4 What are the inputs and outputs for these processes? Has identification of customers', suppliers', and other interested parties' requirements been made for each process? Has the organization outlined activities necessary to obtain a desired output from the process?

5 Have risks been defined for the processes?

6 Has your organization identified the criteria and methods needed to ensure that both the operation and control of these processes are effective?

7 Do you analyze and measure the capability of key activities for the processes?

8 What areas were identified for process improvement?

a. Reducing cost and cycle time

b. Increasing profits

c. Increasing performance

d. Accelerating schedules

e. Providing training

f. Improving customer satisfaction

9 What outcomes would add value to the organization? What strategic plans or performance objectives have been defined to oversee the organization's mission and improve customer satisfaction?

10 What budget allocations are necessary to support process changes?

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