ISO 13485:2016 clause 6: Resource management

• Resource management overview documentation -- verify the organization has a systematic approach to determining, providing, and maintaining resources across all three sub-areas: human resources, infrastructure, and work environment
• Resource planning process -- look for an annual or periodic resource assessment that evaluates current versus needed resources across competency, infrastructure, and environment
• Management review resource outputs (5.6.3d) traced to actual provision -- verify resource decisions from management review resulted in actual resource allocation, not just paper commitments
• Resource adequacy indicators -- look for metrics showing whether current resources are sufficient (vacancy rates, equipment uptime, environmental compliance rates)
• Budget allocation records showing resources dedicated to QMS maintenance -- verify quality-related resources have protected budgets not subject to arbitrary reallocation

• No systematic resource determination process exists -- resources are allocated reactively when problems arise rather than proactively based on assessment of needs (Minor NC)
• Resource decisions from management review are not implemented -- approved positions remain unfilled for an extended period with no recruiting activity (Minor NC)
• Resource planning covers human resources but not infrastructure or work environment -- facility aging, equipment obsolescence, and environmental control degradation are not systematically assessed (Minor NC)
• Quality department budget was reduced mid-year by 30% to offset production cost overruns -- resource provision is not maintained when financial pressure increases (Minor NC)

Review the overall resource management approach and check 3 lagging indicators (CAPA aging, audit schedule compliance, calibration currency) as proxies for resource adequacy.

• What resource gap has the most significant impact on QMS effectiveness right now?
• How does the organization balance resource allocation between production demands and QMS requirements?
• When was the last time a significant quality event was traced back to insufficient resources?

• Resource needs assessment or analysis -- verify a systematic evaluation of required versus available resources across human resources, infrastructure, work environment, and financial resources, conducted at least annually
• Management review inputs on resource needs -- verify resource discussions in management review are based on data (workload analysis, capacity studies, competency gap analysis) not just opinions
• Resource gap register -- look for a documented list of identified resource shortfalls with prioritization, closure plans, and timeline commitments
• Budget allocation records -- verify quality-related budget requests are documented with justification and that approved budgets are actually disbursed
• Staffing analysis -- verify headcount for quality-affecting roles is assessed against workload requirements, not just set at historical levels
• Capacity planning -- verify equipment and infrastructure capacity are assessed against current and projected production volumes

• No formal resource determination process exists -- resources are requested ad-hoc when problems arise rather than systematically assessed against QMS needs (Minor NC)
• Resource determination is performed for production operations but not for QMS support functions (internal audit, CAPA, document control, training) -- quality department resources are set by historical precedent rather than workload analysis (Minor NC)
• Resource assessment identified a need for additional quality inspectors but only a fraction have been hired -- determination occurred but provision did not follow (Minor NC)
• No capacity planning for critical equipment -- aging test equipment operates at near-maximum utilization with no plan for replacement or expansion despite projected production growth (Minor NC)
• Resource determination does not consider regulatory changes -- the EU MDR transition requires significant additional documentation and testing resources that have not been assessed (Minor NC)

Review the most recent resource needs assessment. Select 3 identified needs and verify whether resources were actually provided. Check 2 outcome indicators (CAPA aging, audit schedule compliance) as validation.

• How often is the resource needs assessment updated, and who participates in it?
• What percentage of identified resource needs from the last assessment have been fully provided?
• Show me a resource gap that was identified but not yet closed -- what is the impact on the QMS?

• Quality department budget breakdown -- verify dedicated funding for internal audits, CAPA investigations, document control, training programs, supplier audits, and management review preparation
• Staffing plan for quality functions -- verify headcount is based on workload analysis and that current positions are filled; check time-to-fill for vacant quality positions
• Internal audit program resources -- verify sufficient trained auditors exist to complete the audit schedule without deferring or cancelling planned audits
• CAPA investigation capacity -- verify resources exist to investigate, implement, and verify corrective actions within defined timelines; check CAPA aging as a resource adequacy indicator
• Document control system resources -- verify the document control system (electronic or paper) is adequately staffed and maintained to handle document volume and revision frequency
• Training program resources -- verify training budget and personnel are sufficient to deliver required training on schedule including GMP training, SOP training, and competency assessments

• Quality department has multiple unfilled positions for an extended period, resulting in a CAPA backlog and cancelled internal audits -- resources are not maintained (Major NC)
• No dedicated budget line item exists for internal audits -- auditors must justify each audit engagement individually, and several planned audits were cancelled due to budget constraints (Minor NC)
• Document control system is a shared network drive with no dedicated administrator -- document reviews are backlogged 4 weeks due to insufficient resources for the document control process (Minor NC)
• Training program relies entirely on on-the-job training with no budget for external courses, certifications, or training material development -- training effectiveness is limited by resource constraints (Minor NC)
• Quality manager performs dual roles as quality manager and regulatory affairs manager, leaving insufficient time for either function -- quality system oversight is compromised by competing priorities (Minor NC)

Review the quality department budget and staffing plan. Check 3 resource adequacy indicators: CAPA aging trend, internal audit schedule completion rate, and training completion rate.

• If you could add one resource to improve QMS effectiveness, what would it be?
• How much quality staff time is spent on planned QMS activities versus reactive problem-solving?
• Show me the training budget for this year -- what percentage has been spent, and what is deferred?

• Regulatory affairs department staffing and budget -- verify sufficient resources exist for regulatory submissions, correspondence, and compliance monitoring across all applicable jurisdictions
• Testing and validation laboratory resources -- verify lab capacity (equipment, personnel, calibration) is sufficient for required product testing, design verification/validation, and process validation
• Regulatory submission pipeline -- verify submission timelines are achievable with current resources; check for delayed or overdue submissions as indicators of resource insufficiency
• Customer requirement fulfillment tracking -- verify the organization can demonstrate it has resources to meet customer-specific requirements (delivery times, documentation, testing)
• Certification and compliance maintenance -- verify resources are allocated for maintaining existing certifications (ISO 13485, CE marking, FDA registration) including surveillance audit preparation

• Regulatory affairs function is performed by a single part-time specialist covering multiple jurisdictions -- a recent regulatory submission was significantly delayed due to resource constraints (Minor NC)
• Testing laboratory has a 6-week backlog for design verification testing due to equipment capacity limitations -- new product introduction timelines are being extended because of resource constraints (Minor NC)
• No resources have been allocated for EU MDR clinical evaluation report (CER) updates despite this being a mandatory regulatory requirement -- the organization acknowledges the obligation but has not provided resources to fulfill it (Major NC)
• Customer contracts specify a defined complaint response time but the organization consistently exceeds it -- insufficient customer support resources prevent meeting customer requirements (Minor NC)
• Notified body surveillance audit preparation is performed reactively in the 2 weeks before the audit rather than through ongoing compliance maintenance -- resources are not allocated for continuous regulatory readiness (Minor NC)

Review regulatory affairs staffing and budget against jurisdiction count. Check regulatory submission timeline adherence for the last 6 months. Verify customer SLA performance for 2 key customer requirements.

• Are there any regulatory submissions currently delayed due to resource constraints?
• How do you determine the resource level needed for regulatory affairs given your multi-jurisdiction obligations?
• Show me evidence that customer SLA requirements (response times, documentation) are consistently being met.

• Competency matrix or skills matrix -- verify it covers ALL roles that affect product quality (production, quality, design, purchasing, warehousing, sterilization, packaging, service, regulatory) with required competencies for each
• Personnel files for sampled employees -- verify each file contains evidence of appropriate education, training completion records, skills assessment results, and relevant experience documentation
• Scope definition of 'work affecting product quality' -- verify the organization has identified which roles affect quality; this scope should be broad including indirect roles like IT (system validation), purchasing (supplier selection), and facilities (environmental control)
• Competency gap analysis -- verify the organization periodically assesses actual competency against requirements and identifies gaps for closure
• Competency verification methods -- verify the organization uses appropriate methods to confirm competency (written tests, practical demonstrations, supervised performance, portfolio review) rather than relying solely on training attendance

• Competency requirements are defined only for production and quality roles -- design engineers, purchasing agents, warehouse personnel, and IT administrators have no defined competency requirements despite their work directly affecting product quality (Major NC)
• A final inspection operator has been performing critical visual inspections for an extended period with no documented competency assessment -- their personnel file contains only a new-hire orientation record (Major NC)
• Competency is equated with training attendance -- completing a 2-hour training session is treated as proof of competency with no assessment of whether the person can actually perform the task correctly (Minor NC)
• Temporary staffing agency personnel work on the production line assembling Class II medical devices but are excluded from the competency management system -- their qualifications are not verified (Major NC)
• Competency matrix was created during initial ISO 13485 certification and has not been updated despite the addition of new product lines requiring new technical competencies (Minor NC)

Sample 5 personnel files from different departments: 2 production operators, 1 quality inspector, 1 design engineer, 1 purchasing agent. For each, verify defined competency requirements and evidence of education, training, skills, and experience.

• How do you determine whether a new role or a changed role requires updated competency requirements?
• Show me how competency is verified for temporary or contract workers who perform production tasks.
• What happens if a competency assessment reveals an employee is not competent for their current role?

• Training and competency management procedure/SOP -- verify it defines the complete lifecycle: competency determination, gap analysis, training provision, effectiveness evaluation, awareness activities, record maintenance, and requalification triggers
• New employee onboarding process -- verify documented steps for verifying initial competency (education, experience), providing role-specific training, assessing competency before independent work, and documenting all activities
• Requalification procedure -- verify documented triggers for when competency must be reassessed (procedure changes, new equipment, extended absence, error events) and the requalification method
• Training needs identification process -- verify a systematic method for identifying training needs beyond initial onboarding (annual competency reviews, regulatory updates, process changes, audit findings)
• Awareness program procedure -- verify documented activities to ensure personnel understand the relevance of their work to quality objectives

• No documented training and competency procedure exists -- training is managed informally by department supervisors with no standardized approach to competency assessment or record-keeping (Major NC)
• Procedure addresses initial training for new hires but contains no provisions for requalification when procedures change -- operators trained years ago on a procedure that has been revised multiple times since have no retraining records (Minor NC)
• Awareness activities are not documented in any procedure -- the organization has no defined process for ensuring personnel understand how their work contributes to quality objectives (Minor NC)
• Training needs identification is ad-hoc -- there is no defined process for periodically assessing whether current training is sufficient or whether new training is needed based on changes in processes, regulations, or products (Minor NC)
• The procedure defines training responsibilities but not competency assessment methods -- it states 'supervisor will verify competency' without defining how (written test, practical demonstration, observed performance period) (Minor NC)

Review the documented process. Select 2 recent new hires and trace their competency journey through the process from onboarding to independent work authorization. Select 1 recent procedure change and verify requalification was triggered.

• What triggers requalification of a trained operator -- what events require reassessment of competency?
• How does the process differ for high-risk roles (cleanroom operators, sterilization technicians) versus lower-risk roles?
• Show me how the training needs identification process works for an annual cycle -- what data inputs drive the training plan?

• Role-specific competency requirements document -- verify each quality-affecting role has defined requirements covering education level, training topics with proficiency levels, specific skills (visual acuity, manual dexterity, statistical analysis), and minimum experience
• Justification for competency requirements -- verify requirements are based on the role's impact on product quality and regulatory requirements, not just copied from generic job posting templates
• Regulatory-driven competency requirements -- verify roles with regulatory obligations have those requirements explicitly captured (e.g., internal auditors must meet ISO 19011 competency, sterilization operators must understand ISO 11135/11137)
• Critical role identification -- verify the organization has identified which roles have the highest impact on product safety and defined correspondingly rigorous competency requirements
• Competency requirement review process -- verify requirements are periodically reviewed and updated when processes, products, or regulations change

• Competency requirements for production operators are generic across all product lines despite significant differences in complexity and risk -- the same requirements apply whether assembling a Class I bandage or a Class III implantable device (Minor NC)
• No competency requirements exist for internal auditors beyond 'completed lead auditor training' -- ISO 19011 Clause 7 competency requirements (personal attributes, knowledge, skills) are not addressed (Minor NC)
• Requirements specify 'relevant experience' without defining what constitutes relevant or how much is needed -- a new graduate and a 20-year veteran meet the same vague requirement (Minor NC)
• Visual inspection competency requirements do not include visual acuity testing despite the role requiring detection of sub-millimeter defects on medical device components (Minor NC)
• Competency requirements have not been updated since 3 new product families were added, each requiring specialized technical knowledge not captured in existing requirements (Minor NC)

Select 3 roles of different risk levels (high: final inspector, medium: production operator, low: warehouse handler). Compare competency requirements for risk-proportionate rigor. Verify all 4 elements (education, training, skills, experience) are defined for each.

• How does the competency requirement differ between an operator on a Class I device line versus a Class III device line?
• What specific skills are required for final inspection beyond general training -- visual acuity, measurement technique, defect identification?
• When was the last time competency requirements were updated, and what triggered the update?

• Training plans linked to identified competency gaps -- verify each identified gap has a corresponding action plan with timelines and responsible persons
• Training completion records for gap closure -- verify training was delivered on time and covered the specific competency gap, not just general awareness
• Alternative competency actions -- look for evidence of actions beyond training: hiring qualified replacements, mentoring programs, job rotation for skill development, or engaging consultants for specialized expertise
• Interim measures during gap period -- verify the organization defines what the person can and cannot do while the competency gap exists (supervised only, restricted tasks, no independent work on specific activities)
• Refresher training schedules -- verify ongoing maintenance of competency through periodic retraining, not just initial qualification

• Competency gap in aseptic technique was identified for cleanroom operators but training has not been scheduled -- the operators continue to work in the cleanroom unsupervised during the gap period (Major NC)
• All competency gaps are addressed with 'read and understand' training (reading the SOP and signing) regardless of the complexity of the competency -- practical skill gaps require practical training, not just reading (Minor NC)
• No interim restrictions are placed on personnel with identified competency gaps -- an operator found to be non-competent in a specific inspection technique continued performing that inspection unsupervised pending retraining (Major NC)
• Refresher training is not performed -- initial qualification training from years ago is the most recent competency evidence for long-tenured employees (Minor NC)
• Training is provided but no follow-up assessment confirms the gap was actually closed -- the organization assumes training = competency without verification (Minor NC)

Select 3 employees with recent training records. For each, verify the training was linked to an identified competency need, delivered on time, and followed by competency verification. Check 1 case where a gap was identified to verify interim restrictions during the gap period.

• What restrictions are placed on an employee while a competency gap is being closed?
• Show me an example where training alone was insufficient to close a competency gap -- what other actions were taken?
• How do you determine the appropriate refresher training interval for different competencies?

• Training effectiveness evaluation records -- verify evaluations go beyond attendance confirmation to assess actual competency achievement through tests, demonstrations, or performance measurement
• Evaluation methods proportionate to risk -- verify high-risk activities (sterilization, final inspection, aseptic processing) have more rigorous effectiveness evaluations than low-risk activities
• Post-training performance data -- look for measurable improvements (error rate reduction, yield improvement, cycle time consistency) as evidence that training achieved its intended purpose
• Failed effectiveness evaluations -- verify the organization has a process for what happens when training is found to be ineffective (retraining, alternative methods, personnel reassignment)
• Supervisor competency sign-off records -- verify supervisors formally attest to an employee's demonstrated competency after training, based on observed performance

• Training effectiveness is evaluated solely by a post-training quiz with a 70% pass threshold -- a written quiz cannot verify practical skills like aseptic gowning technique, measurement instrument operation, or visual defect identification (Minor NC)
• No effectiveness evaluation was performed for any training events in the review period -- training records show attendance only, with no verification that any training achieved its purpose (Major NC)
• Same evaluation method (5-question quiz) is used for all training regardless of risk -- the evaluation for GMP awareness training and the evaluation for cleanroom gowning qualification are identical in rigor (Minor NC)
• An operator failed the post-training practical assessment but was permitted to continue working independently while awaiting retraining -- the failed evaluation should have triggered interim restrictions (Major NC)
• Effectiveness evaluation is performed immediately after training but never followed up -- there is no check at 30, 60, or 90 days to verify that competency is retained in practice (Observation)

Select 4 training events: 2 high-risk (production, inspection) and 2 lower-risk (administrative, awareness). For each, verify the effectiveness evaluation method was proportionate to risk and that results were documented. Check 1 case where evaluation showed the training was not effective.

• What is the training effectiveness evaluation failure rate, and what triggers when someone fails?
• Show me the effectiveness evaluation method for your highest-risk training activity -- how was this method validated?
• How soon after training is effectiveness evaluated, and is there any delayed follow-up to verify retention?

• Quality awareness training records -- verify all personnel received training on quality objectives, the relevance of their role, and how their activities contribute to product quality and patient safety
• Department-level quality objective communication -- verify each department has visible quality objectives or performance targets that employees can reference
• Employee awareness assessment results -- verify the organization has assessed understanding through interviews, surveys, or quizzes, not just assumed awareness from training attendance
• Visual management boards -- look for quality metrics, objectives, and performance data displayed in work areas where employees can see them daily
• Recognition program evidence -- look for programs that recognize quality contributions, reinforcing the message that quality is valued

• When interviewed, a majority of production operators could not explain how their work contributes to quality objectives or why specific procedures exist -- they perform tasks by rote without understanding the quality purpose (Minor NC)
• Quality objectives are posted in the quality department conference room but not in production areas -- operators have no visibility to the objectives they are supposed to support (Minor NC)
• Awareness training consists of reading the quality policy and signing an acknowledgment form -- there is no explanation of how individual roles connect to quality objectives or why compliance matters (Minor NC)
• Warehouse staff do not understand why FIFO is a quality requirement and cannot explain the connection between inventory management and product traceability -- their awareness training did not cover the 'why' behind procedures (Minor NC)

Interview 4 employees from different departments and levels. For each, assess understanding of (1) their role's relevance to quality, (2) how they contribute to quality objectives, and (3) why quality and regulatory compliance matter. Grade as strong, adequate, or insufficient understanding.

• What would happen to the product or the patient if you did not follow your most important quality procedure?
• What quality objective does your department contribute to, and how is your contribution measured?
• How does the organization help you understand why quality procedures exist, not just what they require?

• Training records management system -- verify the system (electronic LMS or paper files) provides complete, organized records retrievable by employee, by training topic, or by department
• Sample personnel files -- pull 5 files and verify each contains: education verification (diploma, degree, transcripts), training completion records with dates and signatures, skills assessment results, experience verification, and competency certifications
• Record retention compliance -- verify training records are retained per the 4.2.5 retention schedule and that retention periods meet regulatory requirements (FDA typically expects lifetime of device + 2 years)
• Record completeness audit -- verify the organization periodically audits training records for completeness and addresses gaps
• Electronic record backup and security -- for electronic systems, verify backup procedures, access controls, and data integrity measures per 21 CFR Part 11 principles where applicable

• Several sampled personnel files are missing education verification documents -- the organization accepted self-reported education without verification for employees hired before the current HR manager (Minor NC)
• Training records for a cleanroom operator show GMP training completion in 2022 but no record of any training since, despite 3 SOP revisions and a new product line introduction -- records do not demonstrate ongoing competency maintenance (Minor NC)
• Paper training records are stored in an unlocked filing cabinet with no backup copies -- if the cabinet were destroyed, all training records would be lost, violating 4.2.5 requirements for record protection (Minor NC)
• Electronic training management system was implemented but records for employees hired before the system was deployed were not migrated -- a parallel paper system still exists with inconsistent record-keeping (Minor NC)
• Records show training attendance but not competency assessment results -- there is no way to determine from the records whether the training was effective or whether the person is competent (Minor NC)
• Training records for contract workers who performed assembly work for an extended period cannot be located -- the contractor's training records were not maintained by the organization (Major NC)

Pull complete personnel/training files for 5 employees: 1 new hire (less than 6 months), 2 production operators (1 long-tenured), 1 quality inspector, and 1 temporary/contract worker. Verify completeness of education, training, skills, and experience records for each.

• How long does it take to produce a complete competency file for any employee on request?
• What is your record retention period for training records, and how was it determined?
• Show me the training records for a contract worker who performed production work in the last 6 months.

• Infrastructure master list or asset register -- verify it covers all three categories: buildings/workspace/utilities, process equipment (hardware and software), and supporting services; check that the list is current and includes asset condition, qualification status, and criticality rating
• Infrastructure planning linked to product requirements -- verify the organization determines infrastructure needs based on design outputs, process validation requirements, and regulatory specifications, not just historical availability
• Infrastructure qualification records (IQ/OQ/PQ) -- for equipment used in validated processes, verify qualification protocols and results are current and the equipment is operating within qualified parameters
• Infrastructure gap assessment -- look for periodic evaluation of whether current infrastructure is adequate for current and projected needs, including capacity utilization and equipment age/obsolescence analysis
• Capital planning and investment records -- verify infrastructure investments are planned based on identified needs with approved budgets and implementation timelines
• Facility tour observations -- compare actual conditions against documentation during the physical walkthrough

• Infrastructure master list has not been updated for an extended period and does not include equipment added during a production line expansion or a recently commissioned warehouse facility (Minor NC)
• Equipment used in validated sealing processes has not been requalified after relocation to a new production area -- the original IQ/OQ/PQ was performed at the previous location with different utilities and environmental conditions (Major NC)
• No infrastructure planning or capacity analysis exists -- the organization operates reactively, purchasing equipment only when existing equipment fails or production bottlenecks occur (Minor NC)
• Software used for production scheduling and inventory management is not included in the infrastructure register and has never been validated despite directly affecting product traceability (Minor NC)
• Facility tour reveals a production area with visible water damage on the ceiling above an open packaging line -- the facilities maintenance log shows the issue was reported months ago but not repaired (Major NC)

Review the infrastructure master list. During the facility tour, spot-check 5 pieces of equipment for qualification status, maintenance currency, and calibration. Verify 2 pieces of software are included in the infrastructure register.

• How do you determine when equipment needs to be replaced versus continued with increased maintenance?
• What is the average age of your critical production equipment, and what is the replacement plan?
• Show me the most recent infrastructure investment that was driven by a quality or regulatory requirement rather than a production volume increase.

• Documented maintenance procedure -- verify it defines maintenance requirements, frequencies, responsibilities, and record-keeping for all equipment where maintenance affects product quality
• Maintenance schedule with defined frequencies -- verify frequencies are justified (manufacturer recommendations, reliability analysis, or risk-based determination) and that the schedule distinguishes between critical and non-critical equipment
• Critical equipment identification -- verify the organization has determined which equipment maintenance directly affects product quality and prioritized these for preventive maintenance
• Preventive maintenance work orders and records -- verify work orders define specific maintenance activities (not just 'perform PM'), include acceptance criteria, and are completed on schedule
• Maintenance interval justification -- verify frequencies are based on manufacturer recommendations, equipment reliability data, process validation requirements, or documented risk assessment

• No documented maintenance requirements exist for the automated labeling system despite label accuracy being a critical quality attribute -- the equipment is maintained only when it malfunctions (Major NC when labeling errors have patient safety implications)
• Maintenance frequencies are set at 'annual' for all equipment regardless of criticality, usage rate, or manufacturer recommendations -- a heat sealer used 8 hours daily and a label printer used once weekly have the same maintenance interval (Minor NC)
• Maintenance schedule shows a significant proportion of preventive maintenance activities are overdue -- critical sealing and sterilization equipment are among the overdue items (Minor NC)
• Maintenance work orders state 'perform PM per schedule' with no specific activities, acceptance criteria, or parts replacement requirements -- the maintenance content is undefined (Minor NC)
• Manufacturer recommends quarterly maintenance for the filling machine but the organization performs it annually with no documented risk assessment justifying the deviation from manufacturer recommendations (Minor NC)

Review the maintenance schedule for 5 pieces of critical equipment. For 3 of these, pull the last 12 months of maintenance records and verify work was performed on schedule with documented activities and acceptance criteria.

• How do you determine whether maintenance on a specific piece of equipment can affect product quality?
• What happens when a preventive maintenance activity is overdue -- what is the escalation process?
• Show me an example where a maintenance failure led to a product quality issue -- how was it investigated?

• Maintenance records management system -- verify records are organized, retrievable by equipment, and maintained per 4.2.5 (controlled, protected, retained for defined periods)
• Complete maintenance history for sampled equipment -- verify records include date, technician, activities performed, findings, parts replaced, acceptance criteria verification, and return-to-service authorization
• Corrective maintenance (breakdown) records -- verify unscheduled repairs are documented with root cause, repair activities, impact assessment on product quality, and return-to-service verification
• Parts replacement records -- verify replaced parts are traceable (part number, lot number, supplier) especially for components that could affect product quality
• Out-of-specification findings during maintenance -- verify any abnormal findings during PM are investigated for potential impact on product manufactured since the last successful maintenance

• Maintenance records consist of a date stamp on the maintenance schedule with no detail about what work was performed, what was found, or who did the work -- the record does not demonstrate that maintenance was actually performed as required (Minor NC)
• Breakdown repair on a critical heat sealer was performed by an outside contractor but no record exists in the organization's maintenance system -- the repair was performed but not documented (Minor NC)
• Maintenance records for the last 6 months cannot be located -- the technician who maintained the records left the organization and the records were not transferred to the controlled record system (Minor NC)
• An out-of-specification finding during preventive maintenance (sealing temperature 5 degrees above specification) was corrected but no impact assessment was performed on product sealed since the last PM when the seal temperature was within specification (Major NC)
• Electronic maintenance records have no backup -- a server failure resulted in loss of months of maintenance history (Minor NC)

Pull complete maintenance histories for 2 critical equipment items covering the last 12 months. Verify record completeness (date, technician, activities, findings, acceptance criteria). Check 1 breakdown repair for impact assessment.

• Show me the most recent breakdown repair record for a critical piece of equipment -- was an impact assessment performed on product?
• How do you verify that maintenance was performed correctly when it is done by an outside contractor?
• What is the record retention period for maintenance records, and how was it determined?

• Facility layout drawings showing material flow, personnel flow, and product segregation -- verify the layout prevents cross-contamination between product types, between clean and non-clean areas, and between raw materials and finished goods
• Facility qualification records -- for controlled environments, verify IQ/OQ records documenting that the facility meets design specifications for temperature, humidity, particulate control, air changes, and differential pressure
• Utility specifications and qualification -- verify compressed air quality (ISO 8573), purified water quality (USP/EP specifications if applicable), HVAC capacity (air changes per hour, HEPA filtration), and electrical supply stability
• Workspace adequacy assessment -- verify sufficient space for operations without crowding that could increase error rates or contamination risk
• Utility monitoring records -- verify continuous or periodic monitoring of critical utilities with documented alert and action limits

• Production facility layout allows raw materials and finished goods to share the same corridor and staging area -- no physical segregation exists to prevent mix-ups or cross-contamination between incoming and outgoing product (Minor NC)
• HVAC system serving the cleanroom assembly area has not been requalified after a compressor replacement -- the original qualification was based on the previous compressor's airflow characteristics (Minor NC)
• Compressed air used in a pneumatic assembly process has no quality specification or monitoring -- particulate and moisture content is unknown and could affect product cleanliness (Minor NC)
• Workspace assessment reveals operators working in a packaging area with less than 3 feet of clearance between workstations, increasing risk of product mix-up between adjacent orders (Observation)
• Facility drawings on file do not reflect a recent renovation that changed material flow patterns -- the actual layout no longer matches the qualified layout (Minor NC)

Walk the complete production flow during the facility tour. Verify facility layout matches drawings. Check qualification records for 2 critical areas (cleanroom, incoming inspection). Verify utility specifications and monitoring for compressed air and HVAC.

• How was the facility layout designed to prevent cross-contamination -- was a formal risk assessment performed?
• What is the requalification schedule for your cleanroom HVAC system, and when was the last requalification?
• Show me the compressed air quality specification and the most recent monitoring results.

• Equipment inventory with criticality classification -- verify all process equipment is listed with identification number, location, criticality rating, qualification status, calibration due date, and maintenance schedule
• Equipment qualification records (IQ/OQ/PQ) -- for critical equipment, verify qualification protocols and reports demonstrate the equipment meets specifications and performs consistently within defined parameters
• Calibration records and status -- verify measurement equipment is calibrated on schedule, calibration certificates reference traceable standards, and out-of-tolerance conditions trigger impact assessments on previously measured product
• Software validation records -- verify software used in production, testing, or quality functions (LIMS, ERP production modules, statistical analysis, automated inspection) is validated per documented protocols
• Software change control records -- verify software updates and patches are controlled, validated before deployment, and documented

• Statistical process control (SPC) software used to make accept/reject decisions on production lots has no validation documentation -- the software was installed by the vendor and placed into production use without any validation activities (Major NC)
• A significant proportion of sampled measurement equipment has overdue calibrations -- a tensile tester has been months past its calibration due date while continuing to test production product (Major NC)
• Equipment qualification for a heat sealer was performed years ago with no periodic requalification despite the equipment being relocated, repaired, and used for a new product not included in the original qualification scope (Minor NC)
• ERP system controls batch numbering and lot traceability but is classified as 'business tool not requiring validation' -- the rationale for excluding a system that directly affects traceability is not documented (Minor NC)
• Equipment inventory lists hardware only -- production-supporting software (labeling systems, SPC tools, automated testing software) is not inventoried or tracked for validation status (Minor NC)

Select 3 critical production equipment items and verify IQ/OQ/PQ, calibration, and maintenance records. Select 2 software systems and verify validation records. During the facility tour, spot-check calibration stickers on 5 measurement instruments.

• What is your policy on software validation -- how do you determine which software requires validation?
• Show me the requalification schedule for critical equipment -- what triggers requalification?
• How do you handle an out-of-tolerance calibration finding -- show me the most recent impact assessment.

• IT infrastructure documentation -- verify servers, networks, databases, and cloud services supporting QMS and production operations are documented, maintained, and backed up with tested recovery procedures
• Disaster recovery and business continuity plan -- verify the plan covers loss of IT systems, communication systems, and transportation services with defined recovery time objectives and tested procedures
• Backup verification records -- verify backups of critical data (QMS records, production data, design files, training records) are tested periodically by performing actual data restoration, not just verifying backup job completion
• Communication system adequacy -- verify internal communication systems (email, phone, intercom, radio) are adequate for operational needs including emergency communication
• Transportation and logistics arrangements -- verify temperature-controlled shipping, cold chain management, and transportation providers are qualified where product integrity depends on transportation conditions

• No disaster recovery plan exists for the electronic QMS -- if the server fails, all electronic quality records, training records, and CAPA data would be lost; the last backup test was never performed (Major NC)
• IT backups are performed nightly but no backup restoration test has ever been performed -- the organization assumes backups are usable but has never verified this (Minor NC)
• Temperature-controlled shipping is required for 2 product families but the transportation provider is not qualified and no temperature monitoring data is collected during transit (Minor NC)
• Internal communication system relies on a single email server with no redundancy -- during a recent 3-day outage, quality notifications, CAPA communications, and nonconformance reports were delayed (Minor NC)

Review IT disaster recovery plan and the most recent backup restoration test record. Verify 1 transportation provider qualification for temperature-sensitive products. Check communication system redundancy for safety-critical notifications.

• When was the last time you performed a full data restoration from backup, and what was the result?
• How is cybersecurity managed for systems that affect product quality (production control, testing, labeling)?
• Show me the qualification records for your cold chain logistics provider.

• Environmental specifications by production area -- verify each area where environment affects product quality has defined requirements for temperature, humidity, particulate levels, lighting, and any other relevant parameters
• Environmental monitoring data and trend reports -- verify monitoring data shows consistent compliance with specifications over time; look for trends approaching limits that could indicate control degradation
• Environmental excursion records -- verify any out-of-specification conditions were detected, documented, investigated, and resolved with product impact assessment
• Risk assessment linking environment to product requirements -- verify the organization has assessed which environmental factors could affect each product type and established controls accordingly
• Facility tour observations -- during the walkthrough, use portable instruments or check fixed monitors to spot-verify environmental conditions against documented specifications

• Environmental specifications exist for the cleanroom but not for the general assembly area, incoming inspection area, or warehouse -- despite these areas having temperature-sensitive products and humidity-sensitive packaging operations (Minor NC)
• Environmental monitoring data for the cleanroom shows 3 excursions in the last 6 months where temperature exceeded the upper limit for 2-4 hours each time -- excursions were logged but no product impact assessment was performed for product manufactured during those periods (Major NC)
• Environmental monitoring is performed at a single fixed time each day but production runs for significantly longer hours -- conditions during the majority of production hours are unmonitored (Minor NC)
• Risk assessment for environmental factors was performed only for the cleanroom -- general production areas where non-sterile devices are assembled have no documented assessment of which environmental factors could affect product quality (Minor NC)

Review environmental specifications for 3 production areas. Check 6 months of monitoring data for the most critical area. Verify 2 environmental excursion records for proper investigation and product impact assessment.

• How was the environmental specification for this production area determined -- what product requirements drove it?
• Show me the most recent environmental excursion and the impact assessment on product manufactured during the excursion.
• What continuous monitoring is in place for critical environmental parameters?

• Environmental specification documents by area -- verify each controlled area has a specification sheet listing all controlled parameters with numerical limits
• Justification for specification limits -- verify limits are traceable to product requirements, process validation parameters, regulatory standards (ISO 14644 for cleanrooms, ISO 11607 for packaging), or manufacturer equipment requirements
• Completeness of parameters -- verify all relevant parameters are addressed, not just temperature and humidity; consider lighting (for visual inspection areas), static discharge (for ESD-sensitive devices), vibration (for precision assembly), and noise (for testing areas)
• Seasonal and shift variation consideration -- verify specifications account for environmental variation across seasons and shifts, not just steady-state conditions

• Environmental specifications define temperature and humidity but not lighting levels for the visual inspection area -- inspectors perform critical defect detection under unspecified and variable lighting conditions (Minor NC)
• Cleanroom classification is specified (ISO Class 7) but the specification does not include differential pressure requirements between the cleanroom and adjacent non-classified space -- the contamination barrier may not be maintained (Minor NC)
• Specification limits for humidity are set at 30-70% RH based on general comfort criteria rather than product-specific requirements -- adhesive bonding processes used in device assembly are sensitive to humidity above 55% RH (Minor NC)
• No environmental specification exists for the warehouse where finished devices are stored -- temperature extremes in the uncontrolled warehouse could affect product integrity of temperature-sensitive devices (Minor NC)

Review environmental specifications for 3 areas (cleanroom, general assembly, visual inspection). Verify completeness of parameters and justification for limits. Check that specifications consider all relevant parameters including lighting and static control.

• How were the environmental specification limits for this area determined -- what technical justification exists?
• What environmental specifications apply to the incoming inspection area and the finished goods warehouse?
• How do specifications account for seasonal variation -- is the HVAC system capable of maintaining requirements during peak summer and winter conditions?

• Environmental monitoring procedures -- verify they define monitoring parameters, sampling locations (with maps), frequencies, instruments, methods, and acceptance criteria for each controlled area
• Monitoring records for the last 3 months -- verify records are complete (no gaps in scheduled monitoring), within specification, and include date, time, location, reading, operator, and instrument identification
• Monitoring instrument calibration records -- verify all monitoring instruments (thermometers, hygrometers, particle counters, differential pressure gauges) are calibrated on schedule with traceable standards
• Continuous monitoring system validation -- for automated monitoring systems, verify the system has been validated, alarms are functional, and alarm thresholds match documented specifications
• Monitoring data trend analysis -- verify monitoring data is analyzed for trends, not just checked against limits; look for gradual drift toward limits that could indicate control degradation

• Monitoring records show 8 gaps in the last 3 months where no monitoring data was recorded on scheduled monitoring dates -- the organization has no explanation for the missing data and no evidence that conditions were verified on those days (Minor NC)
• Particle counter used for cleanroom classification monitoring has an overdue calibration of 2 months -- monitoring data from this instrument during the overdue period may not be reliable (Minor NC)
• Continuous monitoring system sends email alerts when limits are exceeded but no one checked email over a holiday weekend -- an excursion persisted for an extended period before detection (Minor NC)
• Monitoring is performed only during first shift but production continues through additional shifts -- the majority of daily production hours are unmonitored (Minor NC)
• Monitoring data is recorded on loose paper forms that are not controlled documents -- forms show multiple handwriting styles and some entries appear to be retrospectively added (Minor NC)

Review monitoring procedures for the most critical area. Check 3 months of monitoring records for completeness. Verify calibration status of 3 monitoring instruments. During the facility tour, compare live readings to documented specifications.

• How do you ensure environmental monitoring is performed during all production shifts, including weekends?
• What is the backup procedure when the continuous monitoring system fails?
• Show me the most recent trend analysis of environmental monitoring data -- are any parameters trending toward limits?

• Environmental control procedures -- verify documented methods for maintaining conditions within specifications including HVAC operation, filter management, pressure cascade maintenance, and seasonal adjustment protocols
• Excursion response procedure -- verify a documented procedure defines actions when conditions exceed limits: immediate correction, product segregation, impact assessment, root cause investigation, and return-to-normal verification
• Excursion records -- review actual excursion events for the last 12 months; verify each was handled per the documented procedure with complete documentation
• Product impact assessment from excursions -- verify any product manufactured, tested, or stored during an excursion was assessed for conformity and disposition decisions were documented
• Root cause investigation for recurring excursions -- verify repeated excursions in the same area trigger root cause investigation and corrective action, not just repeated correction

• Environmental excursion response consists of calling the HVAC technician with no documented procedure for product segregation or impact assessment during the period between detection and correction (Minor NC)
• Cleanroom temperature exceeded the upper limit for 4 hours during a HVAC compressor failure -- product assembled during this period was released without any assessment of whether the temperature excursion affected product quality (Major NC)
• Same environmental excursion (humidity spike) has occurred 5 times in 12 months in the same production area -- each time the immediate condition was corrected but no root cause investigation was performed to prevent recurrence (Minor NC)
• Environmental control procedures reference the HVAC operation manual but no specific procedure exists for cleanroom pressure cascade management -- how positive pressure is maintained between classified and non-classified spaces is not documented (Minor NC)

Review 3 environmental excursion records from the last 12 months. For each, verify detection, correction, product impact assessment, and root cause investigation. Check for recurring excursions indicating inadequate control.

• What is the maximum acceptable duration for an environmental excursion before product must be quarantined?
• Show me the root cause investigation for the most recurring environmental excursion.
• How do you determine whether product manufactured during an excursion is acceptable for release?

• Documented environmental requirements -- verify specific parameters (temperature, humidity, particulate count, differential pressure) with defined acceptance limits (alert and action levels) for each controlled area
• Monitoring procedures -- verify documented methods defining what to monitor, where to monitor (sampling locations), when to monitor (frequency), how to monitor (instruments, methods), and who performs monitoring
• Control procedures -- verify documented methods for maintaining environmental conditions within requirements, including HVAC operation, filter replacement, pressure cascade management, and deviation response
• Deviation response procedures -- verify documented actions when environmental conditions exceed limits, including immediate correction, product segregation, impact assessment, and root cause investigation
• Monitoring instrument specifications -- verify monitoring instruments are specified, calibrated, and appropriate for the parameters being measured (accuracy, resolution, range)

• Environmental requirements state 'controlled temperature and humidity' without defining specific limits -- operators have no numerical criteria to determine whether conditions are acceptable (Minor NC)
• Monitoring procedure exists but does not define sampling locations -- temperature is measured at one location in a 2000 sq ft cleanroom with known thermal gradients across the space (Minor NC)
• No deviation response procedure exists -- when monitoring shows an out-of-specification condition, the action is to call the facilities manager with no documented procedure for product segregation or impact assessment (Minor NC)
• Alert limits and action limits are not distinguished -- every excursion triggers the same response regardless of severity, leading to alarm fatigue and delayed responses to significant excursions (Observation)

Review documented requirements for 2 controlled areas. Review monitoring and control procedures for the most critical area. Verify alert/action limits are defined and that deviation response procedures include product impact assessment.

• Show me the specific acceptance limits for temperature and humidity in this production area -- what are the alert and action levels?
• If a monitoring reading exceeds the action limit at 2:00 AM on a weekend, what is the documented response?
• How were the monitoring locations and frequencies determined -- was a mapping study performed?

• Personnel health, hygiene, and clothing requirements document -- verify documented requirements for each controlled area defining health conditions requiring reporting, hygiene practices, and required garments/PPE with specifications
• Gowning procedure -- verify a step-by-step gowning procedure with sequence, technique requirements, and visual standards; verify gowning training includes practical assessment not just reading the procedure
• Health reporting and screening procedures -- verify requirements for reporting illness, skin conditions, or injuries that could contaminate product; check how reported conditions are managed (temporary reassignment, restricted access)
• Access control mechanisms -- verify controlled areas have access restrictions (badge access, sign-in logs, airlock procedures) preventing unauthorized or unqualified entry
• Gowning qualification records -- verify personnel who work in controlled areas have documented gowning qualification including practical assessment of technique

• Gowning procedure exists but gowning qualification is based only on reading the procedure and signing acknowledgment -- no practical assessment of gowning technique is performed (Minor NC)
• Health reporting requirement states employees should report illness but does not specify which conditions require reporting, how to report them, or what happens to work assignments when illness is reported -- the requirement is too vague to be effective (Minor NC)
• During the facility tour, an employee in the cleanroom assembly area was observed wearing a watch and ring under their gowning -- the gowning procedure prohibits jewelry but compliance is not monitored (Minor NC)
• No access control exists for the cleanroom -- any employee can enter without verification of gowning qualification or health status (Minor NC)
• Visitors and contractors enter controlled production areas with only a lab coat and no head covering, shoe covers, or health screening -- the requirement applies to 'all personnel' but is enforced only for regular employees (Minor NC)

Review gowning procedure and 3 personnel gowning qualification records. During facility tour, observe 2 gowning events and compare to procedure. Check visitor log for controlled area access and verify gowning compliance.

• How often is gowning technique reassessed after initial qualification?
• What happens when an employee reports illness that could affect the controlled area -- show me a recent example.
• How are visitor and contractor gowning and health requirements enforced?

• Health requirements -- verify documented conditions requiring reporting (respiratory illness, skin conditions, open wounds, gastrointestinal illness), exclusion criteria, return-to-work requirements, and health screening process for visitors
• Cleanliness requirements -- verify documented hand hygiene procedures, personal hygiene standards, prohibited items (cosmetics, perfumes, jewelry), and verification methods (hand washing verification, air shower requirements)
• Clothing specifications -- verify garment types (coveralls, hoods, masks, shoe covers, gloves) are specified by area classification, garment material and grade are defined (e.g., low-particulate non-shedding fabric), change frequency is documented, and laundering/sterilization requirements are specified
• Compliance verification records -- verify periodic observation audits of personnel practices and garment condition

• Health requirements state 'report illness to supervisor' but do not define which illnesses require reporting, when exclusion from the controlled area is required, or what medical clearance is needed for return to work -- the requirement is not specific enough to be consistently applied (Minor NC)
• No garment specification exists -- 'cleanroom gowns' are required but the material, classification, filtration efficiency, change frequency, and laundering process are not defined (Minor NC)
• Hand hygiene procedure requires hand washing before entering the cleanroom but no hand hygiene verification (UV fluorescent lotion test, ATP swab monitoring) is performed to confirm technique adequacy (Observation)
• Cleanroom garments are reusable but the maximum number of laundry cycles before garment retirement is not defined -- worn garments with degraded filtration continue in use (Minor NC)

Review health, cleanliness, and clothing requirements for the most critical controlled area. Verify garment specifications and laundering records. Check 3 personnel files for health screening records. During tour, observe hand hygiene and gowning practices.

• What is the specification for cleanroom garments including material, classification, and change frequency?
• How do you verify that hand hygiene technique is adequate -- what validation has been performed?
• What criteria trigger garment retirement, and how are worn garments identified?

• Temporary personnel management procedure -- verify documented requirements for competency assessment or supervision of temporary workers in controlled environments
• Escort and supervision records -- verify non-qualified personnel entering controlled areas are escorted by a competent person with documented sign-in/sign-out records
• Temporary worker competency records -- verify agency temps and contractors who work independently in controlled areas have been assessed and documented as competent in environmental requirements (gowning, hygiene, contamination prevention)
• Visitor access log for controlled areas -- verify all visitors are logged, escorted, and provided with appropriate garments before entering controlled production areas
• Maintenance technician qualification -- verify external maintenance technicians who enter controlled areas for equipment service are trained on environmental requirements before entry

• Temporary agency workers begin working on the cleanroom production line on their first day with only a 30-minute orientation -- no competency assessment for gowning technique, contamination prevention, or environmental requirements is performed before independent work (Major NC)
• HVAC maintenance technician enters the cleanroom without gowning to repair the air handling unit -- no procedure exists for managing maintenance access to controlled areas that maintains environmental integrity during the repair (Minor NC)
• Visitor escort procedure requires continuous accompaniment in controlled areas but visitors are regularly left unescorted after initial entry -- the procedure exists but is not followed (Minor NC)
• Auditors and regulatory inspectors are provided lab coats for controlled area access but not full gowning -- the contamination control requirements should apply equally to all personnel regardless of their role (Observation)

Review the temporary personnel management procedure. Check escort logs for the last month. Verify competency records for 2 temporary workers in controlled areas. Check maintenance access records for 1 equipment service event.

• How do you determine whether a temporary worker needs competency assessment versus supervision in a controlled area?
• What environmental controls are maintained during equipment maintenance in the cleanroom?
• Show me the competency assessment record for a temporary worker currently assigned to the cleanroom production line.

• Contamination control plan -- verify a comprehensive document defines contamination risks, control measures, monitoring requirements, and acceptance criteria for each product type and production area
• Cleanroom classification and requalification records -- verify cleanrooms are classified per ISO 14644-1 with at-rest and in-operation qualification data, and requalification is performed at defined intervals
• Microbial monitoring program -- verify settle plates, air sampling, surface sampling, and personnel monitoring are performed at defined frequencies with alert and action limits
• Particulate monitoring program -- verify particle counts are performed per ISO 14644-1 with results within classification limits
• Contamination control validation -- verify the contamination control process is validated to demonstrate consistent achievement of required cleanliness levels under production conditions

• Cleanroom was classified at installation but no requalification has been performed despite ISO 14644-2 requiring requalification at defined intervals (annually for particle count, semi-annually for air velocity, and as-needed for filter leak testing) (Major NC)
• Microbial monitoring program uses settle plates only with no active air sampling or surface sampling -- settle plates alone may not detect elevated bioburden levels in a timely manner (Minor NC)
• Environmental monitoring alert and action limits are not defined -- monitoring data is collected but there are no criteria for when to investigate or take corrective action until specification limits are exceeded (Minor NC)
• No contamination risk assessment exists specific to the products assembled in the controlled area -- contamination controls are based on general cleanroom standards rather than product-specific risk analysis (Minor NC)
• Trend analysis of microbial monitoring data over 12 months shows a gradual upward trend in average colony-forming units -- the trend was not identified because only individual results were compared to limits, not trended over time (Minor NC)

Review the contamination control plan and cleanroom classification records. Review 6 months of microbial and particulate monitoring data. Check for trend analysis. Verify 2 exceedance investigations.

• When was the cleanroom last reclassified per ISO 14644-1, and was it done both at-rest and in-operation?
• Show me the microbial trend data for the last 12 months -- are you seeing any upward trends?
• How do you manage contamination risk during the transfer of product from the cleanroom to the packaging area?

• Process agent inventory -- verify a complete list of all chemicals, cleaning agents, lubricants, mold release agents, flux, adhesives, and other materials that contact the product during manufacturing, with CAS numbers and safety data sheets
• Residual limits for each agent -- verify limits are established based on biocompatibility assessment (ISO 10993-17 for chemical characterization), toxicological evaluation, or published safety standards, with documented justification
• Removal or reduction procedures -- verify documented methods for removing or reducing each process agent to below the specified residual limit, including process parameters (time, temperature, concentration, rinse cycles)
• Removal process validation -- verify the removal process has been validated to consistently achieve residual levels below the specified limits under worst-case conditions
• Routine residual testing records -- verify ongoing verification that residual levels remain within specification after routine cleaning/removal processes

• Isopropyl alcohol used for final cleaning and silicone spray used as a mold release agent are not included in the process agent inventory -- the organization did not systematically identify all chemicals contacting the product (Minor NC)
• Residual limits for cleaning agents are based on supplier SDS 'safe for contact' statements rather than formal biocompatibility or toxicological assessment per ISO 10993-17 (Minor NC)
• Removal process for cutting fluid involves a single ultrasonic cleaning cycle, but no validation demonstrates this achieves residual levels below the specified limit -- the process was established by trial and error without formal validation (Minor NC)
• No routine residual testing is performed -- removal process validation was performed years ago but ongoing monitoring does not confirm the process continues to achieve required residual levels as cleaning solution ages, equipment wears, and production volumes change (Minor NC)
• Process agent substitution occurred (new cleaning solvent replaced the validated solvent) but the removal process was not revalidated for the new agent's chemistry (Major NC)

Walk the production line and independently identify all process agents. Compare against the documented inventory. Select 2 high-risk agents and verify residual limits (with justification), removal validation, and routine monitoring data.

• How do you identify when a new process agent is introduced -- what is the change control process?
• Show me the biocompatibility justification for the residual limit of your primary cleaning agent.
• When was the removal process for your highest-risk process agent last validated, and has anything changed since validation?

• Product cleanliness specifications -- verify documented cleanliness levels expressed in measurable terms (particulate limits per ISO 19227, bioburden limits, residual chemical limits) for each applicable product category
• Cleaning process validation records -- verify cleaning processes are validated to consistently achieve required cleanliness levels, including worst-case challenge testing
• Routine cleanliness verification data -- verify ongoing monitoring confirms cleaning processes continue to produce acceptable results (e.g., TOC testing, bioburden testing, particulate testing on cleaned product)
• Process agent identification and residual limits -- verify all process agents (cutting fluids, cleaning solvents, mold release agents, lubricants) are identified with maximum allowable residual levels based on biocompatibility assessment
• Customer documentation for products requiring customer cleaning -- verify IFU or cleaning instructions are validated and provided to customers when the customer is expected to clean the product before use

• Product cleanliness specification states 'visually clean' without measurable acceptance criteria -- visual inspection alone cannot detect sub-visible particulate or chemical residues that could affect patient safety (Minor NC for low-risk devices, Major NC for implantables)
• Cleaning validation was performed on a single product representative but 3 new product geometries have been added since validation -- the new geometries have recesses and blind holes not represented in the validation worst case (Minor NC)
• No routine cleanliness verification is performed after cleaning validation -- the organization assumes the validated cleaning process continues to perform without ongoing monitoring (Minor NC)
• A process agent (silicone mold release spray) is used in production but is not identified in the process agent inventory and no residual limit has been established (Minor NC)
• Products are supplied non-sterile with cleaning instructions in the IFU, but the cleaning instructions have never been validated to demonstrate they achieve the claimed cleanliness level when performed by the customer (Minor NC)

Identify which of the 4 scenarios apply. For each applicable scenario, review cleanliness specifications, cleaning validation records, and routine verification data. Verify the process agent inventory is complete by comparing against actual production chemical usage.

• What measurable cleanliness acceptance criteria apply to your products -- particulate limits, bioburden limits, chemical residue limits?
• Show me the list of all process agents that contact the product during manufacturing and their allowable residual limits.
• How do you verify that customer-facing cleaning instructions in the IFU are effective?