Free Access PECB ISO-9001-Lead-Auditor New Release

Nonconformity report

ISO 9001 Clause Number: 8.5.4 Nature of problem: Cleaning and sanitising records are not available for every batch. ISO 9001 requirement that has not been fulfilled: ISO 9001 - “The organization shall implement planned arrangements, at appropriate stages, to verify that the product requirements have been met.” Evidence: 40 cleaning records are available for 63 batches.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 promotes the process approach, which allows organizations to structure their activities into interrelated processes. This approach helps ensure that processes effectively achieve intended results.

Clause 0.3.1 (Process Approach) states that "The application of the process approach in a quality management system enables understanding and consistency in meeting requirements, considering processes in terms of added value, and achieving effective process performance."

This aligns directly with option C, making it the correct answer. The other options are either partially correct or do not fully capture the purpose of the process approach:

Option A (Improvement based on interested parties) is a benefit but does not define the main goal.

Option B (Financial value) is not the primary focus of the process approach.

Option D (Reduction of resource consumption) may be an indirect benefit but is not a core objective.

The table below shows the possible matching of the ISO 9001 Clause 8.3 extract to the audit evidence.

Table

Audit evidence

ISO 9001 Clause 8.3 extract

Half of all new products launched in the past 12 months were late. The NPD Manager explains he has not got enough people on his team to cope with the demand for new products.

“8.3.2 e) … internal … resource needs for the design and development of products …”

The NPD Manager explains many changes are made to cosmetic formulations during product development owing to retailer feedback. Only when confirmed by the retailer is the agreed formulation documented on SWIFT.

“8.3.5 … retain documented information …”

The NPD Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails are kept on SWIFT.

“8.3.6 … retain documented information …”

The NPD Manager shows you evidence of consumer trials that are carried out for some new products prior to full-scale launch.

“8.3.4 d) … conducted to ensure that the resulting products and services meet the requirements …”

The NPD Manager explains that an approved external laboratory is used to perform shelf-life stability trials on some formulations during product development.

“8.3.2 e) … external … resource needs for the design and development of products …”

ISO 9001:2015 requires audits to be planned and conducted to ensure the quality management system conforms to requirements and is effectively implemented. While ISO 9001 sets the requirement, it explicitly refers auditors to ISO 19011 for detailed guidance on audit planning and execution.

ISO 9001:2015, Clause 9.2.2 (NOTE) states that guidance for auditing management systems is provided in ISO 19011 .

Based on ISO 19011:2018 (Clause 6.3 – Initiating and preparing for the audit), the audit team leader is responsible for finalising key planning issues before documenting the audit plan, especially for multi-site and multi-country audits.

Explanation of the selected options:

A. Arrangement of translation of the audit report

ISO 19011 requires consideration of communication and language arrangements during audit preparation. Where sites are located in different countries, potential language difficulties must be addressed during planning, including translation needs for reports and communications.

C. Structuring the audit plan to account for audit trails

ISO 19011 requires audits to follow audit trails across processes, functions, and interfaces. The audit plan must be structured to allow logical progression through interrelated processes, which must be decided before the plan is documented.

D. Determining available IT infrastructure for remote participation

ISO 19011 allows the use of remote auditing techniques. When audit team members are located in different countries, the audit team leader must confirm the availability of IT infrastructure to support remote participation in opening and closing meetings as part of audit planning.

E. Considering processes not operating at the time of the audit

ISO 19011 requires the audit team leader to consider process availability. If some processes are not operating during the audit period, alternative audit methods (such as records review or rescheduling) must be planned in advance and reflected in the audit plan.

Explanation of why the other options are not selected:

B: ISO 19011 requires identification of roles and functions to be audited, not specific names, at the audit planning stage.

F: Moderation or grading of nonconformities is performed after audit findings are raised, not during audit planning.

G: Post-audit communication arrangements are addressed during reporting and follow-up activities, not before documenting the audit plan.

H: Follow-up audits are planned only if required after audit results are known, not during initial audit planning.