ISO9001 System Document Package (32) | Equipment Daily Inspection and Maintenance Work Instruction

Document Description: This work instruction is the implementation document for clause 7.1.3 "Infrastructure" of ISO 9001:2015, classified as a third-level document (work instruction). It is subordinate to the second-level document, "Infrastructure and Equipment Management Procedure" (Article 9 of the package), and connects to record forms such as the "Daily Equipment Inspection Form," "Level Two Maintenance Record," and "Abnormal Handling Form for Equipment Inspection and Maintenance." It details the inspection points, who should inspect when, and the criteria for maintenance to ensure that equipment consistently maintains process capability and prevents batch nonconformities due to equipment failure or precision drift. It is suitable for small and medium-sized manufacturing enterprises using various types of equipment such as stamping, injection molding, machining, packaging, and testing, especially for growing enterprises where equipment inspection and maintenance rely on the intuition of skilled workers, and inspection forms are often just checked off without thorough examination, leading to repairs only when the equipment breaks down—following this document can institutionalize inspection and maintenance from "doing it when remembered" to "doing it according to forms, schedules, and standards."

1. Purpose

To standardize the daily inspection and regular maintenance activities of production equipment, testing equipment, power, and auxiliary equipment, clearly defining the responsibilities, project standards, frequency, abnormal handling, and record requirements. This ensures that equipment remains under control and maintains the specified process capability, meeting the requirements of clause 7.1.3 of ISO 9001:2015 regarding infrastructure, "determining, providing, and maintaining the necessary infrastructure."

2. Scope of Application

This document applies to all equipment within the company that affects product quality and production safety, including:

1. Production Equipment: such as stamping machines, injection molding machines, CNC machining centers, welding equipment, assembly lines, etc.
2. Power and Auxiliary Equipment: air compressors, distribution cabinets, cooling water systems, cranes, etc.
3. Testing and Inspection Equipment (calibration of their metrological characteristics is covered in Article 33 of the package, "Calibration and Periodic Verification Work Instruction for Measuring Instruments")
4. Daily inspection, level one maintenance (operator self-maintenance), level two maintenance (specialist maintenance), and management of inspection and maintenance records.

The full lifecycle management of equipment, including design, procurement, acceptance, major repairs, and scrapping, as well as the equipment inventory, is covered in the "Infrastructure and Equipment Management Procedure."

3. Responsibilities

4. Work Procedures

4.1 Grading of Inspections and Maintenance

The company adopts a "three-level inspection, two-level maintenance" model, with the following levels:

Critical Equipment Identification: Equipment is classified into three categories (A, B, C) based on its impact on product quality, production continuity, and safety. For A-class critical equipment, the inspection frequency and items are more stringent, typically inspected per shift and supplemented with daily patrols.

4.2 Establishment of Inspection Standards

1. The Equipment Management Department compiles the "Equipment Inspection Standard Form" for each (or each type of) equipment, specifying: inspection points, inspection items, judgment criteria (quantitative tolerances, qualitative descriptions), inspection methods (look, listen, touch, smell, measure), inspection frequency, responsible persons, and abnormal handling procedures.
2. Inspection points are marked on the equipment with "inspection labels," such as numbered color dots or arrow stickers, to help operators identify where to inspect.
3. The "Equipment Inspection Standard Form" is used in conjunction with the "Daily Equipment Inspection Form," which is the daily execution form of the former, with items corresponding one-to-one.
4. The standard form is updated promptly when equipment changes (process changes, replacement of worn parts) occur, following the "Document Control Procedure."

Example (Daily inspection standard for an injection molding machine):

4.3 Implementation of Daily Inspections

1. Pre-Startup Inspection. Completed by the operator after taking over the shift and before startup, focusing on: cleanliness and safety protection, normal operation of oil, gas, water, and electricity, any abnormalities left by the previous shift, and whether control switches are in the initial position. The equipment can only be started after confirming it is normal; if any abnormalities affecting safety or quality are found, the equipment must not be started and should be reported immediately.

2. In-Operation Inspection. Conducted according to the specified items and frequency in the inspection form, focusing on noise, odor, temperature, abnormal vibration, leakage, and whether pressure, current, and temperature readings on gauges are within range. If parameters deviate or abnormal signs are detected, the operator should slow down, stop, or report for repair based on the severity.

3. Post-Operation Inspection and Handover. After shutdown, clean the equipment and surrounding area, check for loose parts, and drain condensate water as required. Record the inspection results of the current shift in the "Daily Equipment Inspection Form" and sign it, then hand over the equipment status to the next shift.

4. Inspection Record Method. Operators can initially check off items on the inspection card attached to the equipment, then transcribe and sign the "Daily Equipment Inspection Form" at the end of the shift. Companies with the capability can use QR code inspections or electronic kanban, but records must be traceable and not filled in retrospectively.

4.4 Implementation of Regular Maintenance

1. Level One Maintenance (completed by operators during production breaks or scheduled downtime): Follow the "five tasks" of cleaning, lubrication, tightening, adjustment, and corrosion prevention. Wipe the equipment, add the specified grade of oil, tighten loose bolts, adjust gaps, and handle minor leaks. After maintenance, fill out the "Level One Maintenance Record."

2. Level Two Maintenance (implemented by maintenance personnel according to the plan, requiring shutdown):

1. The Equipment Management Department compiles the "Annual Equipment Maintenance Plan" at the beginning of the year, specifying the maintenance level, frequency, expected downtime, and responsible persons for each piece of equipment.
2. Before maintenance, the production and equipment departments coordinate the downtime, and a "Maintenance in Progress" sign is posted.
3. Level two maintenance includes: partial disassembly and inspection, cleaning and oil change, replacement of expired worn parts, precision testing and adjustment, and safety device calibration.
4. After maintenance, conduct a trial run to confirm that precision and performance meet requirements, fill out the "Level Two Maintenance Record," and update the equipment status sign.
5. Measuring instruments used during maintenance must be within their calibration validity period.

3. Special and Critical Equipment. Boilers, pressure vessels, and lifting machinery must be inspected or regularly tested by qualified institutions according to legal requirements. The precision of critical processing and testing equipment should be tested according to the plan, with results recorded in the equipment file.

Flowchart Text Version:

Compile Inspection Standard Form + Annual Maintenance Plan → Train Operators → Pre-Startup Inspection
   ↓ (Normal)                              ↓ (Abnormal)
In-Operation Inspection → Post-Operation Inspection/Handover        Immediate Shutdown → Hang "Do Not Use" Sign → Report for Repair
   ↓                                     ↓
Fill out the "Daily Equipment Inspection Form"               Maintenance Handling → Inspection/Trial Run Confirmation → Resume Use
   ↓
Implement Level One/Level Two Maintenance as per Plan → Fill out Maintenance Records → Update Equipment Status Sign
   ↓
Monthly/Quarterly Statistical Analysis of Inspection and Maintenance Execution Rates and Fault Data → Analysis → Improvement of Inspection Standards and Maintenance Cycles

4.5 Abnormal Handling and Equipment Status Signs

1. If abnormalities are found during inspection or maintenance, the operator should immediately assess the severity: if it affects safety or product quality, immediately shut down the equipment, cut off the power, hang a "Do Not Use/Out of Service" sign, and report to the team leader and maintenance personnel within 30 minutes.
2. Upon receiving the report, the maintenance personnel should confirm the issue, fill out the "Abnormal Handling Form for Equipment Inspection and Maintenance," and record the phenomenon, initial cause analysis, handling measures, and completion time.
3. After the equipment is repaired, it must be confirmed by the maintenance personnel or equipment supervisor. If necessary, conduct a first article inspection (following the requirements of the "Production Process Control Procedure") to ensure the equipment has restored its process capability before removing the "Out of Service" sign and resuming production.
4. Equipment status signs are recommended to be color-coded: Normal Operation (Green), Standby/Limited Use (Yellow), Maintenance Out of Service (Red), Maintenance in Progress (Blue). Place the signs in a prominent location on the equipment.
5. Nonconforming products caused by equipment abnormalities should be handled according to the "Nonconforming Product Control Procedure." If the cause needs to be identified to prevent recurrence, refer to the "Nonconforming and Corrective Action Procedure."

4.6 Record Management and Statistical Analysis

1. Inspection and maintenance records are collected monthly by the production workshop and archived by the Equipment Management Department, with a retention period of no less than 3 years (long-term retention is recommended for critical and special equipment). Record filling and modification follow the "Record Control Procedure."
2. The Equipment Management Department statistically analyzes the following monthly: inspection execution rate (target ≥98%), maintenance plan completion rate (target ≥95%), equipment downtime due to faults, and fault frequency, as well as the number of repeated faults.
3. For high-frequency and repeated faults, organize an analysis (using "5 Why" or fishbone diagram) to optimize inspection items and maintenance cycles (e.g., shorten the inspection cycle for a specific part, add lubrication points).
4. The statistical analysis results serve as input for management review, evaluating the effectiveness of infrastructure maintenance.

5. Related Records

The record forms involved in this work instruction (fields and filling requirements are as follows):

6. Related Documents

1. "Infrastructure and Equipment Management Procedure" (Article 9 of the ISO9001 System Document Package)
2. "Calibration and Periodic Verification Work Instruction for Measuring Instruments" (Article 33 of the ISO9001 System Document Package)
3. "Record Control Procedure" (Article 4 of the ISO9001 System Document Package)
4. "Document Control Procedure" (Article 3 of the ISO9001 System Document Package)
5. "Nonconforming Product Control Procedure" (Article 22 of the package), "Nonconforming and Corrective Action Procedure" (Article 27 of the package)
6. Clause 7.1.3 of GB/T 19001—2016 / ISO 9001:2015; relevant equipment safety operation procedures.

Usage Instructions

1. Key Points for Customization Based on Actual Enterprise Conditions

1. Equipment Classification Adaptation: For enterprises with a large variety and quantity of equipment, it is recommended to compile general inspection standards by "equipment category" and then detail them for A-class critical equipment. For enterprises with fewer devices, combine the inspection cards for each machine into a single booklet.
2. Inspection Frequency Adaptation: Adjust the frequency based on the criticality of the equipment and its fault history. A-class equipment can be inspected per shift and patrolled daily, while C-class auxiliary equipment can be inspected weekly or monthly, avoiding a one-size-fits-all approach.
3. Organizational Adaptation: For enterprises without an independent equipment department, the responsibilities of the "Equipment Management Department" can be assigned to the production department or a designated equipment manager. For enterprises with outsourced maintenance, clearly specify the maintenance content, acceptance criteria, and record requirements to the contractor.
4. Product/Process Adaptation: In continuous production industries such as chemical and food, the inspection focus should be on safety and hygiene-related parts (pipelines, seals, cleaning). In the machining industry, the focus should be on spindle precision, guide rail lubrication, and tool systems.
5. Information Technology Adaptation: Use QR code inspections or mobile applications to record data, improving execution rates and timeliness. However, ensure that modifications are tracked and data is backed up to meet traceability requirements.

2. Audit Focus Points (Commonly Checked by External Auditors)

1. Randomly check a few in-use devices to verify if the "Daily Equipment Inspection Form" is recorded continuously according to the frequency, without any skipped shifts, and if it is signed by the operator.
2. Check if the items in the inspection form correspond to those in the inspection standard form, and if there is a formalistic issue where the standard form is comprehensive but the inspection form only has check marks.
3. Verify if the "Annual Equipment Maintenance Plan" and maintenance records are consistent, and if level two maintenance is implemented according to the schedule and confirmed upon completion.
4. Check the closure of abnormal handling after inspection: if there is an abnormal handling form, if the equipment is verified as qualified before resuming use, and if nonconforming products are identified and transferred to corrective actions.
5. Ensure that the annual inspection and precision testing reports for critical and special equipment are valid and that the equipment files are complete.
6. Check if the equipment status signs are clear and consistent with the maintenance/out-of-service status.

3. Common Mistakes to Avoid

1. Premature Checkmarks on Inspection Forms: Marking the entire form in advance to pass inspections is a major nonconformity risk—inspections must be conducted and recorded accurately during the current shift.
2. Inspection Without Maintenance: Completing daily inspections without following up on maintenance, failing to replace worn parts on time, and allowing equipment precision to gradually degrade, ultimately leading to batch nonconformities.
3. Vague Standards: Writing judgment criteria as "normal is fine" or "no abnormalities" leaves operators without clear guidance—provide quantifiable or describable standards (e.g., oil temperature ≤55°C, gap ≤0.05mm).
4. Failure to Report Abnormalities and Running Faulty Equipment: Concealing abnormalities to avoid production delays can lead to minor faults becoming major shutdowns or quality incidents.
5. Disconnection Between Records and Maintenance: Issues identified during inspections without corresponding maintenance records, or resuming production without verification, cannot prove that the equipment has restored its process capability.
6. Maintenance Plan on the Wall: A plan that is not aligned with actual execution, with no completion statistics for the annual plan, makes it impossible to evaluate the effectiveness of maintenance.

Inspect according to standards, maintain according to schedules, to prevent equipment from "falling ill"

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.