W hat is QMS? A quality management system (QMS) is a set of policies, processes, and procedures required for planning and execution (prod...
What is QMS?
A quality management system (QMS) is a set of policies, processes, and procedures required for planning and execution (production/development/service) in the core business area of an organization. (i.e. areas that can impact the organization’s ability to meet customer requirements.) ISO 9001 is an example of a Quality Management System.
What is quality assurance?
All those planned or systematic actions necessary to provide adequate confidence that a product or service will satisfy a given requirement for quality (BS 4778: Part 1).
Aim of Quality Assurance
The aim of quality assurance is to improve quality whilst keeping costs to an acceptable level.
The objective of a system used to implement quality assurance, i.e. a quality system, is to determine and rectify the root cause(s) of any problems, thereby reducing faults and wastage. This will, in turn, improve quality and reduce costs. The emphasis is on prevention rather than detection and cure.
Benefits of adopting quality assurance
A properly implemented and the managed quality system should:
- Help to ensure that the company focuses on market needs and requirements.
- Make the company more competitive in the market place due to increased customer confidence in the company output, i.e. a product or service that the customer wants-this include timing.
- Lead to the reduction of cost due to the reduced number of faults and wastage.
- give a measure of performance which will enable any areas for improvements to be identified.
- induce a more organized way of thinking which makes management more organized and effective.
- Provide motivation; motivated employees provide a better working environment in addition to the product or service output benefits.
Scope of quality assurance
Quality assurance should encompass all parts of an organization and all phases of activity i.e. Planning, design, production, maintenance, administration, etc. Collaboration with suppliers and purchasers should also be part of an organization’s quality system.
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Quality Assurance, Quality Control & Inspection
Quality assurance is not an inspection. Inspection is one of the important elements within a system for quality assurance which requires continuing evaluation in the same way as the other elements, e.q. planning,, design/specification, production, etc.
Inspection is activities such as measuring, examining, testing, gauging one or more characteristics of a product or service and comparing these with the specified requirements to determine the conformity (BS 4778: Part 1)
Quality control is the operational techniques and activities that are used to fulfill requirements for quality (BS 4778: Part 1). This definition can be vague, so modifying the term to be more specific is advantageous, e.g. manufacturing quality control is more explanatory.
Quality control is involved with the monitoring of a process and eliminating the cause of any deficient output with any process, or any phase during a contract, which has an effect on quality. The information obtained from inspection, as defined above, is used for quality control.
Quality control deals with the actual measurement of quality performance which is compared against what is required and action are taken on the different. Quality control is asking the question. “is the work/ action being performed correctly??
Quality control does not reach all elements which affect quality, e.g. quality control will rarely do anything to correct a problem relating to management, traceability, training and staff motivation.
Quality assurance applies to all areas which have an effect on quality, and ask the question,; has the work/action been performed correctly”? This question can only be asked after the information has been obtained from quality control and all other departments/areas which affect quality.
Quality Policy
Is the overall quality intentions and direction of an organization as regard quality, as formally expressed by top management.
The company policy on quality within an organization must be decided before a quality system are documented or managed. Quality systems may vary widely between different organizations because of different quality objectives, the different scope of work and different methods of working.
Quality systems
The quality system is the organizational structure, responsibilities, procedures, process, and resources for implementing quality management.
A quality system within an organization is implemented by the use of written procedures that cover all those aspects which govern the final quality of a product or service. The quality manual is a document in which the quality system is referred to as a whole. Reference is made the quality manual to the relevant procedures to be used to implement the system.
Quality systems and associated documentation should ideally be:
- Simple
- Logical
- Clear
- Complete
- Concise
- Correct
- User friendly
A quality system shall produce records reflecting the true situation regarding quality. The record will include audit results, minutes from reviews and any other analysis or feedback with regard to the operation of the system. It is for management to assess these records and act on them accordingly.
Quality system element (ISO 9001):
- Management responsibility
- Quality system principles
- Auditing the quality system – internally
- Economic – Quality – related cost consideration
- Quality is marketing (Contract Review)
- Quality is specification and design (Design control)
- Quality is procurement (Purchasing)
- Quality is production (Process control)
- Control of production
- Material control & traceability (Product identification & traceability)
- Control of verification status (inspection & test status)
- Product verification (Inspection & Testing)
- Control of measuring and test equipment
- Nonconformity
- Corrective action
- Handling & post-production functions
- After-sales servicing
- Quality documentation & record (control of record)
- Personnel (Training)
- Product safety & liability
- Use of statistical methods
- Purchaser supplied product
Quality Plan (BS 4778: Part 1): A document setting out the specific quality practices, resources and sequence of activities relevant to a particular product, services, contract or project.
A quality plan is a supplementary quality system document.
Quality manual and procedure (BS 4778: Part 2): A document setting out the general policies, procedures, and practices of an organization.
The following sequence may be used:
- Document the existing organizational structure and responsibilities of key personnel.
- Document the existing procedure from the receipt of order through to handover to the customer or beyond if necessary
- Analyze the existing system, compare with the requirement and document any proposed amendments.
- Decide on the number of quality document tiers necessary to achieve objectives.
- Propose your structure and any change to existing practices to the organization – management.
- When structure and change are agreed, produce draft quality documents.
- Produce final quality documents when the final drafts are agreed upon.
Quality auditing
A quality audit is a systematic and independent examination to determine whether quality activities and related results comply with the planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.
The audit may be carried out by:
- A company on its own system – known as an internal or first-party audit.
- An organization on a supplier or potential supplier – known as an external or second-party audit.
- Accreditation authorities on an organization who is accredited, or wishes to be accredited, to the authorities quality standard – known as extrinsic or third party audits.
The purpose of an audit on a quality system is to obtain objective evidence of the practices and results of quality-related activities, to then compare these findings against the documented planned arrangements, in order to provide an assurance that those planned arrangements are complied with.
An audit is typically conducted in five phases:
- Opening the meeting
- The audit
- Evaluation of audit findings.
- The closing meeting
- The submission of an audit report including any corrective action request on nonconformity found.
QA Standard:
BS 4778: Quality vocabulary (international terms, quality concepts and related definition)
BS EN ISO 9000-1: Quality management & Quality assurance standard Part 1 for guidelines for selection & use
BS EN ISO 9000-2: Quality management & Quality assurance standard Part 2 for Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003.
BS EN ISO 9001: Quality systems – Model for quality assurance in design, development, production, installation & servicing.
BS EN ISO 9002: Quality system – Model for quality systems in production, installation and servicing.
ISO 9004-1: Quality management and quality standards Part 1 for guidelines
ISO 9004-2: Quality management and quality standards Part 2 for guidelines for services
ISO 10005: Quality management – guidelines for quality plans
BS EN 30011: Guide for auditing quality systems.
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