5.
Yes, the situation described could be considered a nonconformity according to ISO
9001:2015 standards. Let's break down the reasons:
1. Lack of Documented Procedures or Work Instructions:
ISO 9001:2015 requires organizations to establish and maintain documented
procedures or work instructions for processes essential to the effective
operation of the quality management system (QMS). In this case, while
statistical techniques are extensively used, the absence of documented
procedures or work instructions for their implementation represents a
deviation from this requirement.
2. Management's Claim of Employee Training:
While the management claimed that all employees were fully trained in the
use of statistical techniques and produced comprehensive training records,
ISO 9001:2015 also emphasizes the importance of ensuring that employees
are adequately trained to perform their assigned tasks. However, training
records alone may not suffice to demonstrate compliance if there is a lack of
documented procedures or work instructions guiding the use of statistical
techniques.
3. Demonstration of Correct Use of Statistical Techniques:
Although employees were able to explain and demonstrate the correct use of
statistical techniques, ISO 9001:2015 places importance on consistency and
standardization in processes. Without documented procedures or work
instructions, there may be inconsistencies or variations in the application of
statistical techniques, which could impact the reliability and effectiveness of
monitoring and measuring processes and products.
1. 10. Failure to Follow Work Instructions:
The operator did not follow the work instructions, which required all
operators to ground themselves using wrist-straps during the assembly
of the motherboard. This failure to adhere to established procedures
represents a deviation from the requirements outlined in the work
instructions.
2. Supervisor's Concession:
The supervisor's decision to exempt the operator from using wrist-straps
based on her claim of being allergic to them represents a deviation from
established procedures and compromises the effectiveness of the quality
management system. While accommodations may be made for legitimate
medical reasons, such concessions should be carefully evaluated and
documented to ensure they do not compromise product quality or safety.
3. Medical Certificate Provided:
The production of a medical certificate by the supervisor to support his
concession towards the operator indicates an attempt to justify the deviation
from established procedures. However, the acceptance of this certificate
without proper assessment or validation of its legitimacy may further
compound the nonconformity.
But it's easy to accidentally cause ESD damage when working on your project. Most
electronic components are damaged by electrostatic discharge during the assembly process.
Often this damage is caused due to a lack of grounding equipment (i.e. anti-static mats, ESD
wrist-straps, etc
11.
Yes, the situation described could be considered a nonconformity according to ISO
9001:2015 standards. Here's why:
1. Unauthorized Amendment to Procedure:
The handwritten amendment to the incoming acceptance procedure,
changing the original sample size from 50 to 80, was made without proper
authorization, documentation, or approval. ISO 9001:2015 requires
organizations to establish, implement, maintain, and continually improve a
quality management system, including documented procedures. Any
amendments or changes to documented procedures should be properly
reviewed, approved, and communicated to relevant personnel.
2. Lack of Date or Approval:
The amendment lacks a date or approval, indicating a lack of control over
changes to procedures. ISO 9001:2015 emphasizes the importance of ensuring
that documented information remains current and relevant by establishing
controls for the identification, review, and revision of documents. Changes to
documented procedures should be properly authorized, documented, and
communicated to ensure consistency and conformity with quality
management system requirements.
3. Quality Control Engineer's Claim of Initiative:
While the Quality Control Engineer claimed to have exercised his initiative to
correct what he perceived as a mistake, unauthorized changes to documented
procedures can introduce risks to product quality, consistency, and
compliance with customer requirements. ISO 9001:2015 requires organizations
to establish processes for identifying and addressing nonconformities and
taking corrective and preventive actions to prevent their recurrence.
4. Negligible Impact Claim:
The claim that the impact of the unapproved change was negligible does not
negate the fact that the change was made without proper authorization or
documentation. ISO 9001:2015 requires organizations to assess the potential
impact of changes to documented procedures and ensure that changes are
properly reviewed, approved, and communicated to prevent adverse effects
on product quality or customer satisfaction.
14.
Yes, the situation described could be considered a nonconformity according to ISO
9001:2015 standards. Here's why:
1. Nonconformity with Documented Procedures:
ISO 9001:2015 requires organizations to establish, implement, maintain, and
continually improve a quality management system, including documented
procedures for the retention of quality records. In this case, the retention
period for quality records was stipulated as three years, but some records
were kept for longer or shorter periods without proper justification or
documentation.
2. Lack of Consistency in Record Keeping:
Keeping some records for up to ten years while others for only six months
deviates from the stipulated retention period of three years and indicates
inconsistency in record-keeping practices. ISO 9001:2015 emphasizes the
importance of maintaining consistency in processes and procedures to ensure
the effective operation of the quality management system.
3. Management Representative's Explanation:
While the Management Representative claimed that some records required
longer retention periods while others required shorter periods, ISO 9001:2015
requires organizations to establish and maintain documented procedures for
determining the retention period of quality records based on their
significance, legal requirements, and business needs. The absence of such
documented procedures or justification for deviations from the stipulated
retention period represents a nonconformity.
4. Disregard for Record Keeping:
The Management Representative's claim that meticulous record-keeping
would be a waste of time and effort suggests a lack of commitment to
compliance with ISO 9001:2015 requirements. Proper record-keeping is
essential for traceability, accountability, and evidence of conformity to quality
management system requirements.
15. Internal audits can be accomplished by an internal employee or a 3rd Party, like
an ISO consultant
18. ISO 8.4.1 “The organization shall determine and apply criteria for the evaluation,
selection, monitoring of performance, and re-evaluation of external providers,”
20.
Precision machine parts are created with specialized tools and
equipment to meet the original design to the most accurate level.
Precision CNC machining creates parts with the tightest tolerances.
