[Certification Class] Things About Nonconformities Found During Audits

Nonconformity Report

Meaning of Nonconformities:

The nonconformities referred to in the audit mean "requirements not met." The main specified requirements here include:

(1) Standard requirements (taking 9001 as an example, such as ISO9001 standard requirements).

(2) Document requirements (including quality manual, procedure documents, quality records, quality plans, or technical and management documents).

(3) Contract requirements (sales contracts signed with customers, purchase contracts signed with suppliers, etc.).

(4) Social requirements (including laws, regulations, decrees, rules, and obligations related to environmental protection, health and safety, energy, and natural resource conservation).

(5) Other requirements, such as top management's demands, common-sense requirements (not necessarily documented).

(6) Customer complaints.

The determination of nonconformities is based on the explicit requirements of the ISO9001:2015 standard and customer complaints. Nonconformities related to implicit requirements can be described as observations or appropriately detailed in the audit report.

Principles for Determining Nonconformities

Principle based on objective evidence

Nonconformities cannot be determined without sufficient evidence. For nonconformities disputed by the auditee, decisions can be made through negotiation or re-audit.

Classification and Evaluation of Nonconformities

Internal quality management system audits can classify nonconformities into four levels by severity: major nonconformity, general nonconformity, minor nonconformity, and observation.

(1) Major Nonconformity

Major nonconformity usually refers to systemic failure/regional failure or defects causing serious consequences. The main criteria include:

① Serious inconsistency between the quality management system and the agreed quality management system standards or documents. For example, key control procedures are not implemented, or required standards are missing.

② Nonconformities causing systemic failure (may require multiple general nonconformities to explain). For example, most measuring and monitoring equipment in use is not calibrated (verified) on schedule, or most nonconforming products are not reviewed and recorded as required.

③ Nonconformities causing regional failure (may require multiple general nonconformities to explain). For example, a certain organizational unit is not covered by the quality management system or the unit does not implement the system as required, or among all products covered by the quality management system, a certain product is not controlled according to standards.

④ Nonconformities that may cause serious consequences. For example, welding of pressure vessels does not meet specified requirements, household appliances have not undergone insulation or pressure tests, or processing is done according to incorrect drawings. These directly endanger product or personal safety or may cause significant economic loss and seriously damage the organization's reputation.

⑤ Nonconformities violating laws and regulations.

(2) General Nonconformity

Criteria for general nonconformities:

① Not occasional, obvious nonconformities with document requirements. For example, some purchase contracts are not reviewed, or inspectors' responsibilities are unclear.

② Nonconformities directly affecting product quality. For example, several testing devices have exceeded calibration periods and initial or self-inspections are not performed as required.

③ Nonconformities causing failure of quality activities. For example, quality control points do not control key quality characteristics or process influencing factors.

(3) Minor Nonconformity

Minor nonconformities refer to isolated, occasional issues that do not directly affect product quality. For example, a drawing or a document version in the file is not the latest, a document lacks a date, inaccurate wording, or signatures do not meet requirements.

(4) Observation

Classifying nonconformities can sometimes be difficult because boundaries are hard to define precisely. This distinction often depends on the experience and skills of the audit team leader and auditors. Sometimes a report similar to a nonconformity is called an "observation." Situations for "observations" mainly include:

① Slightly insufficient evidence, but issues exist that need to be reminded.

② Problems found that do not yet constitute nonconformities but could develop into nonconformities.

③ Other matters requiring attention.

Observation reports are not nonconformity reports and are not included in the final audit report. The setting of "observations" undoubtedly provides a step for both the auditor and auditee, which helps ease the audit atmosphere. Proper use has positive significance for internal audits.

Contents of Nonconformity Reports

Contents of nonconformity reports may include: auditee name, auditor, accompanying personnel, date, description of nonconformity (objective facts of nonconformity or defects), conclusion of nonconformity (violated standard or document clauses), nature of nonconformity (by severity), auditee confirmation, corrective actions and completion time, verification records after corrective actions, etc. The three essential elements of a nonconformity report are: description of nonconformity, conclusion of nonconformity, and nature of nonconformity; these are indispensable for any nonconformity report.

The description of nonconformity should strictly cite objective evidence and be traceable. For example, observed facts, locations, persons involved, related document numbers, product batch numbers, relevant document content, statements from related personnel, etc. The description should be as simple and clear as possible, factual, straightforward, and unembellished.

The conclusion of nonconformity mainly refers to which clause of the agreed documents (quality management system standards, quality management system documents, contracts, etc.) the described phenomenon violates.

Information source: Internet