ISO9001 System Document Package (9) | Infrastructure and Equipment Management Procedure (7.1.3)

Document Description: This procedure corresponds to clause 7.1.3 "Infrastructure" of ISO 9001:2015 and is a core procedure document under the "Resource Management" category of the quality management system (QMS). It is a secondary document. This procedure incorporates the management of facilities such as buildings, equipment, tooling, software, transportation, and information systems into a controlled management system: through the identification and planning of infrastructure, ensuring it meets the needs of the entire product realization process; through a closed-loop management of daily inspections, regular maintenance, preventive maintenance, repairs, and disposal, ensuring that equipment continuously maintains process capability and preventing batch nonconformities due to equipment failure or precision drift. This procedure applies to all types of manufacturing enterprises (mechanical, electronic, chemical, food, etc.) and service enterprises primarily using office facilities and information systems as their main infrastructure. Small and micro enterprises can consolidate the responsibilities into the production department or the comprehensive department and directly apply this procedure. The entire lifecycle management of equipment-type infrastructure, including selection, acceptance, use, maintenance, and disposal, is governed by this procedure.

1. Purpose

To standardize the management of the company's infrastructure and equipment, ensuring:

1. Identification and provision of the infrastructure (buildings, equipment, tooling, software, transportation tools, information systems, etc.) required for product realization, meeting the needs of products and services (7.1.3);
2. Establishment of an infrastructure register, implementing unified numbering and controlled management, ensuring consistency between records, physical items, and cards;
3. Through daily inspections, regular maintenance, preventive maintenance, and timely repairs, maintaining the process capability of equipment and preventing product nonconformities due to facility failure;
4. Standardizing the entire process of equipment procurement, acceptance, renovation, sealing, and disposal, ensuring that resource investment is economically reasonable and disposal is compliant;
5. Retaining documented information on infrastructure configuration, maintenance, repair, and disposal to provide evidence for the effectiveness of the system.

2. Scope of Application

This procedure applies to all infrastructure related to product and service realization within the scope of the company's quality management system, including:

1. Buildings and supporting public facilities: production workshops, warehouses, laboratories, office premises, and their power supply, water supply, gas supply, ventilation, lighting, and fire protection systems;
2. Process equipment: production equipment, machining centers, testing equipment (the metrology management of testing equipment is executed according to the "Control Procedure for Monitoring and Measuring Resources"), tooling, fixtures, molds, and cutting tools;
3. Supportive service facilities: transport vehicles, handling and lifting equipment, storage facilities, information systems (ERP, MES), and communication facilities;
4. Equipment and facilities used by external providers at the company's site that affect product quality.

The following scenarios are not applicable to this procedure and should be executed according to the relevant systems:

1. Calibration and verification of measuring instruments and testing equipment are executed according to the "Control Procedure for Monitoring and Measuring Resources";
2. Facility/admin logistics facilities (such as employee dormitories, canteen equipment) are managed according to the administrative management system;
3. Information security and data backup of computer software systems are managed according to the information management system (the configuration and maintenance of software as a means of product realization still apply to this procedure).

3. Responsibilities

1. General Manager: Approves the annual equipment investment and renovation plan; approves major equipment procurement, disposal, and scrapping matters; provides necessary funds and human resources for infrastructure maintenance; presides over the investigation and handling of major equipment accidents.
2. Management Representative (System Responsible Person): Reviews infrastructure management-related systems and the annual maintenance plan; supervises the execution of infrastructure management by various departments; organizes process performance evaluations related to infrastructure management; reports the status of infrastructure capabilities to the General Manager.
3. Equipment Management Department (Responsible Department, or a designated person by the production department or comprehensive department if no dedicated department exists): Compiles and revises this procedure and accompanying work instructions; establishes and maintains the "Infrastructure Register" and "Equipment Register"; organizes equipment selection, installation, commissioning, and acceptance; compiles and implements the annual equipment maintenance plan; organizes equipment fault repairs and post-repair acceptance; organizes technical appraisals and implementation of equipment renovation, sealing, and scrapping; statistics on equipment performance indicators (such as availability rate, downtime rate); retains records related to equipment management.
4. Using Department: Responsible for the daily use, inspection, and cleaning of equipment in their department; fills out the "Daily Equipment Inspection Form" as required; reports faults immediately and marks the equipment as "under repair" if any abnormalities are found; prohibits operation of faulty equipment; cooperates with the equipment management department in implementing maintenance and repairs; provides training for operators and ensures they are certified (or authorized) to operate the equipment.
5. Quality Department: Participates in the procurement review and capability confirmation of key equipment and special process equipment; supervises the status marking and inspection execution of equipment; participates in the analysis and evaluation of the impact of major equipment failures on product quality; participates in the quality impact assessment before equipment scrapping.
6. Purchasing Department: Implements equipment procurement, supplier evaluation, and contract signing according to the "Control Procedure for Procurement and External Provision"; organizes unpacking and acceptance upon delivery.

4. Work Procedures

(1) Identification and Planning of Infrastructure

1. The equipment management department organizes the identification of the infrastructure required for product realization annually (or during the initial establishment of the system, before the launch of new products) and compiles the "Infrastructure Demand List," which includes: facility name, specifications, model, purpose, process location, quantity, and responsible person.
2. The "Equipment Procurement Application Form" (including purpose, technical requirements, budget, expected commissioning time) is submitted by the using department for new facility needs. The equipment management department organizes a feasibility review involving technical, quality, and using departments, and the application is implemented after approval by the General Manager.
3. Facility configuration should consider: process capability requirements, legal and safety requirements (special equipment must comply with national regulations), production capacity balance, availability of spare parts, energy consumption, and maintenance costs.

(2) Acceptance and Archiving of Equipment

1. Upon delivery of new equipment, the equipment management department organizes the unpacking and acceptance by the using department, quality department, and purchasing department, verifying the accompanying documents (certificate of conformity, manual, drawings, warranty card), and implementing installation and commissioning acceptance, filling out the "Equipment Installation and Commissioning Acceptance Form."
2. After successful acceptance, the equipment management department assigns a unified number, enters it into the "Equipment Register," and establishes an equipment file (one file per machine), which includes: accompanying documents, acceptance records, maintenance records, repair records, renovation records, and scrapping records.
3. Key equipment and special process equipment (equipment whose results cannot be verified through subsequent monitoring and measurement) are confirmed for capability by the quality department. Only after successful confirmation can the equipment be put into production, and the confirmation records are retained.

(3) Daily Use and Inspection of Equipment

1. Equipment operators must be trained and authorized before operating the equipment; operators of special equipment must hold valid special operation certificates.
2. Operators perform pre-shift inspections according to the "Daily Equipment Inspection and Maintenance Work Instruction," confirming the equipment is in good condition before starting it and filling out the "Daily Equipment Inspection Form." If any abnormalities are found, they must immediately stop the machine, hang an "under repair" sign, and report the fault, prohibiting operation of faulty equipment.
3. Equipment status is managed through labeling: Good (green), In Use (normal use), Under Repair (red), Out of Service/Sealed (yellow), to prevent the misuse of nonconforming equipment.
4. Equipment use is managed on a "assigned operator" basis, with the main operator and maintenance responsible person clearly identified in the equipment register.

(4) Maintenance and Regular Maintenance of Equipment

1. The equipment management department compiles the "Annual Equipment Maintenance Plan" by December each year, specifying the maintenance level, cycle, responsible person, and implementation time. The plan is reviewed by the management representative and approved by the General Manager before being issued for execution.
2. Maintenance is implemented in two levels:
   • Level 1 Maintenance (Daily Maintenance): Performed by operators each shift/day, including cleaning, lubrication, tightening, and inspection, and recording in the inspection form.
   • Level 2 Maintenance (Regular Maintenance/Preventive Maintenance): Performed by maintenance personnel according to the planned cycle, including precision checks, replacement of wear-prone parts, electrical inspections, and performance tests, and recording in the "Equipment Maintenance Record."
3. The equipment management department statistically tracks the execution of the maintenance plan monthly, correcting departments that fail to execute on schedule; issues discovered during maintenance are handled according to the repair process.
4. Preventive maintenance items for key equipment (such as periodic oil changes, replacement of wear-prone parts) should be formulated based on the equipment manual and historical fault data, and necessary spare parts should be stocked.

(5) Repair of Equipment

1. When equipment fails, the using department fills out the "Equipment Repair Request Form" (in urgent cases, oral requests can be made followed by a written form), noting the fault symptoms, downtime, and affected product batches.
2. Maintenance personnel perform repairs. If the downtime exceeds a certain limit (e.g., 4 hours) or affects delivery, the responsible person of the equipment management department should be informed for coordination. If key spare parts need to be replaced during the repair, the replacement information should be recorded.
3. After repairs, the using department and maintenance personnel jointly test the equipment to confirm it is running normally, and fill out the "Equipment Repair Record" (including fault symptoms, cause analysis, repair measures, replaced parts, and acceptance conclusion).
4. For repetitive faults (the same fault occurring more than twice within 3 months), the equipment management department should organize a cause analysis and, if necessary, take improvement measures (adjusting maintenance content, renovating equipment, updating equipment) and assess the quality of products produced during the fault period, handling them according to the "Control Procedure for Nonconforming Products."
5. Equipment downtime and repair costs are included in the equipment performance statistics.

(6) Maintenance and Reconfirmation of Equipment Capability

1. Key equipment and special process equipment are reconfirmed for capability by the quality department in the following scenarios: after major repairs, after precision adjustments, after relocation, before reactivation after long-term disuse, and when significant changes occur in product processes.
2. Reconfirmation includes: precision/performance testing, trial production verification (first-piece inspection), and process capability analysis (e.g., calculating Cpk if applicable). The reconfirmation records are stored in the equipment file.
3. For equipment that fails the reconfirmation, repairs, renovations, or downgraded use (with restricted usage and clear labeling) are implemented until it meets the requirements.

(7) Renovation, Sealing, and Scrapping of Equipment

1. Renovation: When equipment needs to be renovated due to process changes, capacity increases, or energy savings, the using department submits an "Equipment Renovation Application Form." The equipment management department organizes a technical review, and the application is implemented after approval by the General Manager. After renovation, the equipment is re-accepted and re-archived.
2. Sealing: For equipment expected to be out of use for more than 3 months, the using department applies for sealing. The equipment management department performs cleaning, rust prevention, power disconnection, and labeling, and registers the equipment. Before reactivation, the "reconfirmation" requirements must be followed.
3. Scrapping: When equipment reaches its service life, has no repair value, or the repair cost is too high, or is obsolete due to technological advancements, the equipment management department organizes a technical appraisal, fills out the "Equipment Scrapping Application Form," and disposes of the equipment after approval by the General Manager. After disposal, the equipment is removed from the register and the "Infrastructure Register" is updated.

(8) Maintenance and Environmental Management of Infrastructure

1. Buildings such as workshops and warehouses are regularly inspected by the responsible department. Any issues such as leaks, damage, or foundation settlement are promptly repaired, and fire escape routes are kept clear and fire protection facilities are maintained.
2. For processes with environmental requirements such as temperature, humidity, cleanliness, and static protection (e.g., precision machining, electronic assembly, laboratories), the using department monitors and records the environment according to the process documents, and the facility management department ensures the normal operation of related environmental protection facilities (air conditioning, dehumidification, purification).
3. Public utility facilities (power supply, water supply, gas supply) are managed uniformly by the equipment management department, and emergency response plans (e.g., power outages, gas stoppages) are formulated to ensure that key processes have emergency support measures.

(9) Performance Monitoring and Continuous Improvement

1. The equipment management department statistically tracks indicators such as equipment availability rate, downtime rate, and maintenance plan completion rate monthly, incorporating them into the department's monthly quality analysis.
2. Abnormal indicators (e.g., availability rate below 95%, repeated faults in the same equipment) are analyzed and improved, and corrective actions are taken according to the "Control Procedure for Nonconforming and Corrective Actions" if necessary.

Flowchart (Text Version)

Using Department proposes demand/procurement application → General Manager approves → Purchasing Department procures → Unpacking and acceptance upon delivery
→ Installation and commissioning acceptance → Numbering and archiving/registering → Operation training and authorization → Daily use and inspection
→ (Abnormal) repair request → Repair → Test and acceptance → Record archiving
→ Regular maintenance (Level 1/Level 2) → Capability confirmation/reconfirmation of key equipment
→ Renovation/sealing/scrapping (approval and disposal, register update)

5. Related Records

The following records are generated by the operation of this procedure and are retained by the equipment management department and relevant departments according to the "Record Control Procedure":

1. "Infrastructure Demand List" (retention period: 3 years after update);
2. "Equipment Procurement Application Form" (retention period: 1 year after scrapping);
3. "Equipment Installation and Commissioning Acceptance Form" (retention period: with the equipment file);
4. "Equipment Register" and "Infrastructure Register" (retention period: long-term);
5. "Daily Equipment Inspection Form" (retention period: 1 year);
6. "Annual Equipment Maintenance Plan" and "Equipment Maintenance Record" (retention period: 3 years);
7. "Equipment Repair Request Form" and "Equipment Repair Record" (retention period: 3 years);
8. "Equipment Capability Confirmation/Reconfirmation Record" (retention period: with the equipment file);
9. "Equipment Renovation Application Form" and "Equipment Scrapping Application Form" (retention period: 3 years after disposal).

6. Related Documents

1. ISO 9001:2015 "Quality Management System Requirements" clause 7.1.3;
2. "Quality Manual" and related procedure document index;
3. "Document Control Procedure" and "Record Control Procedure";
4. "Control Procedure for Procurement and External Provision";
5. "Control Procedure for Monitoring and Measuring Resources";
6. "Human Resource Management Procedure" (operator training and authorization);
7. "Production Process Control Procedure";
8. "Control Procedure for Nonconforming Products" and "Control Procedure for Nonconforming and Corrective Actions";
9. "Daily Equipment Inspection and Maintenance Work Instruction" and "Equipment Safe Operation Procedures."

Usage Instructions

1. How to Adapt to the Actual Situation of the Enterprise

1. Organizational Structure Adaptation: For enterprises with a dedicated equipment department, the responsibilities are assigned to the equipment department. For small and medium-sized enterprises without a dedicated department, the "equipment management department" can be changed to "production department (designated equipment manager)," with major matters directly approved by the General Manager. Micro-enterprises can combine daily inspections, maintenance, and repairs into a single "Equipment Maintenance and Inspection Record Form" to reduce the number of forms.
2. Product Type Adaptation: For process industries (chemical, food), focus on supplementing requirements for pipeline, tank, and clean facility cleaning and cross-contamination prevention. For discrete manufacturing (mechanical, electronic), focus on supplementing precision management and tooling and mold management. For service enterprises, replace "equipment" with "office facilities, information systems," delete clauses related to processing equipment, and add requirements for information system availability and data backup.
3. Special Equipment Legal Requirements: For enterprises involving special equipment (boilers, pressure vessels, lifting machinery, elevators, forklifts, etc.), add clauses for "legal registration, regular inspection, and operator certification" in the procedure, and include inspection reports in the equipment file.
4. Management of Outsourced Equipment: Leased equipment and equipment provided by suppliers on-site should be separately marked in the "Equipment Register" and agreements should be made for maintenance and fault responsibilities to prevent "no one in charge."

2. Audit Focus Points (Internal and External Audits)

1. Consistency between registers and actual conditions: Auditors will randomly select equipment from the register and verify the number, status label, and responsible person on-site. Inconsistencies between records and actual conditions are the most common findings.
2. Authenticity of inspection records: Whether they are filled out on the same day, whether abnormalities are closed-loop (reported, repaired, restored), and prohibit batch filling or proxy signing in advance.
3. Compliance between maintenance plans and execution: Whether the time and content of the plan, records, and actual execution correspond, and whether unexecuted items have explanations and remedial actions.
4. Evaluation of the impact of equipment failures on product quality: Whether products produced during the fault period have been traced and handled, and whether there is evidence.
5. Capability confirmation records for special process equipment: Evidence of capability confirmation and reconfirmation for equipment in special processes such as welding, heat treatment, injection molding, and painting.
6. Acceptance and training authorization for new equipment: Whether acceptance and operator training and authorization have been completed before putting the equipment into use.

3. Common Errors

• Incomplete or lagging registers: New equipment not archived, scrapped equipment not removed from the register, leading to long-term inconsistencies between records and actual conditions;
• Inspection forms are mere formalities: Operators do not inspect, fill out forms at the end of the month, proxy sign, and do not report abnormalities, leading to operation of faulty equipment;
• Maintenance plans and execution are separate: Plans are displayed on the wall, but execution is arbitrary, leading to overuse of wear-prone parts, loss of precision, and batch nonconformities;
• Repairs without records or closed-loop: Faults are considered fixed once repaired, without analyzing the cause or assessing product quality during the fault period, leading to repeated faults;
• Special equipment overdue for inspection: Equipment continues to be used after the inspection validity period has expired, which is both a system nonconformity and a legal risk;
• Arbitrary scrapping: Equipment is scrapped without technical appraisal and approval, or obsolete equipment is used for a long time due to "still usable," leading to long-term operation of faulty equipment;
• Neglect of environmental protection facilities: Faults in clean rooms, constant temperature and humidity facilities are not repaired, leading to process environment loss of control without monitoring data support.

Clear infrastructure registers, frequent inspections and maintenance, strict closed-loop repairs, stable equipment capability.

Knowledge Number: 2.3.1

Knowledge code: 2.3.1

Version: v20260809

Author: QTank QTank is dedicated to providing systematic professional knowledge, methodologies, and practical tools for quality management practitioners, helping enterprises continuously improve their quality capabilities.