Change Management Procedure: A Comprehensive Guide for Quality Systems

Change Management Procedure

Purpose: To effectively control all types of changes in order to maintain the integrity, adequacy, and effectiveness of the system.

Scope: Applicable to changes in the quality system, products, and processes.

Responsibilities:

• 3.1 Technical and engineering changes are managed by the technical department.* 3.2 System and process changes are managed by the quality department.* 3.3 Other management changes are implemented by the management department. Specific division of responsibilities is outlined in section 4.2.

Work Content and Requirements:

4.1 Factors affecting the quality management system include the six elements of 'people, machines, materials, methods, environment, and measurement'.

• People: All employees involved in the processes, such as new employees, job transfers, new training requirements, changes in job positions (increase or decrease in number), etc. that may affect job skills or requirements.* Machines: Refers to all machinery, equipment, fixtures, etc. used in production, such as additions, repairs, maintenance, etc. that may change the machine's status and require inspection and confirmation.* Materials: Materials used in production (raw materials and auxiliary materials), such as changes in suppliers, supplier engineering changes, storage periods, changes in company materials, etc. that may affect the material's status.* Methods: Production process methods, such as changes in process flow, process requirements, etc. that may cause changes in the production process.* Environment: Changes in environmental conditions such as temperature, cleanliness, static electricity due to climate changes, as well as changes in employee working conditions due to lighting, noise, working hours, etc.* Measurement: Inspection and testing of production processes and quality, such as changes in process inspection, resistance testing, visual inspection, and specialized inspection of crimping depth.

4.2 Change Planning (IATF16949-6.3 Change Planning):

Each department shall plan changes in a systematic manner, taking into account:

• a) The purpose and consequences of the change.* b) The integrity of the quality management system.* c) Acquisition of resources.* d) Allocation and reallocation of responsibilities and authorities.

| Process Classification | Change Review Department | Remarks ||---|---|---|| 4.1 Understanding the organization and its background | Top management - General Manager | || 4.2 Understanding the needs and expectations of relevant parties | Top management - General Manager | || 4.3 Determining the scope of the quality management system | Top management - General Manager | || 4.4 Quality management system and its processes | Top management - General Manager | || 5.1 Leadership and commitment | Top management - General Manager | || 5.2 Quality policy | Top management - General Manager | || 5.3 Organizational roles, responsibilities, and authorities | Top management - General Manager/Administration Department | || 6.1 Actions to address risks and opportunities | General Manager, Department Managers | || 6.2 Quality objectives and plans for achieving them | Quality Department | || 6.3 Change planning | Quality Department | || 7.1 Resources | Administration Department | || 7.2 Competence | Administration Department | || 7.3 Awareness | Administration Department | || 7.4 Communication | Administration Department | || 7.5 Documented information | Quality Department | || 8.1 Operational planning and control | Quality Department | || 8.2 Determination of product and service requirements | Sales Department | || 8.3 Design and development of products and services | Technical Department | || 8.4 Control of externally provided processes, products, and services | Procurement Department | || 8.5 Production and service provision | Production Department | || 8.6 Release of products and services | Quality Department | || 8.7 Control of nonconforming outputs | Quality Department | || 9.1 Monitoring, measurement, analysis, and evaluation | Quality Department, Sales Department | || 9.2 Internal audit | Quality Department | || 9.3 Management review | General Manager, Administration Department | || 10.2 Nonconformity and corrective actions | Quality Department | || 10.3 Continual improvement | Quality Department | |

4.3 Change of Documented Information (IATF16949-7.5.2 Preparation and Updating of Documents):

The responsible department for the documents shall ensure appropriate:

• a) Identification and description (such as title, date, author, document number, etc.).* b) Format (such as language, software version, illustrations) and media (such as hard copy, electronic).* c) Review and approval to ensure suitability and adequacy.

Specifically, the 'Document Preparation/Revision/Disposal Application Notice' shall be completed.

4.4 Changes in Product and Service Requirements (IATF16949-8.2 Changes in Product and Service Requirements):

Whether pre-sale or post-sale, if there are changes in product and service requirements, the organization shall ensure that relevant documents are modified and that personnel are aware of the changes. When there are changes in product and service requirements, ensure that relevant documents (such as contracts, product standards, technical and process specifications, procurement specifications, inspection specifications, etc.) are modified, and that personnel related to the changes are aware of the modified requirements. When dealing with changes in product requirements:

• a) When customers request changes, the organization should request written documentation from the customer and conduct a review.* b) When the organization proposes changes, it should review and notify the customer in a timely manner, and proceed with the changes after obtaining customer confirmation (such as signed confirmation). For partially completed products, consult with the customer and handle appropriately.

All changes shall be processed by the relevant department using the 'Engineering Change Request' and 'Engineering Change Notice'.

4.5 Design and Development Changes (IATF16949-8.3.6 Design and Development Changes):

Necessary controls shall be implemented to identify and review changes during the design and development of products and services, or subsequent processes, to ensure that there are no adverse effects on compliance with requirements. Control shall be carried out in accordance with the 'Engineering Specification and Change Control Specification', and the following documentation information shall be maintained:

• a) Changes in design and development - 'Engineering Change Request' and 'Engineering Change Notice'.* b) Review results - 'Design and Development Review Form'.* c) Authorization for changes - 'Engineering Change Notice'.* d) Measures taken to prevent adverse effects - 'Corrective (Preventive) Action Form'.

When appropriate, design and development changes shall be verified and confirmed, and approval shall be obtained before implementation, following the 'Product Design and Development Specification'. The review of design and development changes shall include evaluating the impact on product components and delivered products. Records of change review results and any necessary actions shall be maintained.

Note: Design and development changes include all technical changes throughout the product life cycle.

4.6 Changes in Product Realization (IATF16949-8.5.6 Change Control):

Controls shall be implemented for changes in the following product realization management processes, in accordance with the 'Product Realization Change Control Specification':

• 8.1 Operational planning and control* 8.2 Determination of product and service requirements* 8.3 Design and development of products and services* 8.4 Control of externally provided processes, products, and services* 8.5 Production and service provision* 8.6 Release of products and services* 8.7 Control of nonconforming output