Quality is not an end-state objective, but rather a mature, evolved way of operating a business.
The word “quality” itself is the cause of much confusion. If you ask 50 people to define quality, you will get 50 definitions. But the word has a highly specific meaning as it is used in quality assurance. Under this context, Quality means fitness for purpose – the ability to meet or satisfy a given need and all requirements. Whether the quality of a product or service is appropriate, then, depends on the need it is meant to fulfill. The principles are described by ISO:
- Quality: The degree to which a set of inherent characteristic fulfills requirements
- Quality Control: part of quality management (3.2.8) focused on fulfilling quality requirements (3.1.2)
- Quality Assurance: part of quality management (3.2.8) focused on providing confidence that quality requirements (3.1.2) will be fulfilled
Quality Management Systems (QMS)
Before the level of quality can be determined or judged, it is necessary to understand the customer’s requirements. In any industry there are a number of customers. Critical examples would be the end users of the product, regulatory agencies, such as the Food and Drug Administration (FDA), and industry standards, such as the ISO or CMDR, that are responsible for monitoring the compliance or conformance of the organization. It is critical that regulatory agencies, such as the FDA are seen as valued customers as they represent compelling interests of the general public.
The customer’s requirements are not limited simply to the product or service. Where a product or service is involved, the customer’s requirements encompass all other aspects of the transaction, including price, delivery, timing, after-sale follow-up service and compliance with all applicable regulatory requirements and standards. A clear understanding of all customer’s requirements is essential to the establishment and maintenance of a Quality Management System (QMS).
Quality assurance provides important benefits for customers, but it is even more valuable to the Organization. With quality assurance, companies can improve revenues and cut costs. Obviously, superior quality helps companies compete more successfully for new customers. It is also critical in retaining customers; it is well known that it costs much more to attract a new customer than to retain a present customer. At the same time, internal efficiency improves, providing additional cost savings. Quality assurance prevents inefficiencies and the related labor, material, machine and inventory costs. It also avoids the costs of delayed payments, re-shipment, and repeated service calls.
Remediation Services
Remediation is the process of returning an existing Quality Management System (QMS) to a more effective and efficient state. While often this is a result of an outside party indicating an aspect of Quality is not in alignment with expectations, remediation can also be a proactive result of internal audit assessments.
Fear, confusion, or excessive optimism sometimes is generated by the prospect of a quality assurance system…or an audit. Managers envision loss of decision-making authority, downtime due to excruciatingly thorough inspections, loss of productivity, mountains of paperwork, and added costs. Workers fear punitive actions. Conversely, both managers and workers sometimes expect quality assurance to solve all the company’s problems.
However, these reactions are not the intended purpose, nor the goal of a QMS. Quality auditors must not be responsible for technical and operational decisions…and quality assurance auditing should not be “inspections” in the sense of the FDA or ISO. While reports are generated from quality program audits, paperwork for managers and workers should be moderate to minimal as the QA program should also provide the means for providing responses, corrections, and corrective actions.
Supplier Audits
Poor supplier control has been a focus of many News agencies, regulatory bodies, and consumer advocate groups, as well as customers themselves. The negative press generated from poor supplier control can quickly create business failure.
As a result, supplier audits are a necessity in any organizations success. Every organization needs to have the ability to ensure all purchased, received products, and services conform to specified requirements. It is vital to not only evaluate and select good suppliers but to monitor their performance to expected Quality goals.
An audit can be performed using a range of audit methods on-site or off site. The audit methods chosen will depend on the defined audit objectives, scope and criteria, as well as duration and location. Available auditor competence and any uncertainty arising from the application of audit methods should also be considered. Applying a variety and combination of different audit methods can optimize the efficiency and effectiveness of the audit process and its outcome.
This ensures both the effective means to meet customer requirements but also creates a path of efficient cost control. A lean organization with sufficient supplier control implement proactive cost controls and help eliminate remediation costs of rework, discard, or dreaded recalls.