SharkNinja® Supplier
Audit Interactive Guide

As an accredited Conformity Assessment Body through the ANSI National Accreditation Board (ANAB), UL Solutions provides independent, accredited third-party manufacturing and process assessments against defined standards. Our Supplier Quality Audits and Certifications program helps minimize supply chain risk, protect brand value, and promote consumer and product safety. Use this Audit Guide to evaluate your readiness for a Supplier Quality Audit.

Section 1: Management responsibility

Success all starts with management

Section 2: Continuous Improvement

Management must provide resources to implement systems for continuous improvement

Section 3: Quality system

The quality management system must define the key elements that control processes and ensure UL and SharkNinja requirements are met

Section 4: Purchasing

Effective supply chain management is a critical control process

Section 5: Process control

Defining and implementing effective process controls will improve process consistency and improve product quality

Section 6: Inspection & test

Robust in-process and final inspection/test processes contribute to improved compliance with safety and quality requirements

Section 7: Inspection Measuring & Test Equipment & preventive maintenance

Effective calibration and preventive maintenance programs provide confidence in the accuracy and consistency of compliance measurements

Section 8: Control of nonconforming product

Effective controls for handling potential defects will reduce chances of non-conformances being shipped to customer

Section 9: Corrective action & risk avoidance

Effective corrective and preventive actions reduce the likelihood of recurrence and contribute to a culture of continuous improvement

Section 10: Document control

Effective document control systems include both internal and external documents corrective and ensure current requirements are available and used

Section 11: Handling, storage, packaging, & delivery

Raw materials, in-process materials, and finished products must be identified, packaged, and protected to minimize damage throughout the factory

Section 12: Restricted substances

RRS controls must be implemented throughout the QMS. This means RRS is documented in vendor specs, checked at incoming, included in production documents, verified annually, and documents are updated any time components or materials change.

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  1. Supplier implements CAPA report for nonconformance / abnormal cases and critical defects.
  2. The CAPA report should include but is not limited to Non-Conformance Description, Root Cause Analysis, Corrective Action, Preventive Action.
  3. The CAPA report should be recorded and updated as progress is made.
  4. Data from CAPAs should be analyzed. And top (typical) defects for CAPAs should be communicated with employees either by training, daily meeting or posting information in public area.
  1. Corrective Action and Preventive Action procedure, QP-QC-009, Rev. 03, dated 2024 07 30.
  2. Corrective Action and Preventive Action report, form No. QC-DC-0001, Rev. 2, dated 2023 04 05, case# 20240101 was reviewed.
  3. Training record for case# 20240101 was reviewed.
  4. All the top/typical defects are posted in a public area and communicated to employees during daily meeting.
  5. Meeting minutes from 2024 Mar 01 were reviewed.
  1. Supplier should assign a person/department who is responsible for product complying with all requirements from customer and 3rd party regulatory.
  2. This person/department shall be familiar with those noted requirements as well. This is to ensure that those requirements are integrated into all departments.
  3. All requirements from customer and 3rd party regulatory should be incorporated within but not limited to the followings:
    i. Bill Of Materials (BOM)
    ii. Specification Documents.
    iii. Quality Control Plan (IQC, IPQC, OQF, FQC, …).
    iv. SOPs.
    v. Test Instructions.
    vi. Product Labeling, etc.
  4. Internal Audits: Supplier incorporates all requirements from customer and 3rd party regulatory into Internal Audit.
  1. BOM for model DZ300, Rev. 01, dated 2023 05 22 was reviewed.
  2. Quality Control Plan, QC-FT-001, Rev. 03, dated 2024 02 02 was reviewed.
  3. SOPs for IQC, IPQC, OQF, FQC were reviewed.
  4. Records for SOPs for IQC, IPQC, OQF, FQC were reviewed.
  5. Internal audit report in 2024 was reviewed, all findings were solved with 8D reports and supporting evidence.
  1. An individual or department should be assigned to be responsible for RRS compliance at the factory.
  2. RRS requirements should be clearly defined. Specific plans and activities should be established to ensure the RRS requirements are met.
  1. Mr. James is assigned to be a management representative, who is responsible for RRS in factory.
  2. RRS Training plan in 2024 was reviewed.
  3. Training records according to RRS Training plan in 2024 were reviewed.
  4. Activities related to RRS are defined in document “Controlling RRS procedure, FT-QD-008, Rev. 01, dated 2023 05 06”. Records were available as well.
  1. Supplier should define training program at company (basic training, regular training, re-training, special operation skill … and including RRS).
  2. A specific training plan should be established.
  3. Training materials should be available.
  4. Training records should be maintained and should include (but not limited to): Training Date, Trainee, Trainer, Document for Training (Training Material), Signature …
  5. Validating training effectiveness, if needed.
  1. Human Resource and Training, FT-QD-11, Rev. 9, dated 2024 05 09.
  2. Training Plan in 2024 was available. RRS was also included in the Training Plan in 2024.
  3. Training records according to Training Plan in 2024 were available.

Section 2: Senior management is responsible for establishing a mindset and culture of “Continuous Improvement”. This requirement applies to manufacturing processes, inspection and testing, final quality checks, as well as supporting processes including customer complaints, purchasing, supplier performance monitoring, product safety issues (such as UL Variation Notices), customer complaints, and other metrics that influence safety and quality. Common best practices include, but are not limited, to the following:

  • Key Performance Indicators (KPI) Metrics boards posted visibly in production and support areas that include quality, delivery, and productivity/efficiency measures that apply to that area.
  • Daily "Gemba" walks by management (including production, quality, maintenance/engineering, purchasing/materials control, etc.) to walk through the production area. Review KPIs, production processes, identify potential issues and take containment actions where appropriate.
  1. Reviewed the Quality Metrics Dashboard which is updated monthly.
  2. Examined Process improvement meeting minutes from 2024 06 15.
  3. Reviewed records of quarterly management reviews for Q2 and Q3 discussing KPIs.
  1. Senior management needs to establish specific metrics related to productivity and efficiency, then measure them and post results.
  2. At a high level, senior management needs to review these productivity measures over the quarter, or year, or Year over year (YoY) comparisons. Where there are problems or decreases, senior management must implement Corrective Actions or “Continuous Improvement” initiatives to improve performance. Records of these evaluations and actions taken must be kept.
  3. Supply chain control is a key part of Product Safety and Quality metrics performance. This means senior management must establish a program for evaluating supplier performance that includes specific metrics for Quality, compliance to Restricted and Regulated Substances (RRS) requirements, as well as on-time delivery. Records of these metrics, periodic evaluation of them, and resulting actions taken must be kept.
  1. Reviewed Resource allocation report, dated 2024 05 01, showing budgeted tools.
  2. Saw 2024 Training schedule for continuous improvement tools (e.g., Six Sigma).
  3. Reviewed employee feedback surveys on resource availability from Q2.

Senior management must establish metrics for On-Time Delivery (OTD) and keep records. There must be a documented process for notifying customers in advance if a shipment will be late for any reason. Records of the notifications must be kept.

  1. Reviewed On-Time Delivery (OTD) report for Q2 2024.
  2. Reviewed Supplier performance evaluation report, dated 2024 07 01.
  3. Reviewed two Corrective Action Reports taken for OTD issues, recorded in CAPA form and notification to clients.
  1. Senior management must establish a process for handling customer complaints. Customer complaints may include:
    a. Damaged products
    b. Products that do not perform or function as intended
    c. Late shipments
    d. Warranty claims
    e. Or other issues that result in customer dissatisfaction
  2. Some companies claim they have no, or very few complaints. This is difficult to believe since most companies receive customer feedback through multiple channels (e.g. product didn’t work as expected, product packaging was poor, shipment was late, etc.). It doesn’t have to be a formal “Customer Complaint” to be considered a point of customer dissatisfaction. These customer dissatisfaction situations should be incorporated into the Customer Complaint resolution process.
  3. In cases where root cause cannot be attributed to the supplier, or is unknown (e.g. product damaged in transit), the supplier must document investigation and any actions taken to address the customer concern.
  4. In cases where the defect is the fault of the supplier, the supplier must create a CAR that documents root cause(s), containment actions, and corrective actions taken to prevent recurrence.
  5. At a macro level, senior management must analyze customer complaint trends over time. Reviews must be documented, and any high level actions taken to reduce customer dissatisfaction (e.g. design changes, shipment fulfillment process changes, supplier lead time changes, etc.), must be recorded.
  1. Reviewed Customer complaint log, dated 2024 06 30.
  2. Saw Root cause analysis report for complaint #C20240101.
  3. Reviewed Customer satisfaction survey results from Q1 2024.

Section 3 requires Senior Management to devote the appropriate resources to develop and implement an effective quality management system. This section requires:

  1. Use of Control Plans that address critical characteristics.
  2. Establishing an effective system for identification and control of Restricted and Regulated Substances (RRS).
  3. Having an effective process for controlling documents including prints and specs, SOPs, external documents (like customer drawings, or external standards e.g., UL).
  4. Establishing an effective Engineering Change Request (ECR) and Engineering Change Notice (ECN) process for any product or component changes.
    a. This ECR/ECN process includes both customer generated changes, as well as supplier initiated changes.
    b. Evidence of customer approval PRIOR to the change implementation must be maintained.
  5. Senior management must devote adequate resources to developing and implementing an effective Training System for production, quality, and support personnel who have an impact on product safety and quality.
  6. A system of records keeping must be established including identifying what specific records will be kept, duration of their retention, method or location for storage, and disposition of records.
  1. Quality Control Plan, document QCP-2024-001, Rev. 2.
  2. Process control audit report, dated 2024 05 20.
  3. Corrective actions for process deviations, CAPA #20240102.
  1. An effective process must be established for controlling documents. This includes, but is not limited to the following types of documents:
    a. Prints and specs
    b. SOPs, Work Instructions, Job Aids, and other instructional documents
    c. External documents (like customer drawings and specifications) and external specifications and standards (e.g., UL, Good Manufacturing Practices, etc.)
  2. This also means establishing an effective Engineering Change Request (ECR) and Engineering Change Notice (ECN) process for any product or component changes.
    a. This ECR/ECN process includes both customer generated changes, as well as supplier initiated changes
    b. Evidence of customer approval PRIOR to the change implementation must be maintained
  1. Document Control SOP, DOC-CTRL-2024-01, Rev. 1.
  2. List of controlled documents with last revision dates.
  3. Internal audit report on document control, dated 2024 04 15.

The supplier’s training program must include Corrective Action training and Continuous Improvement training. This should include the functions and departments likely to be involved in the investigation, containment, and corrective action implementation activities OR Continous Improvement activities.

  1. Employee training records for Quality System, dated 2024 03 10.
  2. Attendance sheet from quality awareness workshop, QW-2024-01.
  3. Employee feedback survey on Quality System training effectiveness.
  1. The Supplier must establish an SOP for controlling records.
    a. Best practices: SOP defines identification of records, i.e. what specific records must be kept
    b. The record storage method should be defined (electronic copy, hard copy, location, etc.)
    c. The record duration/retention times, archiving & disposition, etc., must be defined too
    d. Best practice is to keep a master list of records to be maintained
    e. An alternate approach: each SOP, Work Instruction, or job aid defines specific records to be maintained (including storage, retention, archive, etc.)
  1. Controlled Quality Records index, last updated 2024 05 01.
  2. Example of completed inspection record, document IR-2024-123.
  3. Internal audit findings related to quality record control, dated 2024 06 15.
  1. Establish an SOP for supplier’s qualification program which shall included at least,
    i. Frequency for qualification (initial and surveillance)
    ii. Item to be evaluated (quality, delivery, intregrity etc.)
    iii. Level of result (score, level A B C, %) and action to be taken.
  2. Performed qualification per SOP with record as evidence.
  3. Be sure to include qualification criteria for suppliers of Restricted and Regulated Substances (RRS).
  1. Supplier Qualification SOP, document SQP-2024-01, Rev. 2.
  2. Approved Vendor List (AVL) with qualification dates.
  3. Supplier audit report, dated 2024 04 30, for new supplier qualification.
  1. Purchased materials must have a spec/drawing available (either defined by SN, the supplier, or if it’s a catalog item … then the sub-contractor has a catalog/specification).
  2. Purchase orders or contracts must reference the specification/drawing number/part number and revision level.
    a. These purchasing documents should include Restricted and Regulated Substances (RRS) requirements.
  3. An incoming inspection process must be effectively implemented to ensure no defects are allowed into the system.
  1. Material Specification Document for part #ABC123, Rev. 5, dated 2024 03 01.
  2. Purchase Order #PO20240430 with defined material specs.
  3. Incoming material inspection report, dated 2024 05 10.
  1. An Approved Vendor List (AVL) is available, which includes the supplier name, business type, contact person information (name, email, telephone number), address, date of joining, delivery term, payment term, etc.
  2. The AVL should also include the part category(s) or part numbers for which each supplier is approved.
  1. Approved Vendor List (AVL) updated as of 2024 06 01.
  2. Vendor re-qualification audit report for vendor XYZ, dated 2024 05 15.
  3. Meeting minutes from supplier review meeting, dated 2024 05 20.
  1. PO’s with vendors must include RRS requirements.
  2. Alternative: Specification/drawing shall include this RRS requirement and this specification referenced on the Purchase Order.
  3. The purchase order should including the revision level of the specification or drawing.
  1. Purchase Order #PO20240501 including RRS clause, dated 2024 05 01.
  2. Supplier contract with 2nd tier supplier, including RRS compliance requirements.
  3. Supplier audit report ensuring RRS compliance, dated 2024 06 10.
  1. Tag identified for incoming material must have proper traceability information (i.e.: part number, quantity, lot number, date of received, date of production, status of inspection etc.).
  2. SOP for inventory management of First In First Out (FIFO) shall be set up, to specify how to manage FIFO, for example: identify by color sticker, segregate by zone/area etc., or use Inventory Management System to identify age/picking locations.
  1. Inspection report for incoming parts, including label verification, dated 2024 05 15.
  2. Labeling SOP, document LAB-SOP-2024-01, Rev. 3.
  3. Internal audit report on labeling process, dated 2024 06 05.
  1. SOP for ECN/ECR shall be established to control the change requested.
    a. This includes changes made from customer or
    b. Changes initiated by the supplier
    c. Both processes shall include final approval from customer.
  2. SOP shall include awareness of RRS requirement when issuing ECN.
  3. ECN/ECR form is recommended to include verification of RRS item (can be N/A if not applicable).
  1. Engineering Change Notice (ECN) log, last updated 2024 07 01.
  2. Example of an approved ECN, document ECN-2024-05.
  3. Meeting minutes from ECN review meeting, dated 2024 06 20.
  1. The process control method focuses on managing and optimizing the various factors within the manufacturing process to ensure consistent quality and desired outcomes. The supplier may design the control system with considering:
    a. The process goals and variables to be controlled.
    b. Select suitable sensors to measure the variables and design a feedback loop with controllers to make decisions.
    c. Choosing the appropriate actuators to impact the changes in the process.
    d. Developing control algorithms and logic to regulate the system.
    e. Implementing safety measures and alarms.
    f. Testing the system in real-world conditions.
    g. Adjusting the control parameters based on performance feedback and ensuring the system maintains desired outcomes efficiently and safely.

Examples – the Work Instructions for specified workstations/steps; the fixture and jigs; mechanical counters; electronic sensors, job sheet; bar coding with software integration and control; marking; training; visual checks; automation.

  1. For Production Line#1, Production Process control Plan(LS&HM-HD430-001 A01) applied and used by production operators.
  2. For Production Line#1, Quality Control Plan(CP-HD430(US)-001-A00) used by IPQC inspectors.
  1. The supplier shall clearly indicate the specifications and tolerance the process needs to meet.
  2. The supplier should consider: task (identifies the activities), frequency, standard/requirements, specifications, tools/materials.
  3. The 1st piece inspection shall be performed and cover the performance/safety testing which are required by the supplier/TIC organization.

For production line#1 (SN model# HD430):

  1. Daily preproduction checklist.
  2. First piece check record dated 2024-05-08.
  3. Daily Setup and operating parameters of the tools and equipment verified.
  1. There should be a written procedure on the equipment and instrument management.
  2. The equipment and instrument shall be validated before the production.
  3. The 1st piece product should be verified as being in compliance with all the required specifications (e.g., construction, performance).

For production line#1 (Model# HD430):

  1. Equipment and tooling management control procedure(QHM-QP-S4-001A02).
  2. Daily check records reviewed.
  1. The operators shall have the training records and know their authority when there is defective products identified.
    a. Note: The auditor may conduct interviews with operators to verify they have this authority.

For Production Line#1:

  1. One operator (ID: BL3628) responsible for Hi-Pot Testing was verified and expected to initiate line stoppage when defective material is identified.
  2. Related personnel training record (dated on 20240410) reviewed and found acceptable.

The production record should contain the product traceability information (e.g., Lot #, date, production Line #, operator, etc.).

  1. Product identification and traceability control procedure(LS&HM-QESP-050A02).
  2. Production Process Control Procedure(LS&HMQESP-020 A04).

The product shall bear the information (e.g., SN, date, or code) to trace back to the production record (e.g., components used, test performed, inspection record, etc).

  1. “Product Identification and Traceability Control” procedure(LS&HM-QESP-050A02) reviewed.
  2. Examined products (Model SC4890) in Final Inspection area and confirmed product markings, date code, and serial number aligned with SOP requirements and enabled trace back to production records.

In case of non-compliant products, the supplier should have a process to identify and isolate the non-compliant product. There should be a way to distinguish the non-compliant product from the compliant products.

The non-compliant product should be disposed properly. Only the product meeting all the requirements can bear the UL Mark.

  1. Control of nonconforming product procedure(LS&HMQESP-014 A05).
  2. Daily repairing record was checked (For Production Line#1, date 20240508).

There should be a qualification process (e.g., training, qualification) for the operator. The Wis should be accessible to the operators. The WIs should be controlled to ensure the updated version is used.

In Production Line#1:

  1. Production Process control Plan (LS&HM-HD430-001 A01) applied and used by production operators.
  2. All required Work Instructions and Work Standards are available for operators reference at each workstation.
  1. The supplier shall have an effective process for inspecting incoming materials.
  2. SOPs or Work Instructions for Incoming Quality Control (ICQ) should have clearly defined responsible persons and make reference to the specifications of the incoming materials.
  3. The material (or component) shall be identified for status and identification before and after IQC.
  4. Best practice is to establish a designated inspection spec sheet for each incoming material, with defined acceptance/rejection criteria.
  5. The retention period and storage method for Incoming inspection records shall be defined and followed.
  6. Once incoming materials and components have been inspected, they are accepted, rejected, or sorted according to their conformity with the required standards.
  1. Reviewed HD400 IQC Work Instructions (LS&HM-QESF-12-124A02) to ensure process is followed.
  2. Reviewed four Incoming Inspection Records:
    i. PO-2024-03-0764_Motor_2024.04.21
    ii. PO-2024-03-0314_2024.04.19
    iii. PO-2024-03-0428_2024.04.03
    iv. PO-2024-03-0862_PSC assembly_ELE_2024.04.23)
  1. The supplier shall have clear in-process instruction instructions that include the components covered, the testing items required, and the acceptance criteria.
  2. The inspection records shall be kept for a defined time period.
  1. Reviewed In-Process Inspection Instruction WIPQC-L3-300 v2 to ensure process is followed.
  2. IPQC record dated 2024.05.08 was checked and found OK (Line#1, Model: HD430, Po#20109441).
The supplier must document test procedures for production line testing. The procedures must include:
  1. Sampling: what number of samples to be tested? or 100% tested?
  2. If sampling, then samples are taken from production line according to the sampling plan.
  3. Testing is conducted using approved methods and acceptable equipment within valid calibration status.
  4. Best practice is to perform functional check each shift or each day with known “good” samples, and known “Fail” samples, to ensure test equipment is functioning as intended. And keep records!
  5. Results of production line tests are recorded and records maintained.
  6. Best practice is to analyze results over time for trends.
  1. CTQ testing map was checked (doc# LS&HM-HD430-001 A01).
  2. CTQ Testing instructions – Hi-Pot testing values are set at 1500Vac, 5mA, 1S (Line#1, model# HD430) which complies with minimum UL safety requirement values for hi-pot testing.
  1. During the in-process inspection process, qualified personnel thoroughly document their findings, recording measurements, detecting defects or deviations, and conducting a comprehensive evaluation of the product’s quality.
  2. These may result in an inspection report, serving as a valuable record of the product’s conformity to defined standards.
  3. Based on the inspection results, appropriate actions may be taken: products meeting established standards are approved for further processing and distribution, while minor defects undergo rework or repair to meet quality requirements.
  4. Conversely, if significant issues arise or products fail to meet standards, the entire batch may be rejected, and corrective measures are implemented to prevent similar problems in future production runs.
  1. IPQC record dated 2024.05.08 was checked (Line#1, Model: HD430, PO # 20109441).
  2. Product online defect record was reviewed (2024.03).
  3. All NC & CARs were effectively closed.
  1. The supplier shall assure no product be shipped out until all FQC processes have been satisfactorily completed, and all the associated results are acceptable and documented.
  2. Best practice: Implement bar code scanners to ensure each required production, inspection, and test activity is performed, and that Production Planning System (e.g., MRP or ERP system) won’t allow product to ship until all required inspections and tests have been successfully completed.
  1. Reviewed HD400 Finished-Product Inspection SIP (HMQESF-12-088-F01-A07) to ensure it is followed.
  2. Reviewed Final Quality Check (FQC) records:
    i. Dated 2024.04.16 (Line#3, model# HD430, PO# 240416) &
    ii. 2024.05.08 (Line #1, Model : HD430, Po#240508)
  1. The Supplier must have a documented procedure defining the calibration process, and the SOP must address all the requirements defined in the “Common Records” section.
  2. The calibration system must include all Inspection, Measuring, and Test Equipment (IMTE) used to verify compliance with requirements.
  3. Planning for calibration: Ensure all IMTE is calibrated before the next due date.
    i. This means there must be a recall method in place to notify each area when equipment is coming due for calibration.
    ii.. Each area should plan for back-up equipment while IMTE is out for calibration.
    iii. Alternatively, calibration can be performed during production down-time.
    iv. While not required, some companies benefit from using a calibration system software tool to manage their inventory and calibration schedules for IMTE.
  4.  The Supplier should have a Master List of IMTE and Calibration Plan to ensure the calibration can be monitored.
  5. Out of Tolerance (OOT) Condition: If calibration results are “Fail” or “Out of Tolerance” (OOT), the supplier must evaluate the OOT condition, consider how the IMTE is used, and compare it to the tolerance of the product measurement or test parameter.
    i. Could the OOT condition resulted in wrong test results (based on the tolerances of the measurement required)?
    ii. Could there be product shipped that is non-conforming as a result?
    iii. This OOT evaluation should be documented.
    iv. Worse case, if needed, recall of product initiated to confirm it complies with requirements.
  1. Reviewed Master List of IMTE, MT-QD-002, Rev. 4, dated 2024 02 02.
  2. Reviewed Calibration Plan in 2024, MT-QD-002-PL, Rev. 1, dated 2024 06 02.
  3. The following pieces of equipment were verified, calibration records were available, appropriate calibration label was available on each equipment.
    i. Electronic Scale in warehouse, serial # ZRTH98002, calibration cert. no. 9QP0002221.
    ii. Caliper in IQC, serial # GHK72, calibration cert. no. 222333OOP01.
    iii. Hipot Tester in Production Line#1, serial # BHJ999II, calibration cert. no. 83894945AA.
  1. The supplier needs to select the right kind of Inspection Measuring and Test Equipment (IMTE) based on the product measurement to be made (e.g., dimension, test value, etc.).
  2. IMTE must be capable of precision required for the measurement.
    i. For example, if measurement requires +/- 0.01 precision, then IMTE must be able to measure +/- 0.001 (one decimal place more)
    ii. As an extreme example, you would NOT use a tape measure with fractions for a measurement that requires precision of one or more decimal points (e.g., measurement tolerance = +/- 0.20 mm).
  3. All IMTE used are to be kept in good working condition with a current calibration status.
  4. Operators should be trained and must be able to demonstrate proper use of IMTE, including examples of when product fails.
  1. Reviewed multiple pieces of measuring equipment for proper calibration.
    i. Electronic Scale in warehouse, serial # ZRTH98002
    ii. Caliper in IQC, serial # GHK72
    iii. Hipot Tester in Production Line#1, serial # BHJ999
    iv. AII were found in good working condition and equipment are capable of precision required for the measurement.
  2. Interviewed Mr. Jack, ID 0009 in Production Line#1 & Ms. Daisy, 0293 in IQC & Mr. Ken, ID 2223 in warehouse. They are knowledgeable about use of IMTE.
  1. The Supplier should have a documented SOP that defines the preventive maintenance (PM) program.
  2. Supplier should have a master list of equipment that requires Preventive Maintenance.
  3. The PM plan should define frequency and steps (e.g., daily, weekly, monthly, quarterly, and yearly required PM actions).
  4. The PM SOP should provide instructions on how to perform PM for each equipment, or to define PM Technician capabilities needed to perform PM (e.g., certified electrician, etc.).
  5. Records of PM must be maintained.
  6. Best Practice: Consider implementing a “Predictive Maintenance” system that adjusts PM frequency based on prior PM results.
  7. Best Practice: Fixtures used to hold product in place while going through production or test processes should be included in PM program to periodically check for wear, distortion, damage, adjustment, etc.
  1. Reviewed Preventive Maintenance procedure, MN-QD-003, Rev. 03, dated 2023 04 05 to ensure requirements are followed.
  2. Reviewed Preventive Maintenance Plan for 2024, MN-QD-003-PL, Rev. 09, dated 2024 04 07.
  3. Reviewed SOPs for Preventive Maintenance for each equipment was available.
  4. Preventive Maintenance records were reviewed for 2024 01 05 & 2024 05 08 & 2024 07 01 and found to be in compliance with SOP.
  1. This element applies to Incoming Quality Control (IQC) / Incoming Inspection. It could also apply to purchased products that are found in production areas.
  2. Purchased products, components or materials that are found to be non-conforming must be identified to prevent further use.
  3. Where possible, these materials should be moved out of the normal process flow (unless it’s impractical to do so).
    i. This could include use of red “NC” bins or NC shelves in IQC or production areas
    ii. This could include use of a tag or other physical label attached to the product that clearly shows it is Non-Conforming or suspect.
  4. Records of these non-conforming products must be kept.
    i. The process for taking the NC records and recording them in a database should be described in the NC Materials SOP or area specific SOP.
    ii. Records should be available of periodic analysis of NC products by management along with actions to be taken to reduce/control incidence rate.
  1. Reviewed Incoming Quality Control area, and “Incoming Quality Control” Procedure IQC-Inspection-S002 version 3 which describes handling of non-conforming product.
  2. All non-conformances are isolated in the “Non-conformance Area” with a “Red Tag” applied on those products with non-conformances.
  3. Reviewed three examples of NC product in IQC Area and found to be in compliance with SOP.
    i. Nonconformance report for “Front Housing” was reviewed. Report CAR# 01011224.
  4. Verified that these non-conformances are recorded and analyzed according to CAPA procedure.
  1. This element applies to control of non-conforming product in Production Areas and Final Inspection.
  2. Any suspect and/or non-conforming product must be identified.
    i. This could include use of red “NC” bins or shelves in production areas.
    ii. The MC product should be physically labeled with an ID, tag, label, or some method so individuals will know the status as Non-Conforming.
  3. These non-conforming materials should be segregated, unless there is no means to do so (e.g. automated conveyor line).
  4. Records of these non-conforming products must be kept.
    i. The process for taking the NC records and recording them in a database should be described in the NC Materials SOP or area specific SOP.
    ii. Records should be available of periodic analysis of NC products by management along with actions to be taken to reduce/control incidence rate.
  1. Reviewed SOP for handling NC product in product ion area, “Control of Non-Conforming Product” NC-MFG-S004, version 5.
  2. Reviewed Non-conformance area in Assembly Cell and checked seven examples of NC products.
    i. All non-conformances are properly isolated in “Nonconformance Area” and labeled with “Red Tag” in accordance with SOP.
    ii. Nonconformance report for “Front Housing” was reviewed. Report CAR# 01011224.
    iii. The nonconformance are recorded and analyzed according to CAPA procedure.
  1. This element describes a Material Review Board or similar function that is responsible for reviewing and dispositioning defective, non-conforming, or suspect product.
  2. There should be an SOP that defines the roles and responsibilities of those with defined authority for making this disposition.
    i. The frequency, method, and related records for these reviews should be defined in the SOP.
  3. For a disposition involving re-work: any non-conforming product that is re-worked to bring it back into compliance must be re-inspected and/or re-tested (if required) before returning to production process.
  1. Reviewed “Controlling Nonconformance procedure”, QC-QD-010, Rev. 05, dated 2024 07 01.
  2. This SOP defines Material Review Board “MRB” roles, and frequency of meetings for disposition of NC product.
    i. Sampled 3 red-tag records for proper MRB disposition and sign-off. Complied with SOP.
  3. Reviewed “Re-Work procedure”, QC-QD-011, Rev. 02, dated 2024 02 03.
    i. Verified Nonconformance report for “Impeller” on 2024 03 02, report # 11202403.
    ii. Verified Re-work record, form QC-FR-003, Rev. 05, dated 2024 01 01 and product was re-inspected before being returned to Assembly Cell.
  1. This element defines the need for using identification tags, labels, forms, and other suitable methods to identify suspect or Non-conforming product.
  2. The Supplier must have a defined SOP for dealing with NC products.
    i. This SOP should define the methods for how to identify NC product with use of tags, forms, reports, quarantine areas, etc.
    ii. This SOP should also define control methods to ensure that re-worked NC product is re-inspected and / or re-tested before it is returned to production areas.
    iii. The SOP should also describe how records of NC products are compiled and analyzed by management for trends and actions to be taken to reduce NC incidence rate.
  1. Reviewed “Controlling Nonconforming Product” procedure, QC-QD-010, Rev. 05, dated 2024 07 01.
  2. SOP describes use of red tags to identify non-conforming product and need to quarantine NC Product to “Non-Conformance” shelf.
  3. SOP describes Material Review Board roles and responsibilities.
  4. Reviewed “Re-Work” procedure, QC-QD-011, Rev. 02, dated 2024 02 03.
  5. Reviewed Non-Conformance Report for “Impeller” on 2024 03 02, report # 11202403 and found to comply with SOP.
  6. Reviewed Re-work record, form QC-FR-003, Rev. 05, dated 2024 01 01 and found to comply with SOP.
  1. Formal Corrective Action System: The supplier should establish a comprehensive corrective action system that assigns responsibility, tracks progress, and ensures the closure of corrective actions. This system should be aligned with industry standards such as ISO 9001 or similar.
  2. Root Cause Analysis: The corrective action process should begin with a thorough root cause analysis to identify the underlying issues. Tools like the 5 Whys, Fishbone Diagram, or Failure Mode and Effects Analysis (FMEA) can be used.
  3. Monitoring and Follow-Up: The system should include regular monitoring and follow-up to verify the effectiveness of the corrective actions taken. This should be documented, and any recurring issues should trigger a re-evaluation of the corrective measures.
  4. Integration with Continuous Improvement: Corrective Actions should not just address immediate problems but also feed into a Continuous Improvement program, ensuring that lessons learned are applied across the organization.
  1. Corrective Action Request (CAR) log, last updated 2024 05 30.
  2. Example of completed CAR, document CAR-2024-03.
  3. Corrective action tracking spreadsheet, showing status of all open CARs.
  1. Preventive Action Implementation: The supplier should establish a procedure to implement preventive measures that proactively address potential issues identified during risk assessments, audits, or customer feedback.
  2. Effectiveness Verification: This procedure should include steps to verify the effectiveness of the preventive measures after implementation, ensuring that they prevent the recurrence of potential problems.
  3. Documentation: All preventive measures and their effectiveness should be documented, with records maintained to demonstrate continuous improvement and compliance with quality standards.
  1. Preventive Action Plan for potential issue XYZ, dated 2024 05 15.
  2. Verification report for preventive actions, document PAP-2024-02, dated 2024 06 10.
  3. Meeting minutes discussing the effectiveness of preventive measures, dated 2024 06 20.
  1. Supplier should establish a procedure for ensuring that all permanent changes resulting from corrective or preventive actions are consistently updated in all relevant documentation.
  2. This process should include change control protocols and regular audits to verify that changes are fully implemented across all affected documents and systems.
  1. Updated SOP reflecting changes from CAPA, document SOP-2024-06, Rev. 3.
  2. Meeting minutes from change control board discussing CAPA updates, dated 2024 06 25.
  3. Audit report confirming that changes have been implemented across all relevant documents, dated 2024 07 01.

The supplier maintains a well-documented procedure for managing controlled documents, as outlined in the Document Control Procedure. Key elements include:

  • Identification: All controlled documents are identified with part numbers, revision levels, and effective dates.
  • Obsolete Document Removal: Defines "obsolete" documents and outlines their identification, marking, access restriction, and physical removal.
  • Access Control: Implements password protection for the electronic master list, with periodic reviews to ensure only authorized personnel can edit or delete documents.

Additional Considerations:

  1. Document Control Procedure: Should cover maintaining a master list, including the identification and removal of obsolete documents, and access control.
  2. Document Types: Consider all types of documents, including:
    – Quality Assurance Manual
    – Standard Operating Procedures (SOPs)
    – Work Instructions, Job Aids, Control Plans
    – Specifications, standards, reference documents
    – Forms, data sheets, inspection and production tally sheets
  3. Formats: Documents may be in hard copy or electronic format; the SOP and Master List should account for both.
  4. External Documents: Must be controlled to ensure current versions are used, including customer specifications, UL standards, and other regulatory documents. Their distribution should be controlled, and a process for updating obsolete versions must be in place.
  5. Records Management: Completed forms and data sheets become “Records” subject to the Records Control SOP.
  • Reviewed document control procedure, doc# HNM-010; Rev 1.0; Issued date: 02.01.2024.
  • Reviewed master list, doc#MTL-001; Rev 01; Issued date: 02.01.2024 - Verified completeness and accuracy of document listings with part numbers, revision levels, and effective dates.
  • Interviewed QMS Manager (Employee#xxx) regarding obsolete document removal (demonstrated understanding of the documented process for identifying and removing obsolete documents, including marking and restricting access).
  • Verified password protection for electronic master list and documented access permission review procedures.

The supplier demonstrates robust control over issuing and revising manufacturing, process, and configuration documents, as outlined in the Document Control Procedure. Key elements include:

  • Approval Process: A defined approval process for new and revised documents ensures proper review and authorization by designated personnel.
  • Distribution: A controlled distribution list ensures all relevant personnel receive the latest revisions of documents.
  • Version Control:** Implemented through a revision history system, allowing personnel to easily identify and use the latest.
  • Obsolete Document Prevention: Measures include preventing the use of obsolete documents on the shop floor, either by physical removal or clear marking. (Observed during shop floor walkthrough).

Additional Considerations:

  1. Control Requirements:
    – Defined approval process for documents.
    – Method for distributing documents, such as a controlled distribution list.
    – Version control system to ensure only the latest revisions are used.
    – Process for identifying and preventing the use of obsolete documents.
  2. Best Practice Examples:
    – Handling changes to shop orders on the production floor.
    – Updating and communicating changes to production personnel.
    – Ensuring shop orders have revision control that matches MRP/ERP system requirements.
  • Document Control Procedure (doc# HNM-010; Rev 1.0; Issued date: 02.01.2024).
  • Reviewed SOP#WI-001; Rev 2; Issued date: 02.01.2024; SOP#WH-001; Rev 1; Issued date: 02.01.2024; SOP#FQCWI-001; Rev1; Issued date: 02.01.2024 for details on issuing and revising documents.
  • Observed the document distribution process (confirmed consistent adherence to the documented controlled distribution list) for these SOP#WI-001; Rev 2; Issued date: 02.01.2024; SOP#WH-001; Rev 1; Issued date: 02.01.2024; SOP#FQCWI-001; Rev1; Issued date: 02.01.2024.
  • Verified version control methods through document revision history. Interviewed shop floor personnel (Production operator, employee#HNM-0022; Warehouse keeper; employee#HNM-0240; FQC staff, employee#HNM-0110) regarding document usage (all personnel confirmed using the latest revisions).
  • Observed the shop floor environment and noted the absence of any obsolete documents in use.

The supplier provides comprehensive training on document control procedures, which includes:

  • Importance: Training on the importance of document control in maintaining quality standards.
  • Employee Role: Emphasizing roles in identifying and reporting document-related issues and encouraging active participation in maintaining document accuracy through established channels.
  • Corrective Action Process: Including employee involvement in identifying document control issues, with documented examples available for review.
  • Continuous Improvement (CI): Actively seeking opportunities for document updates or improvements through the CI process, with recent projects demonstrating employee participation.

Additional Points:

  1. Training should link the training process to the document control system.
  2. Employees should understand the document control system and its importance.
  3. Employees should understand their roles in corrective actions and continuous improvement (CI).
  • Reviewed training records for document control procedures dated on 22.05.2024 (demonstrated comprehensive and up-to-date training).
  • Interviewed employees (Production Manager, Employee#xxx; Technical Manager, Employee#xxx; Sale manager, Employee#xxx; regarding their understanding of document control procedures (identified strong understanding and willingness to participate in identifying and reporting document issues).
  • Reviewed corrective action records (CA#001-2024; CA#003-2024; CA#005-2024; identified documented examples of employee involvement in identifying document control issues).
  • Reviewed CI records (CI#001-2024; CI-002-2024; CI#006-2024; identified documented instances of document updates or improvements implemented as part of CI activities, suggesting employee participation).

The latest customer specifications were consistently included in the master list. During the shop floor observation, personnel were able to locate and access the most recent customer specifications. Printed copies were strategically placed near workstations and consistently updated. Additionally, a system for electronic access at workstations ensures immediate access to the latest versions.

Additional Points:

  1. Focus on controlling external documents like customer specifications.
  2. The Document Control SOP should define roles, responsibilities, and methods for handling customer specifications:
    – When first received
    – When revisions are updated
  3. The process should ensure specifications are readily available and used by manufacturing personnel.
  4. Control of external specifications may be linked to the Engineering Change Request/Engineering Change Notice process.
  • Reviewed document control procedure for handling customer specifications doc#HNM-012; Rev 01; Issued date: 02.01.2024 - Confirmed clear and effective communication..
  • Verified the latest drawing of 03 parts (1.SN-ABC01;2. SN-ABC02;SN-ABC-35) and confirmed the all requirement is included in BOM for model SN-ABC; Rev 02; Issued date: 05.02.2024.
  • Observed shop floor environment for customer specification accessibility (demonstrated readily available and up-to-date access). Interviewed shop floor personnel (Interviewed shop floor personnel (Production supervisor, employee#HNM-0020; Warehouse keeper; employee#HNM-0240; FQC staff, employee#HNM-0110) regarding their awareness and access to customer specifications (confirmed knowledge of location and ability to access latest versions through both printed and electronic systems).

Supplier Procedures for Handling Raw Materials
The supplier maintains well-documented procedures for handling raw materials, ensuring their proper protection and identification from receiving to point of use.

  1. Receiving and Inspection:
    – Inspects incoming raw materials against purchase orders and material specifications
    – Non-conforming materials are quarantined in designated areas with clear labels indicating their status
  2. Identification Methods:
    – Lot numbers are used to identify raw materials, displayed on containers and labels for traceability throughout production.
  3. Storage Practices:
    – Defined storage practices minimize the risk of damage or contamination
    – Adheres to a First-In, First-Out (FIFO) system to ensure material usage in the order received
  4. Reprocessed/Recycled Materials:
    – Specific procedures exist for handling reprocessed, recycled, reground, and scrap materials
    – These materials are clearly identified and segregated in designated storage areas, and reprocessing procedures ensure they meet quality standards before reintroduction into production

Additional Considerations:

  1. Scope: This element applies to raw materials in all areas where they are stored and processed.
  2. Requirements: The Supplier must have documented procedures ensuring protection and identification of raw materials, including:
    – Receiving and inspecting procedures
    – Methods for identifying raw material type and status (e.g., part number, lot numbers, work order numbers, quarantine areas for non-conforming materials)
    – Proper storage practices to prevent damage or contamination
    – Procedures for handling reprocessed, recycled, reground, or scrap materials
  3. Inventory Management: Proper inventory management practices, such as FIFO (First-In, First-Out), must be in place.
  1. Reviewed documented procedures for raw material handling (doc#HNM-011; Rev 01; Issued date: 02.01.2024).
  2. Observed the receiving and inspection process for raw materials (P/N: 123456, lot#123; 234567; lot#234; 345678, lot#345 & confirmed adherence to procedures).
  3. Verified identification methods throughout the process (P/N: 123456, lot#123; 234567; lot#234; 345678, lot#345; lot numbers &QC passed stamp on containers and labels).
  4. Examined storage areas for proper segregation and protection (FIFO system by color stamp to identified receiving date, verified these parts P/N: 123456, lot#123; 234567; lot#234; 345678, lot#345, separate areas for rework/scrap with red identified lines & board).
  5. Reviewed procedures and observed practices for handling reprocessed/recycled materials. Reviewed Scrapt report for P/N: 123456; Lot#010; P/:23456; Lot#012; P/N: 345678; Lot#009; dated on 05.07.2024.

Supplier System for Identifying and Storing WIP
The supplier has a well-defined system for identifying and storing Work In Process (WIP). 

  1. Scope: Applies to how products are handled, stored, and managed in production areas/WIP.
  2. Requirements: The supplier should have defined procedures for WIP that include:
    – Identification: Using part numbers and revision levels.
    – Labeling: Durable and legible labeling methods for WIP.
  3. Storage Practices: Appropriate storage practices should be in place to prevent damage or confusion, such as designated storage areas and separation by stage of production.

Reviewed WIP for below parts:

  • Enclosure with P/N: 1023987; Lot#05.07.2024; Mfr date: 05.07.2024; q'ty: 50 pcs. This part is molded in side the factory & ready for final assembly.
  • Motor with P/N: 1052908; Lot#05.07.2024; Mfr date: 05.07.2024; q'ty: 50 pcs. This part is assembled in line#2 & ready for final assembly.
  • Harness with P/N: 10600279; Lot#05.07.2024; Mfr date: 05.07.2024; q'ty: 50 pcs. This part is assembled in harness line #1 and ready for final assembly.

Supplier Practices for Safeguarding Finished Products
The supplier has implemented practices to safeguard finished products from damage during handling and storage.

  1. Documented Procedures: Documented procedures outline handling techniques to minimize mechanical shock, emphasizing appropriate lifting equipment and careful handling practices.
  2. Environmental Controls: Controls are implemented to prevent damage from temperature and humidity, with gauges and controls strategically placed in storage areas.
  3. Storage Practices: Finished products are stored in designated areas with adequate stacking practices to prevent damage from neighboring items.

Additional Considerations:

  1. Scope: Requires the supplier to establish practices to safeguard finished products from damage during handling and storage.
  2. Requirements: The supplier must have documented procedures that address:
    – Minimizing mechanical shock and potential damage.
    – Implementing environmental controls to prevent damage (e.g., temperature, humidity).
    – Ensuring proper storage practices to prevent in-plant damage (e.g., designated areas, adequate stacking).
  3. Special Storage or Handling Requirements: Identify products with special storage or handling needs, including:
    – Environmental controls such as temperature, humidity, and clean room conditions.
    – Shelf life items, with controls to remove expired products from use.
  4. ESD Controls: Implement appropriate Electro-Static Discharge (ESD) controls by evaluating products for potential ESD damage, including:
    – Use of wrist straps/heel straps in relevant areas.
    – Use of ESD dissipative packaging materials (e.g., sleeves, bags, foam, boxes).
    – Implementing checks for ESD protections (e.g., daily checks for wrist straps, heel straps, inclusion of ESD testers in calibration or PM programs).
    – ESD training for operators to understand the potential impact of ESD damage.
  1. Reviewed documented procedures for product handling and storage (SOP#HNM-WH-013; Rev 01; Issued date: 02.01.2024).
  2. Observed product handling practices on the shop floor (use of proper lifting techniques, use of protective equipment; Reviewed the height of 3 pallets and confirmed those are not higher than 2.2m against to product handling and storage SOP).
  3. Verified environmental controls are implemented and monitored (daily check sheet records for electronics warehouse in May, June & July 2024).
  4. Checked storage areas at position M1-10; L2-09; P3-02 in warehouse to confirm appropriate storage (e.g., designated areas, no risk of damage from stacking or neighboring items).

Supplier Compliance with Customer Packaging Specifications
The supplier ensures packaging meets customer specifications and includes all required markings.

  1. Documented Procedures: Procedures reference the latest customer specifications for packaging requirements and define the verification process.
  2. Verification Process: The packaging process includes a verification step to ensure compliance with customer specifications, either through inspections by personnel or automated systems.
  3. Product Labeling: Procedures ensure products are labeled with required information such as part numbers, lot codes, and handling instructions.

Additional Considerations:

  1. Scope: Applies to finished products, their identification, and packaging.
  2. Requirements: The Supplier must ensure compliance with customer specifications for packaging and required markings, including:
    –     Documented procedures referencing customer packaging requirements.
    –     A defined process for verifying that packaging meets specifications.
    –     Procedures for labeling products with required information (e.g., part numbers, lot codes, handling instructions).
    –     Country-specific/destination marking and labeling requirements based on the target geographical destination.
    – Ensuring product destined for specific markets (e.g., the US) includes all required safety markings, caution labels, product identification markings, and customer-specified labeling requirements.
  1. Reviewed documented procedures for product packaging and labeling Product Packaging and Labeling Work Instruction; doc#WI-PAK-001; Rev 01; Issued date: 02.01.2024).
  2. Verified the supplier has access to and references the latest customer specifications for packaging (dawing#SN-050; Rev 01; Issued date: 12.12.2023).
  3. Observed the packaging process to see if specifications are followed.
  4. Examined finished products (Model ABC; Lot#123456, P/O: 123456; Model ABC; Lot#123478; P/O: 123478; Model ABD; Lot#123489; Lot#123489) to confirm correct labeling and markings are present.
  1. The supplier must have an SOP for Restricted and Regulated Substances (RRS).
  2. The SOP shall define when to review RRS requirements
    i. This is especially important before purchasing materials / components (initial review) and who will be responsible for it.
    ii. This review must also occur whenever component or materials are revised, updated, replaced, etc.
  3. This review must in compliance with SharkNinja RRS’s requirement too.
  4. Scope covered all materials/ components used in products.
  5. Any changes/ updates must be re-reviewed
    i. Best Practice: this will not be missed if the Supplier has a good Engineering Change Request (ECR) / Engineering Change Notice (ECN) process in place that includes awareness of RRS).
    ii. Remember: If there is a new supplier, or a change in vendor, this RRS review must be performed.
  6. Records of RRS review must be kept and available.
  1. Restricted Materials Review SOP, document RMR-2024-01, Rev. 2.
  2. Review checklist for restricted materials, dated 2024 05 15.
  3. Approval records for restricted materials used in product XYZ, dated 2024 06 01.
  1. This element is requiring the Supplier to have an effective process for translating all of the SharkNinja RRS requirements into their management system.
  2. The RRS SOP shall be set up to include SharkNinja requirement for RRS.
  3. This RRS requirement shall be specified in specification/ drawing as well.
  4. These documents were in controlled manner and were accessible by related key personal.
  5. Best practice: It is very important for the supplier’s ECR / ECN process to consider the compliance impact to RRS requirements when there are changes to drawings and specifications.
  6. External auditors may interview employees in various areas to ensure they have current specs and understand RRS impact.
  1. Supplier RRS Compliance SOP, document RRS-2024-01, Rev. 3.
  2. Supplier training records on RRS requirements, dated 2024 05 10.
  3. Audit report ensuring compliance with RRS requirements, dated 2024 06 20.
  1. The Supplier must have an SOP defining Restricted and Regulated Substances (RRS) controls.
  2. The SOP shall be set up to specify how and when to conduct re-review of RRS for materials/ components after initial review (i.e., the Supplier must conduct re-review once per year).
  3. Records of RRS review must be kept and available.
  1. RRS Review Process SOP, document RRS-REV-2024-01, Rev. 2.
  2. Review checklist for RRS compliance, dated 2024 05 20.
  3. Minutes from RRS review meeting, dated 2024 06 10.
  1. This element applies to purchased components, sub-assemblies, and semi-finished products from vendors, and their vendors.
  2. The RRS SOP shall specify review and/or re-review of RRS compliance and must cover tier 2 (or 3) of materials/components too
    i. For example, a vendor PCB assembler who buys a lot of materials and components to assemble a Printed Circuit Board assembly
    ii. This vendor must provide a proper RRS certificate that includes materials, raw board, and inserted PCB components from tier 2 suppliers.
  3. Records of RRS review must be kept and available.
  1. RRS Testing Verification SOP, document RRS-TEST-2024-01, Rev. 1.
  2. Test verification report for product ABC, dated 2024 05 25.
  3. Meeting minutes discussing RRS test results, dated 2024 06 05.
  1. This element requires 3rd party independent testing for Restricted and Regulated Substances on critical components.
  2. The RRS SOP shall specify how many materials/components shall be sent for test at 3rd party lab.
  3. The minimum frequency for this testing is at least annually.
  4. Higher risk materials should be at a higher frequency.
    i. The external auditor may focus on high risk and/or critical materials/components when selecting samples to review for this requirement.
  5. Best Practice: The Supplier should create an annual RRS testing plan that specifies what materials/components shall be tested and when.
  6. Record of testing must be kept and available.
  7. This RRS Testing shall be done by a 3rd party lab that is accredited (e.g., accredited to ISO 17021, ISO 17025, etc.).
  1. 3rd Party Testing SOP, document 3PT-2024-01, Rev. 2.
  2. Testing report from external lab for component XYZ, dated 2024 06 15.
  3.  Records of testing frequency and results, maintained in testing log.