WI-H-003 Inspection and Acceptance Work Instruction

Rev A
Rev Description of Change Reason for Change Revision Author Effective Change
Date Number

A Initial Release To describe the process Vanesa Fields 0825/2015 CN-1016

and To meet
requirements per 21
CFR 820.80 and 21 CFR
820.86
 Inspection and Acceptance WI-H-003 Rev A
Work Instruction Effective Date:08/25/2015

1. Purpose

1.1. This procedure describes the process steps for inspecting and accepting materials and
products.

2. Scope
2.1. This document applies to personnel who involved in receiving inspection, in-process inspection,
final inspection and approvals for all levels of products, including raw materials, components,
and finished goods. This includes both in-house manufactured and vendor supplied items.
2.2. This procedure defines requirements to be followed by the Modal Manufacturing Supply Chain
for suppliers providing either a finished product where Modal Manufacturing is the legal
manufacturer or suppliers providing a component (including subassemblies, raw materials,
packaging and/or approved rework/refurbished products) used in a device or product whereby
Modal Manufacturing is the legal manufacturer.
2.3. This applies to off the shelf components.
2.4. This is applicable to components and/or finished devices that are intended to be for salable
release.
2.5. Exclusions
2.5.1.This does not apply to indirect material suppliers

3. Responsibilities
3.1. Quality Engineer- Review and Approve inspection reports/records
3.2. Manufacturing Engineer, PD Engineer- Assist in development of acceptance activities and
criteria as related to manufacturing
3.3. Product Development (Design) Personnel- Define and document the minimum requirements for
evaluating a device based on design specifications, feature form, fit, function; and product risk
assessment. These requirements must be met for vendor supplied items.
3.4. Customer Service/Receiving Personnel- Perform receipt Activities, Execute Receiving Inspection
Activities, Execute disposition of Materials (as required) and Nonconformance initiation for
components and/or finished devices being inspected at Receiving Inspection

4. References
4.1. SOP-H-001 Product Receipt and Inspection
4.2. SOP-H-003 Returned Product Control and Inspection
4.3. SOP-E-001 Supplier Evaluation
4.4. FM-E-001 Approved Supplier List
4.5. WI-H-001 Visual Defects Specification Femorals
4.6. WI-H-002 Visual Defects Specification Tibial Inserts
4.7. FM-H-001 Product Receipt and Returned Product Inspection Record
4.8. 21 CFR 820.80
4.9. 21 CFR 820.86
4.10. ISO 13485

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5. Definitions and Abbreviations

5.1. Acceptance Activities- inspections, tests, and verifications that are developed to determine if the
materials or products meet the specified requirements and ultimately the Device Master Record,
DMR.
5.2. Acceptance Criteria- the specific details and requirements within the inspections, tests, and
verifications, used for acceptance activities.
5.3. CoA- Certificate of Acceptance
5.4. CoC- Certificate of Conformity
5.5. DHR- Device History Record
5.6. Inspection Plan- a controlled document that describes how a quality inspection of a component
or finished device will occur. An inspection plan may contain information pertaining to the
specification, sequence of operations required, and test equipment.
5.7. IMTE- inspection, measuring and test equipment
5.8. Itemized Components- components that are countable and defined at a unit level
5.9. LHR- Lot History Record
5.10. Non-itemized (Bulk) Components- components that, due to their inherent nature, are not
countable and are instead defined and stored as a bulk lot of material. Examples include liquids,
powders, reels of film, reels of components, or threaded materials
5.11. RI – Receiving Inspection
5.12. Risk to Consumer- Risk to Consumer, or Consumer’ Risk, is the risk of accepting a lot
which should have been rejected
5.13. Risk to Producer- Risk to Producer, or Producer’s Risk, is the risk of rejecting a lot of
which should have been accepted. This risk is often referred to as Alpha risk or Type I Error
5.14. Sampling plan- A sampling plan establishes quantities of samples to be take and
frequency or timing for taking samples. A sampling plan is often contained in an inspection plan.
Sampling plans can contain elements such as characteristics to be measured and specifics on
how samples are to be taken, if these elements are not already contained in a corresponding
inspection plan
5.15. Standard Inspection Methodology- considered to be standardized if it is substantially
equivalent to another inspection method including the equipment, operator or inspector
involvement and level of training, fixturing, gauge R& R results, and/or any other significant
factors that go into the inspection technique. Details of the standardized inspection method may
be documented as required, based on the complexity of the inspection.
5.16. Mistake Proofing, Poke-Yoke- a mechanism or fixture to identify and prevent errors as
they occur. The operator or inspector is alerted of the error and it is prevented.

6. General
6.1. 21 CFR 820.80- (a) General. Each manufacturer shall establish and maintain procedures for
acceptance activities. Acceptance activities include inspections, tests, or other verification
activities.
6.2. 21 CFR 820.86- Each manufacturer shall identify by suitable means the acceptance status of
product, to indicate the conformance or nonconformance of product with acceptance criteria.
6.3. The entirety of the required acceptance criteria may be documented on multiple procedures,
forms, and documents. Examples of documents that may contain acceptance criteria include but

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are not limited to inspection sheets, process sheets, routers, work orders, engineering
specifications, etc.
6.4. The acceptance criteria must be documented and allow for the person performing the inspection,
test, or acceptance activity to do the following;
6.4.1.document the results of the acceptance activities,
6.4.2.signature of the person performing and the date when the acceptance activities were
performed,
6.4.3.document the equipment used for the acceptance activities,
6.5. All material and product must be controlled and not released to the next process step or
operation until the acceptance criteria at the current step has been either accepted and
approved or has been dispositioned accordingly per SOP-I-001 Nonconformance Controls.
6.6. cGXP Requirements: All Incoming Inspection activities will be conducted according to applicable
current good manufacturing practices (cGMP), current good tissue practices (cGTP), and current
good documentation practices (cGDP).
6.7. Environmental Health & Safety Requirements: All RI activities will be performed in compliance
with applicable health and safety requirements.
6.8. Inspection Results Recording: Component or finished device inspection and/or test results will
be recorded in the applicable document record and/or electronic system. Results will be
reviewed and compared against the requirements as outlined in the applicable specification.
6.9. Lot Disposition: The Receiving Inspection process will assure that the test results meet the
applicable inspection requirements.
6.9.1.Lot disposition for acceptance or rejection will be recorded in the document record and/or
electronic system.
6.9.2.Lots that do not conform to the applicable inspection requirements will be controlled and
dispositioned as per the defined Non-Conformance (NC) procedure.
6.10.

7. Procedures

7.1. Approved Supplier Control

7.1.1.Verify the components, finished devices or tissue products received were purchased from
approved suppliers- refer to FM-E-001 Approved Supplier List.
7.1.2.Do not accept into inventory any materials from unapproved suppliers per FM-E-001. These
materials will be placed on Quality Hold in a Quarantine area for review and disposition.

7.2. Receiving Inspection Set-up

7.2.1.Verify Line Clearance at work station
7.2.2.Verify calibration record is displayed on or near IMTE or verify the calibration is current via
salesforce library Calibration Records.
7.2.3.Log the ID of any IMTE used- record on Calibrated IMTE log
7.2.4.Inspector must have the following documents set up for inspection
 Calibration Log
 Product Inspection Sheet(s)
 Part drawing- as applicable

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 Product Visual specification(s)- as applicable

 Material Specification- as applicable
 Standard Operating Procedure or Work Instruction for inspection and
acceptance
 Receiving Inspection Report opened in topshelf
 Label specification(s)- as applicable for supplier received Modal product

7.3. Procedure for Inspection Activities

7.3.1.Receiving Process
7.3.1.1. Receive the shipment from the carrier.
7.3.1.2. Confirm the following:
7.3.1.3. Check shipping and supplier documents- packing slips, certifications, etc.
7.3.1.4. Verify the number of containers/items
7.3.1.5. Check containers or material for obvious damage or contamination. Obtain
concurrence of damage or contamination when applicable from truck driver.
7.3.1.6. Verify items listed on the packing slip are included in the shipment,
discrepancies will be noted by the receiver.
7.3.1.7. Record the PO number and part identification code of the product being received
into topshelf
7.3.1.8. Log the date received
7.3.1.9. Log the inspector
7.3.1.10. Move the received product into the proper bin in topshelf for product receipt
7.3.1.11. When product inspection is required, begin the set-up for the receiving inspection
process.
7.3.1.12. Place the product(s) in the “Inspection Queue” area.

7.3.2.Inspection Process for Incoming Product

7.3.2.1. Follow the inspection plan created for received product(s)- Product receipt
and inspection is documented on Form FM-H-001 - Product Receipt and Inspection
Record
7.3.2.2. Verify the following data/criteria on product received matches the packing slip
data:
 Product Name of the product
 Revision on package
 Lot number
 Lot size / Quantity
 Expiry date

7.3.2.3. Inspect the packaging for the following conditions:

7.3.2.3..1. Any visible damage to the outside of the packaging
7.3.2.3..2. Discoloration to packaging material
7.3.2.3..3. Dirty/Torn/Marked On
7.3.2.3..4. Cloudy

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7.3.2.3..5. Holes/Staples in the packaging

7.3.2.3..6. Tape or adhesive residue

7.3.2.4. Inspect the label and provide inspection comments for:

7.3.2.4..1. Yellow, Fading, Discoloration
7.3.2.4..2. Legibility and Clarity
7.3.2.4..3. Blurred or Distorted
7.3.2.4..4. Marred or Damaged
7.3.2.4..5. Label placement
7.3.2.4..6. Label content as specified in label specification sheet;
Information is incorrect or omitted

7.3.3.Inspection for Incoming RMA product

7.3.3.1. Verify the RMA number is on the outside of the package- record into the
inspection report
7.3.3.2. Verify the quantity matched the RMA sheet
7.3.3.3. Verify lot/identification numbers match the identifiers on the RMA sheet
7.3.3.4. Inspect the outside of the packaging for any visible damage

7.3.3.5. Inspect for any damage not reported on the RMA sheet- comment on the inspection
report.

7.4. Acceptance Activities

7.4.1.Acceptance of Product(s) and Documentation

7.4.1.1. The batch record (DHR/LHR/etc.) and/or certification documents (CoA, CoC, etc)
may be reviewed to confirm that the product was manufactured correctly, that the
certificates/ documents were generated correctly, and that they contain the right
information

7.4.2.Accepting Sampling

7.4.2.1. Modal Manufacturing will use Normal Severity of Level II settings for acceptance
sampling

7.4.2.2. Sampling plans for RI of itemized or unitized components or finished devices will
consider using the latest version of national or international standard procedures,
such as one of the following:

 ANSI/ASQ Z1.4 – Sampling Procedures and Tables for Inspection by Attributes

 ANSI /ASQ Z1.9 – Sampling Procedures and Tables for Inspection by Variables
for Percent Nonconforming

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 ISO2859 – Sampling procedures for inspection by attributes

 ISO3951 - Sampling procedures for inspection by variables

 ASQ - Zero Acceptance Number Sampling Plans (Nicholas L. Squeglia)

7.4.2.3. Harm Severity- determined in accordance with the table below:

Harm Risk Area Effects and Potential Impact Recommended

Severity Inspection Severity
AQL
Product Defect or latent inadequacies in the design lead to a
malfunction that may lead to, in the worst case, the
5 death of the patient or user.
Critical Processing Extremely serious defect which probably 100% Inspection
(Manufacture) compromises the safety of the patient and/or
adherence to legal regulations.
Product Defect or latent inadequacies in the design lead to
severely restricted function of the product. This can
4
lead to serious injury to the user and/or patient.
Major
Processing Great dissatisfaction of the customer / user due to AQL 1.0
(Manufacture) the defect error. Function seriously impaired.
Product Defect or latent inadequacies in the design lead to
restricted function of the product. This can lead to
3
slight injury to the user and/or patient. AQL 1.0
Moderate
Processing Moderate defect that leads to dissatisfaction with
(Manufacture) some customers/users.
Product Effect barely noticeable. Defect or latent
inadequacies in the design lead to annoyance of the
2 user, are not, however, severe enough to lead to an AQL 1.0
Marginal injury of the user or patient.
Processing The defect is insignificant and the customer / user
(Manufacture) are only slightly irritated.
Product No noticeable effect. Defect or latent inadequacies
in the design do not lead to injury of the user or
patient. Other
Processing It is unlikely that the defect has any noticeable effect
1 (Manufacture) on the product. Is not discovered by the customer /
Negligible user.
Documentation, It is unlikely that the defect has any noticeable effect 1 piece
Raw Material (bar on the product. Is not discovered by the customer /
stock), Destructive user.
samples

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7.4.2.4. Recommended Inspection Severity Acceptable Quality Level (AQL) (6) – List the
AQL associated with the defined Harm Severity. (See table above).
7.4.2.5. Any sampling scheme other than 100%, 1.0 AQL (ANSI/ASQ Z1.4 R2013), or 1
piece, shall be validated, in accordance with appropriate procedures, prior to use in
the Inspection Plan.
7.4.2.6. 1 piece shall be used for documentation reviews (COA, COC), raw material
(bar stock) and or samples that must be destroyed to ensure conformity.
7.4.2.7. Sampling Method Selected - Most common methods are Audit (random selection
of the samples across the entire lot) or 100% (all units in the lot must be inspected).
Other options are Statistical, Systemic, and Strategic.

8. IDENTIFICATION AND RETENTION OF QUALITY RECORDS

All Quality Records will be identified and retained in accordance with SOP-M-001 Records
Management.

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