The importance of quality systems & standard operating procedures.

High levels of quality are essential to achieve Company business objectives. Quality, a source of competitive advantage, should remain as the DNA of the Company and its products and services. High quality is not an added value; it is an essential basic requirement.

Quality does not only relate solely to your end products and services the Company provides but also relates to the way the Company employees do their job and the work processes they follow to produce its products or services.

The work processes should be as efficient as possible and continually improving. Company employees constitute the most important resource for improving quality. Every employee in an organisation is responsible for ensuring that their work processes are efficient and continually improving, is yours?

Are you managing your Quality System from the top?

Top management are required to provide the training and an appropriate environment to motivate and promote teamwork both within and across the organisation for employees and teams to improve processes.

Ultimately, everyone in a Company is responsible for the quality of its products and services.

A company can best achieve its business objectives by establishing and managing robust quality systems with their integral quality documents including standard operating procedures (SOPs).

How do you define a quality system?

A quality system is defined as the organisational structure, responsibilities, processes, procedures, and resources for implementing quality management.

Quality management includes those aspects of the overall management function that determine and implement the Company quality policy and quality objectives. Both quality control and quality assurance are parts of quality management. Both quality control and quality assurance systems must be commensurate with the Company business objectives and business model. The two together constitute the key quality systems.

Top management commitment and active involvement in the establishment, management, monitoring and improvement of quality systems is critical and is achieved by:

• Defining and documenting a quality policy and quality objectives and ensuring that both the policy and objectives are understood and implemented by all employees at all levels.
• Ensuring that appropriate processes are implemented to fully satisfy customer needs and expectations and Company objectives.
• Defining and documenting the responsibility, authority and interrelation of key personnel managing the quality systems.
• Providing adequate resources for implementing and maintaining the quality systems.
• Conducting scheduled management reviews of the quality systems to assess their continued suitability, adequacy, effectiveness, and efficiency; and
• Deciding on actions for continual quality improvement.

Breaking down the differences between Quality Assurance and Quality Control.

Quality control is focused on fulfilling quality requirements, and it encompasses the operational techniques and activities undertaken within the quality assurance system to verify that the customer requirements for quality have been fulfilled.

Quality control is generally the responsibility of the operational unit and quality is infused into the outputs and verified as they are being generated. Therefore, quality control is an integral part of the daily activities occurring within its operation.

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Quality assurance, on the other hand, is focused on providing confidence that quality requirements are fulfilled. As it includes all those planned and systemic actions that are established to ensure that the processes are performed to meet the requirements and the data are generated, documented (recorded), and reported in compliance with specifications and applicable regulatory requirements.

Quality assurance is the responsibility of the quality assurance department (or top management). The mission of a quality assurance department is to provide an effective and efficient quality assurance system and counsel for the operational unit. The quality assurance department must be manned by an adequate number of dedicated and adequately qualified, trained, and experienced personnel with well-developed interpersonal skills.

These well-developed interpersonal skills will provide the quality assurance personnel with persuasive, diplomatic, tactful and resilient qualities generally required of them. The quality assurance department must operate independently from the operation team and it must regularly perform quality review activities (self-inspection audits/internal audits) to ensure compliance within its operational unit with its Company quality standards.

Why do manufacturers need SOPs today?

Standardisation is defined as an activity that gives rise to solutions for repetitive application to problems in various disciplines i.e., manufacturing and it is aimed at achieving the optimum degree of order in a given context.

Generally, the activity consists of the process of establishing (determining, formulating, and issuing) and implementing standards. Therefore, standards are the ultimate result of a standardisation activity of procedures within the quality system that consist of quality documents or documents related to the quality systems.

The quality documents consist of Company policies, quality management plan, SOPs, working instructions, guidelines, forms, templates, logs etc. They are established by consensus and approved by nominated personnel and they provide for common and repeated use, rules, guidelines or characteristics for activities or their results with a view to promote transparency, consistency, reproducibility, interchangeability and to facilitate communication.

The hierarchy and types of quality documents relevant to quality systems will depend upon Company business objectives and business model. SOPs are Level 2 quality documents and, along with other relevant quality documents, ensure the effectiveness and efficiency of your quality systems.

Simply put, SOPs specify in writing, who does what and when, or the way to conduct an activity or a process. SOPs establish a systematic way of doing work and ensure that work is done consistently by all persons who are required to do the same task. SOPs must be well written in order to provide an effective control and prevent errors from occurring, thereby minimizing waste and rework.

However, poorly written SOPs are a source of misinformation. To be user friendly, they should be clear, unambiguous and must be written in plain language. What is key is that they need to be understood by their users. SOPs are controlled documents and are best written by persons involved in the activity, process or function that is required to be specified or covered in the SOP.

SOPs must be reviewed prior to their approval for release, for adequacy, completeness and compliance with Company standards and all applicable legal, ethical, and regulatory requirements. They must be reviewed and updated as required over their life cycle and any changes made to the SOPs must be re-approved. They must bear a revision status on them and their distribution must always be documented and controlled.

When obsolete SOPs are required to be retained for any purpose, they should be suitably identified to prevent unintended use. Only relevant SOPs in their current version must be available at points-of-use and must remain legible. SOPs are not mandatory within ISO 9001 but are a must for the implementation of your procedures to meet your customer requirements, within the scope of your quality system.

For an activity to become the topic of an SOP, it must be either subject to regulations or it must address a task important within quality systems or between quality systems and other functional requirements. Quality systems related SOPs should generally cover the business and operational critical control requirements in order to capture the core quality control and quality assurance activities and processes to assure delivering its intended quality standards.

What are the benefits of a quality management system?

The importance of properly established and managed quality control and quality assurance systems with their integral well-written SOPs and other quality documents for the achievement of Company business objectives cannot be ignored. They serve as a passport to success by assisting the Company to achieve high-quality processes, procedures, systems, and people, with eventual high-quality products and services and enhancement of the following:

• Customer satisfaction, and therefore, customer loyalty and repeat business and referral.
• Embedded quality processes under the scrutiny of plan-do-check-act to eliminate waste and the need for rework;
• Operational results such as revenue, profitability, market share and export opportunities;
• Alignment of processes with achievement of better results.
• Understanding and motivation of employees toward the Company quality policy and business objectives, as well as participation in continual quality improvement initiatives; and
• Confidence of interested parties in the effectiveness and efficiency of the Company as demonstrated by the financial and social gains from Company performance and reputation.

Remember, the reasons why you have invested and implemented a quality system !

A quality management system provides formal answers to the questions of who is responsible for what within your organisation, what goals they should be working towards, and what processes they should be following to get there. What better way than to implement systems at every level, with accountabilities in all areas through proper ownership of processes and a proper view above compliance that “almost” is never good enough!

In summary 

When quality is truly embraced in all facets of a company, and quality operates as the DNA of the organisation, you will consistently achieve a better product, service and face fewer head winds in times like we are currently facing. In turn, the importance of your quality system will be capitalised by enhancing your company reputation and customer satisfaction, finding your niche and achieving your business goals.