What qualifications are required for internal auditors and quality supervisors?

Internal auditors and supervisors are indispensable key personnel in laboratories. They differ in many aspects, and their normal and effective work can promote the standardized and orderly operation of the management system. The "Laboratory Accreditation Review Criteria" provides a concise introduction and requirements for them. Most laboratories have made significant progress in internal audit and supervision work, but some laboratories have issues such as low quality of internal audits and defects in supervision work. A few laboratories exhibit phenomena of coping with reviews or supervision inspections. Laboratories must pay attention and actively correct these issues, strengthen management, and further enhance the effectiveness of the management system operation.

Who is qualified to be an internal auditor? What are the characteristics?

1. Internal auditors should receive training from institutions qualified to provide internal auditor training. The "Laboratory Accreditation Review Criteria" (hereinafter referred to as the "Criteria") requires that "auditors should be trained and their qualifications confirmed. As long as resources permit, auditors should be independent of the work being audited." According to the original National Quality Supervision Bureau's "Quality System Internal Auditor Registration Management Measures," internal auditors apply individually, receive training from institutions qualified to provide internal auditor training, obtain a training certificate, and are registered and evaluated by a provincial quality supervision bureau-led evaluation committee. Training institutions refer to those approved by the National Quality Supervision Bureau as qualified to provide internal auditor training.

The effectiveness of training is mainly judged by the following three points:

(1) Training content meets the requirements of the CNAS internal auditor training syllabus;

(2) Training time is no less than 20 academic hours;

(3) After training, the internal auditor has the ability to conduct internal audits.

2. Internal auditors usually cannot audit their own activities unless it is proven necessary and it can be demonstrated that the audit conducted is effective.

The "Quality System Internal Auditor Registration Management Measures" stipulate that certification organizations must have at least two registered internal auditors who have passed training. The "Criteria" does not specify the number of internal auditors, but in smaller organizations, audits can be conducted by the quality manager themselves, which is justifiable. Of course, the manager should appoint other personnel to audit the quality manager's work to ensure that their quality responsibilities are fulfilled on schedule.

3. Internal auditors are rarely set up independently and are mostly part-time, holding other job positions. According to the "Criteria" regarding impartiality, independence, and confidentiality, they should not participate in internal audits of other similar laboratories. However, when other laboratories lack the capability and conditions to conduct internal audits, they may audit other laboratories or conduct second-party audits without being restricted by the CNAS-EL-01:2012 "Explanation of Several Requirements for Laboratory Accreditation Application Acceptance" clause stating "All personnel engaged in testing or calibration activities in the laboratory should be long-term fixed staff and are not allowed to engage in the same type of testing or calibration activities in other similar laboratories unless otherwise stipulated by laws, regulations, or CNAS requirements for specific fields."

What is the difference between an internal auditor and a quality supervisor?

The main differences between internal auditors and quality supervisors are as follows:

1. Different job nature: Internal auditors are generally employees holding internal auditor qualification certificates working part-time, while quality supervisors are full-time positions, usually selected from experienced quality inspectors or process technicians.

2. Different work scope: Internal auditors participate regularly (usually once a year, each time 3-5 days) in internal audits of the enterprise quality management system. Quality supervisors mainly conduct daily supervision of product quality to determine whether technical standards and production process disciplines are effectively implemented.

3. Different career development directions: Internal auditors' career paths include internal audit team leader, external auditor, and management representative; quality supervisors' career paths include quality administrator, quality technician, quality supervisor, and technical supervisor.

Who is qualified to be a quality supervisor?

The "Criteria" require laboratories to set up supervisors. Supervisors should be personnel familiar with various testing and/or calibration methods, procedures, purposes, and result evaluations, which is a requirement for the professional technical ability of supervisors.

1. Like internal auditors, supervisors are mostly part-time, and their main job should be as professional technical personnel. They only supervise the testing and/or calibration work of their department. They must be familiar with various testing and/or calibration methods, procedures, purposes, and result evaluations. They should have relatively strong business capabilities and rich work experience in the supervision field to better fulfill supervisory responsibilities.

2. Full-time management personnel and newly joined staff cannot competently serve as supervisors. Simply put, supervisors should have higher professional skills and judgment than general testing and/or calibration personnel. Comparatively, they implement supervision at a higher level or at least at the same level. This is especially evident in nondestructive testing laboratories.

Key objects of quality supervision

They should be testing personnel (including contracted personnel, additional technical personnel, and key support personnel), especially trainees, newly employed personnel, and short-term hired personnel. Effective and sufficient supervision must be implemented on them. Through effective supervision, work quality can be ensured.

Main supervision content of supervisors

In the ISO/IEC17025 standard "General requirements for the competence of testing and calibration laboratories," under "Technical Elements," "Personnel" is identified as the first factor determining the accuracy and reliability of laboratory testing. Strict requirements are placed on laboratory personnel regarding technical ability, experience, required professional knowledge, education and training, job responsibilities, and impartiality. Therefore, personnel are the most important factor. The main supervision content includes personnel qualifications and maintenance, familiarity with and execution of work instructions, compliance with inspection procedures/standards, equipment operation, conformity of environment and facilities, sample identification, sample preparation and configuration of reagents and consumables, sampling plans and execution (whether sampling plans are available on-site), verification of original records and data, data processing and judgment, uncertainty evaluation, and issuance of result reports.

How to achieve effective and sufficient supervision?

1. Supervisory personnel must have sufficient capability—they should have adequate professional knowledge. If conditions permit, it is best for higher-level personnel to supervise lower-level personnel. The conditions that supervisory personnel should meet are:

1. Familiarity with inspection methods such as "scope of application, principles, instruments, analysis steps, result calculations, relationships among multiple methods," etc. Example: Supervisor Engineer Li's supervision of instruments: "Engineer Li found that the calibration certificate (certificate number ××××××) for the gas chromatograph with serial number KA-020 did not include calibration data for the Electron Capture Detector (ECD), yet this detector was still used for routine testing of HCH and DDT in samples; determination: non-compliance with instrument calibration/verification requirements.

Cause analysis: Since the ECD and FPD detectors share one gas chromatograph, only the FPD detector was calibrated, and the ECD calibration was neglected. Corrective measures and implementation: The detector was sent for calibration. In the future, more detailed calibration/verification requirements should be proposed for instrument calibration.

2. Understand the purpose of inspection such as "evaluation (including product quality evaluation), supervision inspection, routine monitoring, quality control assessment including: blind sample assessment, operation demonstration, on-site questioning, sample retesting, personnel comparison, participation in proficiency testing, quality control charts, job rotation, etc." 

3. Understand the inspection procedures such as "sampling (or sample submission), subsampling, sample pretreatment, inspection, verification, re-examination, issuance, etc." Example: Quality control of drinking water sampling GB/T 5750.2-2006 "Standard Inspection Methods for Drinking Water - Collection and Preservation of Water Samples", the purpose of quality control in water sample collection: measures to prevent contamination or deterioration of water samples during collection. Quality control methods: field blanks, transport blanks, field parallel samples, field spiked samples or quality control samples, the entire sampling process must pay attention to quality control.

II. The number of supervisors must be sufficient — the ratio of supervisors to professional technical staff is generally between 1:5 and 1:10, and each type of testing project should have its own supervisors.

III. Supervisors must have sufficient authority — supervisors can point out problems on the spot and order immediate correction; when difficulties arise in handling nonconformities, they can report directly to the quality or technical manager for timely remedial actions; if necessary, they can withhold test reports; if unsatisfied with corrective measures, they can communicate with relevant personnel to propose improvement suggestions.

IV. The coverage of supervision must be sufficient — within one year (or one certification/accreditation cycle), supervision should cover all laboratory testing personnel, including contracted personnel, additional technical staff, and key support staff, especially trainees. 

V. Supervisors' work positions should facilitate supervision — temporary staff in special environments who have not received necessary training should work under the supervision of quality supervisors; sampling and testing at mobile laboratories, sampling sites, and field sites must be conducted under effective technical control and supervision.

Problems and solutions currently existing with internal auditors and supervisors

The "Guidelines" have been implemented for many years. Most laboratories emphasize learning laws, regulations, and the "Guidelines", continuously strengthen system construction, and operate management systems effectively, basically ensuring testing quality. However, many problems still exist in the work of internal auditors and supervisors. Comprehensive statistics from the National Certification and Accreditation Administration's special inspections from 2007 to 2012 show that problems related to internal auditors and supervisors have persisted:

1. In 2007: Some laboratories had incomplete internal audits during management system operation;

2. In 2008: Some laboratories could not sustain effective daily supervision; some had not started self-supervision; some internal audits did not focus on solving actual problems in system operation; some internal auditors had not received training on the assessment guidelines;

3. In 2009: Some laboratories had vague requirements for supervisors' work, with high arbitrariness and no clear supervision process or methods; unable to effectively identify problems in testing work; internal audits were unplanned and did not cover all elements of the "Laboratory Accreditation Assessment Guidelines" or the entire testing process; a few laboratories did not implement internal audits as required;

4. In 2010: The effectiveness of laboratory internal audits was notably insufficient;

5. In 2011: Many laboratories failed to conduct internal audits as planned; the scope of internal audits did not cover corresponding quality activities or departments; actual problems were not identified or corrected timely; a few laboratories conducted internal audits only to prepare materials for various assessments or supervision inspections; supervision work had insufficient staffing, lacked planning or operability, and problems found during supervision were not corrected according to relevant procedural documents.

6. In 2012 inspections, the clause with the highest nonconformity rate was "Appointment of supervisors in reasonable numbers and effective supervision work," with a nonconformity rate of 6.1%.

Therefore, in future work, efforts should continue to strengthen the promotion and study of the "Guidelines", improve personnel comprehensive quality, internal auditors should enhance their capabilities, truly understand internal audit and its process and purpose, ensure the authenticity and completeness of internal audit reports and records, and improve their quality. Supervisors should master professional knowledge in their supervision field, enrich themselves theoretically and experientially, and be able to grasp the entry points, weak points, and key points of supervision work.

Summary

The "Guidelines" require that "laboratories should have professional technical personnel and management personnel appropriate to their testing and/or calibration activities." This "appropriateness" can be understood as business quality, technical ability, and work experience meeting job needs, possessing certain professional ethics and moral cultivation, and having sufficient numbers to meet work demands. Laboratories should ensure internal auditors and supervisors have positions, duties, and responsibilities, avoid supervision and internal audits becoming mere formalities, passively accepting assessments and supervision. Internal auditors and supervisors should also improve their abilities and qualities to better play their respective roles and achieve the continuous and effective operation of the management system.