Exam ISO-9001-Lead-Auditor Topic 6 Question 221 Discussion
Actual exam question for PECB's ISO-9001-Lead-Auditor exam
Question #: 221
Topic #: 6
Question #: 221
Topic #: 6
You are conducting an ISO 9001 audit of a Materials Recycling Facility (MRF). The company processes waste plastics into raw material for plastic bottle manufacturers. You reach the manual picking line where operators are removing contaminant materials from incoming products, such as plastic bags, plastic film and badly contaminated items that would compromise the recycling process.
You interview the line supervisor.
You: "Why are these plastic items being rejected at this stage?"
Auditee: "They do not meet our processing standards."
You: "What is the reason for that?"
Auditee: "These items are likely to damage the machinery down the line. They can also compromise our quality standards. We need to protect our reputation for good quality output materials." You: "What happens to the rejected items?" Auditee: "Some get melted down in another process later on and some are disposed of as waste products that cannot be recycled." You: "What happens to the waste products?" Auditee: "I'm not sure. I suppose they go to landfill." After further auditing, you have gathered additional evidence.
You interview the line supervisor.
You: "Why are these plastic items being rejected at this stage?"
Auditee: "They do not meet our processing standards."
You: "What is the reason for that?"
Auditee: "These items are likely to damage the machinery down the line. They can also compromise our quality standards. We need to protect our reputation for good quality output materials." You: "What happens to the rejected items?" Auditee: "Some get melted down in another process later on and some are disposed of as waste products that cannot be recycled." You: "What happens to the waste products?" Auditee: "I'm not sure. I suppose they go to landfill." After further auditing, you have gathered additional evidence.
Suggested Answer:
Explanation:
A # 8.4.3.a
B # 7.2.b
C # 10.2.2
D # 10.2.1
E # 6.2
Comprehensive and Detailed Explanation From Exact Extract:
# A. There is no specification for incoming materials # 8.4.3.a
Clause 8.4.3(a) relates to the control of externally provided processes, products, and services, specifically the requirement to communicate appropriate specifications and requirements to suppliers:
"The organization shall ensure the adequacy of requirements prior to their communication to the external provider." Failure to specify requirements for incoming materials (e.g., what is acceptable waste plastic) risks compromising product quality.
# B. The picking operators have been trained # 7.2.b
Clause 7.2(b) relates to Competence and mandates:
"Ensure that these persons are competent on the basis of appropriate education, training, or experience." Training is a critical part of establishing and maintaining operator competence in quality-affecting tasks.
# C. The picked reject materials are not documented # 10.2.2
This clause focuses on the retention of documented information regarding nonconformities and actions taken:
"The organization shall retain documented information as evidence of: the nature of the nonconformities and any subsequent actions taken..." If rejects are not recorded, traceability and root cause analysis for quality failures are weakened.
# D. The rejected materials are segregated # 10.2.1
Clause 10.2.1 relates to nonconformity and corrective action, including containment activities such as:
"Deal with nonconforming outputs in one or more of the following ways: correction; segregation, containment..." Segregation ensures nonconforming material doesn't contaminate acceptable output.
# E. Management has set an objective for the level of rejects # 6.2
Clause 6.2 is about quality objectives. It requires organizations to:
"Establish quality objectives at relevant functions... The quality objectives shall be measurable..." Setting a measurable reject-level target aligns with improving process control and reducing waste.
References:
ISO 9001:2015 Clause 8.4.3.a - Information for External Providers
ISO 9001:2015 Clause 7.2.b - Competence
ISO 9001:2015 Clause 10.2.2 - Documentation of Nonconformity
ISO 9001:2015 Clause 10.2.1 - Control of Nonconforming Outputs
ISO 9001:2015 Clause 6.2 - Quality Objectives
by Boris at Nov 04, 2025, 08:16 PM
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