ISO9001 System Document Package (39) | Work Instruction for Record Filling and Archiving

Document Description: This work instruction is a third-level supporting document for the "Record Control Procedure" (the 4th document in the package). It translates the requirements for "records" in clause 7.5.3 "Control of documented information" of ISO 9001:2015 from "records must be controlled" to "how to write this entry on-site, when to collect this page, where to store these books, and how to appraise and destroy them upon expiration." The second-level procedure document addresses the classification of records, who manages them, how to determine the retention period, and how to manage obsolescence and destruction. This work instruction focuses on the two most error-prone on-site actions in the record lifecycle—filling and archiving: what pens can be used, how to correct errors, how to handle blank spaces, whether to collect daily or at the end of the month, who collects, how to compile a directory, whether to bind into a book or file individually, what environment to store them in, and how to lend them to customers and certification bodies. It is applicable to all manufacturing and service enterprises (mechanical processing, electronic assembly, food and cosmetics, textile and clothing, building materials and hardware, engineering services, third-party testing, etc.) that have established or are establishing a quality management system. For small and medium-sized enterprises without a dedicated records administrator, the responsibilities in Chapter 3 can be combined with the internal staff of the quality department and team leaders, and the archiving process can be changed to "self-check by the team and centralized archiving daily," while the logic and judgment requirements remain unchanged. This document can be directly published and used as a third-level document by the enterprise.

1. Purpose

To standardize the filling requirements, correction methods, collection timing, organization and labeling, archiving methods, storage and protection, borrowing and retrieval, and batch appraisal and destruction upon expiration for all records (including paper and electronic records) in the company's quality management system. This document clarifies the responsibilities and timelines of the record fillers, witnesses, collectors, archivers, and custodians to ensure that records possess authenticity, timeliness, completeness, traceability, and retrievability. It aims to achieve "随时要得到、拿到看得懂、看懂能追责" (随时 available, clear to read, and traceable for accountability) and to avoid typical uncontrolled situations such as post-event supplementation, estimated data entry, isolated pages, archiving without a directory, and unauthorized destruction before the expiration date. This work instruction is specifically formulated for this purpose.

2. Scope of Application

2.1 This work instruction applies to all records formed during the operation of the company's quality management system, including but not limited to: inspection and testing records, equipment and measuring instruments records, production and process records, procurement and supplier records, design and development records, personnel and training records, internal audit and management review records, nonconforming product and corrective action records, customer and complaint records, identification and traceability records, and records related to document and record management itself.

2.2 It covers the following media formats: paper records (forms, ledgers, cards, boards, work tickets), electronic records (ERP/MES/QMS system data, electronic forms, emails, scanned documents, electronic signature records), and hybrid records (paper signed and then scanned for archiving, with the paper copy as the original).

2.3 The following records are not subject to the specific archiving clauses of this work instruction but should still follow the basic requirements of "authentic, timely, and traceable" according to professional management requirements:

• Financial vouchers and accounting ledgers, which should be managed according to national accounting archive regulations;
• Personnel files and employment contracts, which should be managed according to labor and personnel archive regulations;
• Records involving state secrets or customer-specified confidentiality requirements, which should be stored and managed separately according to confidentiality regulations;
• Product nameplates, product history cards, and other records delivered to customers (copies of which should still be archived according to this work instruction).

2.4 This work instruction does not specify the exact retention periods for various records (which are defined in the "Record Retention Period Table" of the "Record Control Procedure"). It only specifies the methods for filling, collecting, archiving, storing, borrowing, and destroying records.

2.5 The company's record management follows five bottom lines: no post-event supplementation, no blacking out or covering, no blank pages, no loose pages without a directory, and no unauthorized destruction before expiration.

3. Responsibilities

3.1 Management Representative (System Responsible Person): Responsible for approving the overall framework of the "Record List" and the "Record Retention Period Table"; responsible for resolving disputes between departments regarding record management, retention periods, and borrowing permissions; responsible for approving record destruction (with the authority to extend retention for records involving product quality traceability and legal responsibilities).

3.2 Quality Department (System Management Department): Responsible for maintaining the company's "Record List" to ensure that each record corresponds to a form number, responsible department, retention period, storage location, and retrieval method; responsible for organizing the promotion and random checks of record filling; responsible for monthly random checks on the quality of record filling and the completeness of archiving, and including these in the management review input; responsible for organizing inspections of the record storage area (fireproof, moisture-proof, pest-proof, and loss-proof).

3.3 Records Administrator (can be concurrently held by the quality department's internal staff): Responsible for collecting records from various departments monthly (or per batch); responsible for organizing, numbering, compiling directories, binding, shelving, and registering the archiving of records; responsible for maintaining the "Record Archiving Registration Form" and the "Record Borrowing Registration Form"; responsible for compiling the "Record Destruction Application (Approval) Form" upon the expiration of the retention period; responsible for daily environmental maintenance and entry/exit registration of the record storage area.

3.4 Department Heads: Responsible for daily supervision of record filling in their departments to ensure that records are completed during the shift, with no blank spaces and no proxy filling; responsible for designating the record collectors and temporary storage points in their departments; responsible for checking the completeness and clarity of records before transfer; responsible for approving record borrowing in their departments.

3.5 Record Fillers (operators, inspectors, team leaders, internal auditors, management): Responsible for filling records truthfully and promptly according to the rules in Section 4.3; responsible for correcting personal errors according to Section 4.4 and signing; responsible for placing records in the designated temporary storage point before the end of the shift; responsible for the authenticity of the content they fill.

3.6 Witnesses/Reviewers: Responsible for witnessing or reviewing and signing records that require dual confirmation (first article inspection, important process parameters, nonconforming product handling, calibration results of measuring instruments, verification of corrective actions). Signatures must not be signed by others or added after the fact.

3.7 Inspection Department and Process Technology Department: Responsible for making uniform regulations on the filling standards, data rounding, and sampling methods in records; responsible for resolving on-site disputes about "how to fill this column" to avoid different filling methods for the same column in different teams.

3.8 Production Department, Procurement Department, Sales Department, Storage Department, and other relevant departments: Responsible for completing, collecting, and transferring records in their departments according to Sections 4.3 to 4.7 of this work instruction; responsible for the completeness and safety of temporarily stored records in their departments.

4. Work Procedures

4.1 Identification of Records and Management of the "Record List"

4.1.1 Each record form must be registered in the "Record List" simultaneously when it is finalized in design. The registration content includes: record name, form number, associated procedure document or work instruction number, filler position, filling frequency, number of copies and their destinations, collector, archiving deadline, storage department, retention period, storage location, and media format (paper, electronic, hybrid). Forms not registered in the "Record List" must not be used on-site to avoid the spontaneous creation of "三无记录" (unnumbered, undated, and unmanaged records).

4.1.2 The "Record List" is maintained by the Quality Department and updated synchronously with system document revisions, new form additions, and form obsolescence. It must not go more than six months without an update. After an update, the relevant departments should be notified, and the on-site versions should be verified to match the list.

4.1.3 The relationship between records and documents must be uniquely identifiable: each form should correspond to a unique form number and version. If a form has multiple uses, it should be handled with sub-columns or sub-pages under the same number, not with a new number, to avoid the same form being managed separately by two departments.

4.1.4 Records are recommended to be categorized as follows for easier collection and retrieval:

4.1.5 Electronic records must also be registered: system name, module or form name, data responsible person, storage location (server/cloud path), backup cycle, and retention period. Simply stating "in the system" is insufficient for future retrieval when personnel changes occur.

4.2 Design Requirements for Record Forms

4.2.1 Form design should ensure "completeness, readability, and consistency." Each form should include at least the following elements: form name and number, version number (linked to the associated document version), page number and total pages, identification column for the filling object (product/batch/equipment/person/date), filling columns, judgment or conclusion column, filler's signature and date column, review or approval column (as needed), and remarks column.

4.2.2 Three requirements for column design:

• Distinguish between mandatory and optional columns: Mandatory columns must not be left blank, and the handling of empty optional columns should be clearly specified in the form instructions or this work instruction.
• Specify units and precision: Columns involving numerical values should indicate units (mm, °C, MPa, kg) and the number of significant digits or decimal places to avoid discrepancies like "12.5" and "12.50" in the same column.
• Include or attach judgment criteria: The judgment column in inspection records should specify the source of the judgment criteria (e.g., "according to drawing dimensions tolerance" or "according to customer specification clause 5.2") to prevent judgments without a basis.

4.2.3 The number of copies and their destinations should be noted in the upper right corner or footer of the form, for example, "三联：第一联质量部、第二联生产部、第三联随产品" (three copies: first copy to the Quality Department, second copy to the Production Department, third copy with the product). Multi-copy forms must be marked with different colors or text to avoid mixing all copies and causing duplicate or missed archiving.

4.2.4 When forms are revised, old versions should be recalled simultaneously (refer to the recall requirements in the "Document Preparation and Approval Work Instruction" in the 38th document of the package). On-site use of forms with the same new number but different printed text is not allowed. Upon the first use of the revised form, the responsible department should demonstrate the filling process on-site to avoid widespread errors due to column adjustments.

4.2.5 Form design should not aim for more columns. Forms that are too complex to fill on-site will inevitably become "supplemental forms," losing their authenticity. During design, automatically collected data (equipment parameters, system time, weight) should be excluded from manual columns, retaining only necessary judgments and signatures.

4.3 General Rules for Record Filling

4.3.1 Timeliness Principle: Records should be completed simultaneously with the action or within the same shift. They must not be supplemented across shifts, concentrated at the end of the week based on memory, or estimated based on production quantities. Records requiring continuous monitoring (temperature, pressure, weighing, environmental conditions) should be recorded on-site at specified intervals, and post-event fabrication based on "average value + reasonable fluctuation" is not allowed.

4.3.2 Pen and Media Standards: Paper records must be filled using blue or black non-fading pens (or ballpoint pens as per company regulations). Pencils, red pens, erasable pens, and highlighters are prohibited for data entry. Record media must be controlled printed versions; using sticky notes, white paper, or the back of scrap paper and pasting them as substitutes is not allowed.

4.3.3 Truthfulness and Clarity: Data must reflect real measurement and observation results and must not be filled "within the qualified range with slight variations." Writing should be neat, and numbers should be clearly written (to avoid confusion between 0 and 6, 1 and 7, 3 and 8). Chinese characters must not be written in cursive. Fillers should write both their handwritten signature and employee number (signing the employee number facilitates traceability). Signatures must not be stamped or signed by others.

4.3.4 Handling of Blank Columns: Columns without content must not be left blank and should be marked with a line: blank spaces within a row should be crossed out with a single horizontal line "——" or a single diagonal line (／) from the lower left to the upper right. Entire columns that are not applicable should be marked "本批无此项" (not applicable for this batch) or "N/A" and signed by the filler. Entire blank pages must not be archived between filled pages.

4.3.5 Four Scenarios Prohibited from Correction: The following scenarios must not be corrected on-site and must be voided and refilled or handled according to Section 4.4 and reported: judgment conclusion columns, signature and date columns, numerical columns requiring dual confirmation, and columns involving product release and nonconforming product handling. Once signed, conclusion records cannot be changed. Any changes to conclusions must be documented in a new "Nonconforming Product Review Record" or "Corrective Action Form."

4.3.6 Data Rounding and Calculation: Measurement data rounding should follow agreed-upon rules (generally according to GB/T 8170 rounding rules), and the rounding precision should match the judgment requirements. Derived values (average, range, pass rate, defect rate) calculated from records should include the calculation formula or indicate the calculation tool, not just the result.

4.3.7 Column Correspondence Must Not Be Misaligned: When multiple operators or equipment are registered on the same form, each must correspond to a specific row. Misaligned or mixed row entries are prohibited. If the form has insufficient rows, a new page should be started and noted in the footer as "续第 X 页" (continuation of page X), and pages should be bound in sequence.

4.4 Standard Procedures for Record Correction

4.4.1 When a pen error occurs, the "strike-through method" should be used for correction, following these steps: strike through the original content with a fine horizontal line (keeping the original content legible) → write the correct content next to it → sign by the corrector → note the correction date. All four steps are mandatory; corrections without a signature or date are considered invalid.

4.4.2 The following practices are strictly prohibited and will be treated as unauthentic records: blacking out, covering with correction fluid, scraping with a blade, covering with tape, tearing and recopying (causing other data on the same page to become unauthentic), replacing the entire page without retaining the original, and having others correct on behalf.

4.4.3 For significant corrections (more than 3 corrections on a page or involving key numerical values), the page should be voided and noted in the remarks column as "此页作废，见重填页" (this page is void, see the refilled page). The refilled page and the original page should be archived together to facilitate tracing the original state; only retaining the refilled page is not allowed.

4.4.4 Electronic record corrections should be made using the system's change tracking function: the system should retain the original and new values, the corrector, the correction time, and the reason for the correction. Electronic forms without a change tracking function must not be used for records requiring traceability; such records should be printed, signed, and archived as paper records.

4.4.5 Any correction must not alter the original conclusion direction: changing "nonconforming" to "conforming" or "out of tolerance" to "within tolerance" is not allowed. Such changes can only be made through the nonconforming product handling process or the corrective action process, generating new records, while the original records remain unchanged and note "已按 XXXX 单处置" (handled according to XXXX form).

4.5 Key Points for Filling Various Records

4.5.1 Each responsible department can develop more detailed "filling examples" based on the above table, using a real (anonymized) filled sample as a reference for new employees. Practice has shown that this is more effective than textual instructions.

4.6 Collection and Organization of Records

4.6.1 Collection Timing: Routine records (inspection, equipment checks, production, storage) should be "completed and placed in the box during the shift." Fillers should place the forms in the designated record temporary storage box or hand them over to the collector before the end of the shift, not leaving them in drawers, toolboxes, or equipment panels overnight. Periodic records (monthly, quarterly) should be transferred within 3 working days after they are formed.

4.6.2 Collection Responsibility: Each department head should designate a collector (usually the team leader or internal staff). The collector should verify at the end of each shift whether the number of records matches the production daily report or work order. Any missing pages should be immediately supplemented. The verification results should be signed on the "Record Transfer Form" to form a closed loop within the department.

4.6.3 Transfer Verification: When transferring records to the records administrator, both parties should jointly verify three items: the number of records matches the "Record Transfer Form," each record has a signature and date, and the form number is the current version. After verification, both parties should sign the "Record Transfer Form," each keeping a copy. Missing or blank records discovered during transfer should not be "collected first and dealt with later" but should be noted on-site and supplemented within 1 working day.

4.6.4 Sorting and Numbering: The records administrator should sort received records by "category—month/batch—form number" and number each page continuously (e.g., handwrite "第 X 页／共 Y 页" or stamp the page number). The sorting principle should maintain the sequence of original records for the same batch and process; sorting by page size or handwriting quality is not allowed.

4.6.5 Temporary Storage Protection: Records in departmental temporary storage points should be stored in locked file cabinets or designated shelves, protected from moisture, oil stains, and loss. Production site records must not be mixed with chemicals, oils, or cups to avoid fading or blurring of the writing.

4.7 Archiving of Records

4.7.1 Archiving Method: In principle, records should be archived monthly (weekly for companies with fast production rhythms, and by batch for one-time projects): the records administrator should complete the archiving of the previous month's records within 5 working days of the following month. Records with legal or customer traceability requirements (inspection, testing, measurement, release) must not be archived across quarters.

4.7.2 Binding into Books: Records of the same category and month (or batch) should be bound in sequence. Binding requirements include: adding a cover (indicating the record name, month or batch, book number, number of copies and pages, archiving date, records administrator), adding a directory page (listing the form number and page number of each record in the book), and binding securely (three-hole binding or glue binding, not using metal pins or paper clips to avoid rust and falling off). The spine or cover should indicate the book number for easy shelving and retrieval.

4.7.3 Separate Archiving Scenarios: The following records should be bound separately or filed individually, not mixed with ordinary records: nonconforming product handling and acceptance with concession records, customer complaint and major quality issue records, internal audit and management review records, original calibration certificates of measuring instruments, copies of technical requirements and acceptance documents provided by customers, and tracking records for corrective and preventive actions.

4.7.4 Archiving Registration: Immediately register each book in the "Record Archiving Registration Form" after archiving. The registration content includes: book number, record name and category, period or batch, number of copies and pages, form number, source department, archiving date, storage department, storage location (shelf number/cabinet number/layer number), retention period (year/month), and records administrator's signature. The registration form should be bound annually and serve as the main index for the record storage.

4.7.5 Storage and Retrieval: The record storage area should be divided by category, sorted by year, and located by book number to ensure "说明位置即可取出" (specifying the location allows retrieval). Any category of records should be retrievable within 10 minutes through the three-level index of "Record List" → "Record Archiving Registration Form" → shelf number. The situation "知道有这份记录但找不到" (knowing the record exists but unable to find it) must not occur.

4.7.6 Archiving of Electronic Records: System-based electronic records should be retained in the system for the specified period and backed up completely every quarter (the backup medium or cloud path should be registered in the "Record List"). Scanned PDF files should be organized into folders by "year/category/month," with file names uniformly formatted as "form number_period_batch or sequence.pdf." Using names like "新建文件夹" (new folder) or "扫描件1" (scan 1) that are not searchable is prohibited.

4.8 Storage, Protection, and Borrowing of Records

4.8.1 Storage Environment: The record storage area or file cabinets should meet the following conditions: dry and well-ventilated, avoiding direct sunlight, away from water sources and heat sources, with pest control measures, and equipped with fire extinguishers. Paper records must not be stored in areas with standing water or roof leaks. The temperature and humidity of the storage area should be maintained within the range of a conventional office environment, and desiccants should be placed and replaced quarterly in areas with high humidity.

4.8.2 Security and Permissions: The keys to the record storage area and file cabinets should be kept by the records administrator and the quality department head. Records containing customer technical information, formulas, and process parameters should be stored separately according to confidentiality requirements, with limited access. When personnel change, the keys and list should be handed over, and the handover records should be archived.

4.8.3 Borrowing Rules: Internal borrowing requires the approval of the borrowing department head and registration in the "Record Borrowing Registration Form" (borrower, department, book number and name, reason for borrowing, borrowing date, return date, records administrator's signature). Originals should not be lent out in principle; if they must be taken off-site, they should be treated as photocopies, which must be approved by the quality department head and registered with the number of copies and their destinations. Originals borrowed should be returned within the agreed 3 working days, and overdue returns should be followed up and recorded by the records administrator.

4.8.4 Customer and Certification Body Review: When customers, third-party auditors, or certification bodies need to review records, the quality department should receive them and accompany them throughout the process. Originals should be retrieved according to the auditor's checklist, and both retrieval and return should be registered. If photocopies are needed for evidence, they should be processed according to Section 4.8.3 and accompanied by a confidentiality statement. Temporary compilation of records from the site to meet audit requirements or providing records that are clearly obsolete or not from the company is not allowed.

4.8.5 Use of Record Copies: On-site used record copies (such as the second copy of inspection records) have the same effect as the original, but upon archiving, each record should have a unique original archiving destination to avoid disputes over "which copy is the official one" due to multiple departments archiving the same record. If both copies are originals, the archiving destinations for each should be specified in the form instructions.

4.9 Appraisal and Destruction of Records Upon Expiration

4.9.1 The records administrator should conduct an expiration count of in-storage records every six months (recommended in January and July). Records that have reached their retention period should be screened according to the "Record List," and an "Expired Record Counting Form" should be compiled, listing the book number, record name, period, retention period, and actual in-storage status.

4.9.2 Expired records should be appraised before destruction. The appraisal focuses on four points: whether they involve traceability requirements for product safety and personal safety; whether there are unresolved customer complaints, quality disputes, or lawsuits; whether they involve legally mandated retention periods (such as product liability, measurement, and special equipment requirements); and whether they are still needed for traceability of in-process products. If any of these points apply, the retention period should be extended, and the new retention period should be updated in the "Record List."

4.9.3 The appraisal should be organized by the quality department, involving relevant departments (production, technology, sales, legal, or external consultants) to confirm the conclusions. The appraisal conclusions and reasons must be clearly stated in the "Record Destruction Application (Approval) Form," not just "已到期" (expired).

4.9.4 Destruction Implementation: After approval, the records administrator should destroy the records with at least one other person from the quality department. The destruction method should be chosen according to confidentiality requirements, such as shredding, recycling by a paper mill, or incineration as per regulations. The destruction process should be recorded (book number, record name, number of copies and pages, destruction method, destruction date, and signatures of two supervisors), and the destruction record itself should be archived for long-term retention.

4.9.5 Prohibited Actions: Personal unauthorized handling of expired records; selling records containing customer information or process parameters as waste paper; prematurely destroying records without appraisal due to storage space constraints; and not archiving destruction records. Any of these actions, if discovered, will be subject to company regulations and treated as nonconformities in internal audits.

4.10 Record Filling and Archiving Process (Textual Flowchart)

Form Design and Registration in the "Record List" (Quality Department, synchronized with documents)
 → Controlled Printing and Distribution (Document Controller, indicating the number of copies and their destinations)
 → On-site Filling According to Rules (Fillers complete during the shift, correct according to standards)
 → Witness/Review Signature (Dual-signed records completed on-site)
 → Place in Departmental Temporary Storage at the End of the Shift (Fillers)
 → Department Collector Verifies the Number of Copies (compared with production daily report/work order)
 → Transfer and Verify with the Records Administrator and Sign the "Record Transfer Form" (both parties sign, each shift or each week)
 → Categorize, Sort, Number, and Bind into Books (Records Administrator, within 5 working days of the following month)
 → Add Cover and Directory, Register in the "Record Archiving Registration Form"
 → Shelve and Store (categorized by year and book number, searchable through three-level index)
 → Daily Storage and Environmental Protection (monthly checks by the records administrator, semi-annual expiration counts)
 → Borrowing and Review Registration (in the "Record Borrowing Registration Form," originals not lent out)
 → Expiration Appraisal (organized by the quality department with relevant departments, verifying four key points)
 → Approval for Destruction or Extended Retention (Management Representative)
 → Supervised Destruction by Two or More People and Archiving of Destruction Records (long-term retention)

5. Related Records

Filling Instructions: The "Record Transfer Form" should be in duplicate, with each department keeping a copy. It must not be signed and kept by only one party. The "Record Archiving Registration Form" should be bound annually, and the registered content must match the actual storage location. If the storage location changes, it should be updated and noted in the remarks column with the adjustment date. The "Record Borrowing Registration Form" should be used to verify the completeness of the original upon return, and any missing or damaged pages should be noted and reported to the quality department. The "Record Destruction Application (Approval) Form" must correspond one-to-one with the "Record Destruction Record," and destruction must not be implemented for unapproved applications. The "Record Storage Environment Inspection Form" should be filled monthly and must not be supplemented in a concentrated manner every six months.

Example Row (for "Record Archiving Registration Form"):

Example Row (for "Record Borrowing Registration Form"):

6. Related Documents

• "Record Control Procedure" (QMS-PD-QM-02)
• "Document Control Procedure" (QMS-PD-QM-01)
• "Document Preparation and Approval Work Instruction" (QMS-WI-QM-09)
• "Nonconforming Product Review and Handling Work Instruction" (QMS-WI-QM-08)
• "Corrective Action Implementation and Verification Work Instruction" (Document 45 in the package)
• "Internal Audit Implementation Work Instruction (Internal Auditor Manual)" (Document 42 in the package)
• "Knowledge Management Procedure" (QMS-PD-QM-06)
• GB/T 19001-2016 "Quality Management System Requirements" Clause 7.5

Usage Instructions

Three Adaptations for Actual Enterprise Conditions

1. Adaptation to Organizational Structure: Replace "Quality Department" and "Records Administrator" in Chapter 3 with the actual departments and positions of the company (use "Quality Department Internal Staff and Records Administrator" if there is no dedicated records administrator). In companies where one person holds multiple positions, the filler and collector roles can be combined, but the responsibility for record authenticity and the responsibility for archiving verification should not be solely borne by one person. It is advisable to retain a two-level system of "department self-check + quality department random check," which is the most commonly verified independent design in audits.
2. Adaptation to Product Type: For flow-type and large-batch continuous production companies (food, chemicals, building materials), change "monthly archiving" to "archiving by production batch" and strengthen the interval requirements for process parameter records. For single-piece small-batch and project-based companies (engineering services, testing institutions), change "by batch" to "archiving by project number," with one book corresponding to one project and the project number and customer code noted on the cover. Pure service companies can replace "inspection records" with "service provision process records, service delivery confirmation forms" and "equipment checks" with "service facility and tool inspection records." The correction rules in Section 4.4 and the destruction rules in Section 4.9 remain unchanged.
3. Adaptation to Scale: Companies with fewer than 50 employees can simplify binding to "one binder per month, categorized in bags," but the "Record List," "Record Archiving Registration Form," and "Borrowing Registration Form" must not be omitted. Highly informatized companies can create electronic ledgers for archiving and borrowing registration, but they must retain change tracking and export backups and must not cancel the expiration appraisal and destruction approval due to "being in the system."

Audit Focus Points

• Authenticity Under Scrutiny: Auditors often randomly select an on-site record and ask the filler, "When was this entry made?" "Where did this data come from?" "What was the status of the equipment at the time?" If the filler cannot answer or the answer does not match the actual situation, the record will be deemed unauthentic and a nonconformity will be issued. Record authenticity is one of the most serious judgment items in ISO 9001 audits.
• Traceability of Corrections: Check if there are any blacked-out, covered, pasted, or torn pages in the records. Standard strike-through corrections should have the original content legible, the correct content, the corrector's signature, and the correction date. Missing any of these will result in a nonconformity under clause 7.5.3.
• Timeliness Evidence Chain: Cross-check the dates and times in inspection records with production daily reports, warehouse entry forms, and equipment checklists to identify any characteristics of concentrated supplementation, such as "production date before inspection date concentrated at the end of the month."
• Completeness and Retrievability: Auditors often request to see "the finished product inspection record for product A in March 2026" to test whether the company can retrieve it within a reasonable time. If the auditor has to search through boxes and only finds a few scattered pages, the record control will be deemed ineffective.
• Basis for Retention Periods: Check if the retention periods in the "Record List" have a basis (laws, customer requirements, or company-defined). Avoid the situation where all periods are vaguely written as "1 year." Industries such as automotive, medical devices, and special equipment should pay attention to industry-mandated retention periods.
• Compliance of Destruction: Check if there are any expired records that have disappeared without appraisal and verify the correspondence and supervisor signatures in the "Record Destruction Application (Approval) Form" and the "Record Destruction Record."
• Traceability of Electronic Records: Check if system data modifications retain the modifier, time, and before/after values. For electronic forms without traceability, confirm that they have been signed and archived according to the paper process.

Common Errors

1. Supplementing at the End of the Month: Inspection records and checklists are concentrated and filled based on memory at the end of the month, with continuous dates but consistent handwriting and pen color, easily identifiable. Once recognized, the credibility of the entire batch of records is compromised, making it a common and serious nonconformity in audits.
2. Writing Only Conclusions, Not Data: Inspection records are filled with "合格" (conforming) or "OK" throughout, without actual measurement values, sample numbers, or judgment criteria. This makes it impossible to trace or analyze process capability, reducing the record to a mere notification.
3. Blacking Out and Covering Corrections: To save effort, black pens are used to cover incorrect data, or paper is pasted over or torn and recopied. This may make the on-site records look neat but leaves the most direct evidence of tampering.
4. Leaving Blank Columns Unhandled: Entire columns are left blank, making it impossible to determine if they are "未发生" (not occurred) or "漏填" (missed). Both explanations are disadvantageous during audits.
5. Proxy and Post-Facto Signatures: One person signs for the entire team's inspection, or signs on behalf of a leader after the fact. Signature comparison will expose the discrepancy and constitute an unauthentic record.
6. Loose Pages Without a Directory: Records are stored in piles or clipped together, with no page numbers, directory, or book numbers, making retrieval time-consuming and prone to page loss.
7. Delayed Archiving: Records from the second quarter are still in departmental drawers at the end of the year, with no transfer documentation. In the event of customer complaints or recalls, it is impossible to provide a complete traceability chain in a timely manner.
8. Duplicate Archiving or No Archiving: The same inspection record is stored in two or three departments, leading to inconsistent content and no way to determine which is the official one. Alternatively, the assumption that "the electronic system has it" leads to no one managing the paper original.
9. No Traceability for Borrowing: Original records are borrowed without registration or return deadlines, leading to long-term retention by individuals and inability to present them during audits.
10. Arbitrary Destruction Upon Expiration: Expired records are sold as waste paper, prematurely cleared due to storage space constraints, or destruction records are not archived. For records involving product safety and customer information, this is not only a nonconformity but may also lead to legal liabilities.
11. No Backup for Electronic Records: All quality data is stored in a single system without backups or recovery tests, leading to large-scale loss of records in the event of system failure or accidental deletion, with no paper backup.
12. Version Mismatch Between Records and Documents: The on-site form is the new version, but the "Record List" still shows the old version number. Alternatively, the old version is not recalled after form revision, leading to two different filling methods for the same column and inability to make a uniform judgment upon archiving.

Complete during the shift, bind monthly, appraise and destroy upon expiration

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 to continuously enhance the quality capabilities of enterprises.