ISO9001 Certification Audit Frequently Asked Questions

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1. Document control:

A. Approval, distribution and change of internal documents:

1) Engineering drawings have been issued and used without approval;

2) The work instructions were not distributed to specific work positions;

3) The work instructions hanging at the production site were not controlled;

4) There is a phenomenon that the process files are changed directly on the file, and the file change program is not executed.

B. Identification, collection and distribution of external documents:

1) Failure to fully identify and collect national/international and industry standards related to products;

< p>　2) Failure to distribute external documents to relevant departments, such as the quality control department and production department.

2. Filling, management and preservation of quality records:

1) Quality records have been altered;

2) Quality records have no specified retention period;

3) Failure to save according to the storage period, and failure to provide destruction records when expired.

3. Statistics and analysis of quality objectives:

1) The statistics of quality objectives fail to provide original data and cannot grasp the authenticity of the final target statistical values;

< p> 2) The quality objectives have statistics but are not analyzed.

4. Management review:

1) The input information for the management review is incomplete, or the input data cannot be provided;

2) The host of the management review is not the top management

3) There is no relevant evidence of measures taken on the management review resolution matters, such as corrective measures or prevention Measures;

4) There is no record of the tracking results of the last management review resolution.

5. Human resources management:

1) Failure to specify the responsibilities, authority, and ability requirements of each position according to the actual position;

2) Training is planned , has also been implemented as planned, but the implementation effect of the training has not been evaluated;

3) No ability requirements are specified for personnel in special positions, and evidence of training and assessment of these personnel cannot be provided;

4) The requirements for the annual qualification review of special operations personnel (electricians, welders/cutters, crane workers, etc.) are not followed up in a timely manner, and the qualification certificates of individual special operations personnel have not been reviewed annually or have expired.

6. Infrastructure management:

1) New production equipment is put into use without acceptance;

2) No maintenance and upkeep requirements are specified for the equipment ;

3) Special equipment fails to provide evidence of regular verification.

7. Working environment management:

1) Electronics industry: No anti-static treatment is carried out at the production site, such as anti-static paint on the floor or anti-static mats, electrical grounding, personnel Wear an electrostatic bracelet;

2) Food/pharmaceutical industry: The production site fails to provide records of regular disinfection, sterilization, and pest control, and fails to provide records of regular detection of bacterial colonies;

3) General industry:

a) For sites with temperature and humidity requirements, there is no thermometer and humidity, so the temperature and humidity conditions cannot be grasped;

b) The lighting of the color difference inspection post is not inspected Special light source does not meet the requirements;

c) There are dust-proof requirements at the production site and storage site, but dust is found on the products stored on site

8. Product realization planning:

1) Failure to formulate quality goals for product categories or characteristics;

2) Although product realization planning has been carried out, the information is scattered and disorderly, and the relevant responsible persons have no understanding of the product. Not familiar with (or even unclear about) the requirements for implementation planning;

3) Modifications of relevant documents caused by project changes are not carried out in accordance with the requirements of the approval process, and there are private changes; there are some modifications to relevant documents , the phenomenon that some parts have not been modified, and the modification is not complete;

4) The quality control points of the product have not been planned, and it has not been determined when verification, confirmation, monitoring, measurement, inspection and testing need to be carried out.

9. Customer-related processes:

1) The legal and regulatory requirements related to the product (including national/international products, industry standards, specifications, etc.) have not been determined or identified. Adequate;

　2) Post-delivery activities for products (including measures such as those stipulated in warranty terms, contractual obligations [e.g., maintenance services]), and additional requirements that the company deems necessary (e.g., recycling or final disposal) Unclear;

3) When the customer does not provide documented requirements, there is no evidence of confirmation of these customer requirements; the oral contract is not reviewed;

4) The enterprise fails to Planning the operational requirements for contract review based on the characteristics of one's own business process is too formal and has no practical significance;

5) When product requirements change, the relevant personnel are not notified of the changed requirements in a timely manner;

6) Customer feedback (including customer complaints) was handled, but the results were not communicated to customers.

10. Design and development:

1) Common problems in design and development planning:

a) The responsibilities and authorities of the design team members are not clearly defined; < /p>

b) Failure to clarify the requirements for design and development progress, and failure to adjust the design and development plan in a timely manner according to the progress of design and development;

c) Failure to time the review, verification and confirmation activities during planning plan.

2) The design and development input information is insufficient, such as the legal and regulatory requirements applicable to the product are not fully identified;

3) The approval of the design and development output before release is incomplete, such as drawings There are only the names of the compilers, but no signatures of the proofreaders and reviewers;

4) The records of design and development review, verification, and confirmation are incomplete and cannot be carried out according to the planning requirements; the issues raised during these processes are Failure to keep records of improvements;

5) After design and development changes occurred, proper review, verification, and confirmation were not carried out as required;

6) Design and development changes caused changes in relevant documents , failed to revise relevant documents in a timely manner, and failed to notify relevant personnel of the change requirements in a timely manner.

11. Procurement process control:

1) The type and degree of supplier and purchased product control are not determined based on the degree of impact of purchased products on the final product;

2) The evaluation of supplier selection does not cover all material suppliers and outsourcers, especially the evaluation of outsourcers;

3) Relevant supporting documents provided by suppliers (such as quality assurance certificates , material inspection reports, qualification certificates, etc.) are not updated in a timely manner to ensure their effectiveness;

4) The requirements for purchasing products are not notified to the supplier in a timely manner, or the requirements are incomplete, causing the supplier to The supplier failed to supply goods as required;

5) Feedback of quality problems to the supplier was reported, but the effectiveness of the improvement measures taken was not verified in a timely manner;

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6) The verification requirements for purchased products (verification methods and timing) are not clearly defined, and there is a phenomenon of entering the warehouse without verification.

12. Process control of production and service provision

1) The operation instructions required at the production and service sites were not issued/hanged/posted in time. The instruction manual failed to be replaced in time with the corresponding instruction book based on the actual product produced;

2) The faulty equipment did not indicate its status;

3) The inspection instruments and monitoring equipment used on site were not calibrated /Identification of calibration status;

4) Failure to provide evidence of monitoring process parameters of the production process;

5) Failure to hold certificates for special process operators, Or taking up the job without training;

6) The special process is not confirmed, and the special process is not re-confirmed after the production conditions change

7) During the production process The product status (inspection status, processing status) identification is incomplete;

8) The product’s production batch, order number, production date and other information are incomplete;

9) Product protection There are deficiencies, such as stacking products too high, causing damage to underlying products, damaged product packaging, etc.;

10) Customer property is not clearly marked, and abnormalities are not reported to customers in a timely manner.

13. Control of monitoring and measuring equipment:

1) Incomplete identification of equipment corresponding to the control scope of monitoring and measuring equipment, such as pressure gauges/temperature control gauges in injection molding machines Monitoring equipment such as the ammeter/speed control meter of the electric welding machine, the temperature control meter of the oven, and the tachometer of the conveyor belt were not included in the control scope;

2) There was no calibration/verification of the monitoring and measuring equipment. (Verification) formation plan, it is not determined whether it is an internal school or an external school;

3) The internal school has no calibration/verification (verification) specifications, and it cannot be traced back to national standards or international standards;

4) The internal calibration personnel have not received professional training and do not have internal calibration certificates;

5) The monitoring and measuring equipment lacks status identification and it is impossible to determine whether it is within the calibration/verification validity period; < /p>

6) There is insufficient protection for precision instruments, such as anti-vibration, dust-proof and other measures.

14. Customer satisfaction:

1) The monitoring and measurement method of customer satisfaction is too simple, only using the customer satisfaction form survey, and failing to consider customer complaints/ Complaints, returns, customer return visits, customer evaluation reports on suppliers, etc.;

2) The coverage of customer satisfaction surveys is not representative, and only important customers were surveyed;

3) There is a survey on customer satisfaction, but no evidence is provided on how to use this information, for example: how to improve work.

15. Internal audit:

1) The scope of the internal audit is reflected in the plan, but the checklist cannot fully cover it, especially when the plan clearly states that an audit is required. terms, but the checklist and records failed to reflect them;

2) The arrangement of the auditors is unreasonable and the professional abilities of the auditors are not taken into account;

3) The audit schedule The time arrangement is unreasonable, and the time cannot be arranged according to the complexity of the department being audited and the scope of responsibilities;

4) The top manager did not attend the first and last meetings;

< p>　5) The unqualified facts in the unqualified report issued by the internal audit are not clear, are not re-examination, and fail to clearly describe the specific circumstances of the unqualified items;

6) Unqualified items Insufficient rectification: the cause analysis is not in place and the corrective measures are unreasonable;

7) The follow-up verification of unqualified items is not arranged in time, and the verification result report is unclear.

16. Process monitoring and measurement:

1) The production process is monitored, but the analysis of the monitored data is insufficient and the ability to monitor the production process is not available; < /p>

2) There is no planning or monitoring of the system operation process, and only evidence of internal audits can be provided;

3) Insufficient statistics on process performance indicators, and failure to grasp process capabilities .

17. Product monitoring and measurement:

1) The inspection position has not obtained inspection/test operation instructions;

2) The inspection personnel have insufficient capabilities. Insufficient understanding of the use of AQL;

3) The inspection data in the inspection report is insufficient, and the items that should be filled in with specific values ??do not have specific values;

4) Failure to 100% comply with the inspection, The items specified in the test specifications/standards are inspected and tested;

5) In the case of emergency release (or exception release), evidence approved by authorized personnel cannot be provided, and traceability markings are insufficient; < /p>

6) The inspection report lacks the signature of the person authorized to release the goods.

18. Control of non-conforming products:

1) At the production site, the identification of non-conforming products produced during the production process is unclear and not recorded in a timely manner;

2) Incoming unqualified products are dealt with, but suppliers are not required to take improvement measures. Some have passed non-conforming reports to suppliers, but failed to track and verify their effectiveness in a timely manner;

3) Failure to do so during the production process Qualified products were reworked or repaired without re-verification; some were verified, but failed to provide records of re-verification after rework/rework;

4) There was rework and repair in the process, but there was no re-verification. Record the rework and repair process;

5) There are special procurement (concession acceptance) of materials during the production process, but the evidence of approval by authorized personnel cannot be provided;

6) Customers The returned products were returned directly to the warehouse without re-inspection or non-conforming product procedures.

19. Data analysis:

1) Customer satisfaction surveys and statistics have been conducted, but no evidence of analysis has been provided;

2) Quality control department There are statistical qualification rates and non-conformity rates, but no evidence of analysis of non-conformity conditions is provided;

3) There is insufficient understanding of the requirements for data analysis of process performance, and only the performance of the production process is Carry out statistics and analysis, such as rework rate, repair rate, and scrap rate, but there is a lack of evidence of data analysis for the process performance of other departments; (for this, it can be combined with statistical analysis of quality objectives of each functional department and level.)

4) There is a statistical analysis of the purchase qualification rate and purchase timeliness rate of the purchased goods, but it is not possible to analyze the supply capacity of individual suppliers respectively;

5) Regarding the quality objectives Statistical analysis only analyzes projects that have not achieved the target requirements, lacks data analysis for those that have been achieved, and fails to work hard to find opportunities to take preventive measures;

　6) Application of statistical methods and technologies It is narrow, the statistical method is too monotonous and lacks scientificity.

20. Improvements:

1) Most enterprises have basically no record of the implementation of preventive measures; they fail to grasp the timing of the implementation of preventive measures;

2) The regulations on when corrective measures and preventive measures should be taken are unclear and highly arbitrary;

3) The analysis of causes in the improvement report is not in place and remains superficial, lacking comprehensiveness and depth. Analysis; (5M1E human, machine, material, method, measurement, environment > 6 factors should be considered, and the 5 Why? approach should be adopted)

4) Many personnel only Considered emergency measures - correction, but lacked measures to prevent recurrence;

5) Many people are confused about the concepts of correction, corrective measures and preventive measures, and corrective measures and preventive measures coexist in the corrective action report phenomenon;

(Correction: correct the non-conformity, such as redo/rework, repair, replenishment, exchange, etc.; corrective measures: take measures to prevent the recurrence of the non-conformity that has occurred ;Preventive measures: Take measures to prevent potential non-conformities from occurring. When a non-conformity has occurred, the improvement measures taken should be corrective and corrective measures. Preventive measures are only for potential non-conformities that have not yet occurred. Problem. Therefore, there will be no preventive measures in the corrective action report, and there will be no corrective measures in the preventive action report)

　6) Corrective measures/preventive measures are implemented, but not corrected. Record the results of implementation;

7) After the implementation of corrective measures/preventive measures, there is a lack of verification of their implementation effects.

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