Inglés para Gestión de Calidad: Vocabulario Esencial

"ISO 9001"

The international standard specifying requirements for a quality management system (QMS), focused on customer satisfaction and continual improvement.

"Our factory achieved ISO 9001 certification after a rigorous third-party audit of our QMS."

"quality management system (QMS)"

A formalised system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.

"The QMS defines how we handle customer complaints from receipt through to resolution."

"Total Quality Management (TQM)"

A management philosophy that involves every employee in the effort to improve quality, processes, and customer satisfaction across the entire organisation.

"Adopting TQM transformed the culture so that every department took ownership of quality outcomes."

"Six Sigma"

A data-driven methodology that aims to reduce defects and process variation to fewer than 3.4 defects per million opportunities.

"The Six Sigma project reduced the scrap rate on the production line from 4% to 0.2%."

"lean manufacturing"

A production methodology focused on eliminating waste and creating more value with fewer resources.

"Lean manufacturing principles helped cut the lead time for custom orders by 40%."

"DMAIC"

A Six Sigma problem-solving cycle standing for Define, Measure, Analyse, Improve, and Control.

"The team followed the DMAIC framework to systematically identify and eliminate the root cause of packaging defects."

"PDCA cycle"

The Plan-Do-Check-Act cycle, a four-step iterative model for continuous improvement of processes and products.

"We use the PDCA cycle every quarter to review supplier performance and implement corrective actions."

"benchmarking"

The process of comparing an organisation's processes and performance metrics against industry best practices or leading competitors.

"Benchmarking against the industry leader revealed that our on-time delivery rate lagged by 8 percentage points."

"statistical process control (SPC)"

The use of statistical methods to monitor and control a manufacturing or business process to ensure it operates at its full potential.

"Statistical process control charts flagged an upward drift in fill weights before any product left the line."

"control chart"

A graph used to study how a process changes over time, with upper and lower control limits to distinguish normal variation from special causes.

"The control chart showed the welding process was in statistical control with no points outside the limits."

"acceptance sampling"

An inspection procedure in which a sample from a lot is tested and the lot is accepted or rejected based on the sample results.

"Acceptance sampling of incoming components reduced inspection costs while maintaining a defect escape rate below 0.5%."

"inspection plan"

A documented set of instructions that specifies the characteristics to be inspected, the methods to be used, and the acceptance criteria.

"The inspection plan for medical devices required 100% dimensional checking of critical features."

"first article inspection (FAI)"

A formal examination of the first production part to verify that the manufacturing process can produce a part that meets all requirements.

"The customer required a first article inspection report before approving the new supplier for series production."

"gauge R&R (repeatability and reproducibility)"

A study that evaluates the variation in measurements produced by a measurement system to ensure it is fit for purpose.

"The gauge R&R study showed that measurement system variation accounted for only 8% of total observed variation, which is acceptable."

"non-conformance"

A product, service, or process that does not meet specified requirements or standards.

"The non-conformance report described the dimensional deviation and initiated the corrective action process."

"acceptance criteria"

The predefined standards or requirements that a product, service, or deliverable must meet before it is accepted.

"The acceptance criteria stated that surface roughness must not exceed 1.6 µm Ra on mating surfaces."

"kaizen"

A Japanese philosophy of continuous, incremental improvement involving all employees, from senior managers to front-line workers.

"A kaizen event on the assembly line reduced motion waste and cut cycle time by 15%."

"root cause analysis (RCA)"

A systematic process for identifying the fundamental reason a problem occurs so that the correct preventive action can be taken.

"Root cause analysis revealed that the recurring firmware failure stemmed from an unvalidated software update process."

"corrective action"

A step taken to eliminate the cause of a detected non-conformance or other undesirable situation to prevent its recurrence.

"The corrective action included retraining operators and updating the work instruction to prevent future errors."

"preventive action"

A step taken to eliminate the cause of a potential non-conformance before it occurs.

"As a preventive action, the team installed automated torque verification to avoid under-tightening in future runs."

"five whys"

An iterative interrogative technique used to explore the cause-and-effect relationships underlying a problem by asking "why" five times.

"Using the five whys, the team traced a delivery delay back to an inaccurate demand forecast in the planning system."

"8D report"

An eight-discipline problem-solving methodology that documents the steps taken to identify, correct, and prevent the recurrence of a quality problem.

"The customer required a completed 8D report within ten working days of the field failure notification."

"poka-yoke"

A mistake-proofing device or method that prevents errors from occurring or immediately detects them if they do.

"Installing a poka-yoke sensor on the press eliminated the risk of parts being loaded in the wrong orientation."

"value stream mapping"

A lean technique for visualising all the steps in a process to identify waste and opportunities for improvement.

"Value stream mapping exposed three handover delays that together added two days to the order-to-ship cycle."

"audit trail"

A sequential record of all activities related to a process, product, or transaction, enabling traceability from start to finish.

"The electronic audit trail in the batch record showed every step of the manufacturing process and who approved it."

"internal audit"

An independent evaluation conducted within an organisation to assess the effectiveness of its QMS and identify improvement opportunities.

"The internal audit programme schedules each process area for review at least once every twelve months."

"third-party audit"

An independent assessment performed by an external body, such as a certification body, to verify conformance to a standard or regulation.

"A third-party audit by the certification body confirmed that the site remained compliant with ISO 9001."

"audit finding"

A documented observation from an audit that identifies a non-conformance, an opportunity for improvement, or a positive practice.

"The audit finding cited missing calibration records for three measuring instruments as a minor non-conformance."

"corrective action plan (CAP)"

A document that describes the steps an organisation will take to address the root cause of audit findings and prevent recurrence.

"Management submitted a corrective action plan within 30 days of receiving the audit report."

"supplier qualification"

The process of evaluating and approving a new supplier to confirm they meet the required quality, technical, and compliance standards.

"Supplier qualification included an on-site audit, sample testing, and a review of the supplier's quality documentation."

"regulatory compliance"

Adherence to laws, regulations, guidelines, and specifications relevant to an organisation's operations and industry sector.

"The quality director confirmed that regulatory compliance with FDA 21 CFR Part 11 was verified during the annual audit."

"observation (audit)"

An audit comment that notes a potential weakness or area at risk of non-conformance, without constituting a formal finding.

"The auditor raised an observation that document revision dates were inconsistently formatted across different departments."

"defect rate"

The proportion of units produced that do not meet quality specifications, usually expressed as parts per million (PPM) or as a percentage.

"The defect rate fell from 1,200 PPM to 350 PPM after the new pressing tool was installed."

"first pass yield (FPY)"

The percentage of units that complete a process meeting all quality specifications without any rework or repair.

"First pass yield on the circuit board assembly line improved from 87% to 96% after the soldering profile was optimised."

"cost of quality (CoQ)"

The total cost incurred to prevent defects, appraise quality, and address failures, comprising prevention, appraisal, internal failure, and external failure costs.

"A cost of quality analysis showed that external failure costs — warranty and returns — were five times higher than prevention spending."

"customer complaint rate"

The number of formal complaints received from customers per unit sold or delivered, used to track perceived quality performance.

"The new packaging design reduced the customer complaint rate for transit damage by 60%."

"on-time delivery (OTD)"

The percentage of orders or shipments delivered to the customer by the agreed date, a key indicator of operational and quality reliability.

"On-time delivery dropped to 82% during the component shortage, prompting an emergency supplier review."

"process capability index (Cpk)"

A statistical measure of how well a process produces output within specification limits, accounting for both process variation and centring.

"A Cpk of 1.67 confirmed that the milling process had sufficient capability to meet the tight dimensional tolerances."

"mean time between failures (MTBF)"

The average time elapsed between one failure and the next for a repairable system, used as an indicator of reliability.

"After replacing the bearings, the MTBF of the conveyor system increased from 800 to 2,400 hours."

"customer satisfaction score (CSAT)"

A metric that measures how satisfied customers are with a product, service, or interaction, typically gathered through surveys.

"The CSAT survey showed a 12-point improvement following the introduction of the new technical support process."

"document control"

A systematic process for managing quality documents, including creation, review, approval, distribution, revision, and obsolescence.

"Document control procedures ensure that only the current approved version of a work instruction is available on the shop floor."

"failure mode and effects analysis (FMEA)"

A structured technique for identifying potential failure modes in a process or product, assessing their effects, and prioritising corrective actions.

"The FMEA identified a high-risk failure mode in the sealing step and led to the addition of a 100% leak test."

"risk priority number (RPN)"

A numerical score in FMEA calculated by multiplying the severity, occurrence, and detectability ratings of a failure mode to prioritise corrective actions.

"Failure modes with an RPN above 100 were immediately escalated to the engineering team for corrective action."

"design validation"

Testing performed to confirm that a product or system meets the needs of the user and its intended use in the real environment.

"Design validation included field trials with 50 users to confirm the device performed correctly under actual conditions of use."

"design verification"

Testing or analysis performed to confirm that a design output meets the design input requirements.

"Design verification tests confirmed that the assembly met all dimensional, functional, and load-bearing specifications."

"change control"

A formal process for managing modifications to a product, process, document, or system to ensure changes are evaluated, approved, and implemented correctly.

"Any change to a critical process parameter must go through the change control procedure before being implemented in production."

"traceability"

The ability to track the history, application, or location of a product, component, or material through the supply chain and production process.

"Full traceability of raw material batch numbers allowed the company to execute a targeted recall within 24 hours."

"validation protocol"

A written plan that describes how a validation study will be conducted, including the test methods, acceptance criteria, and responsibilities.

"The validation protocol for the sterilisation process specified three consecutive successful runs at the worst-case conditions."