STANDARD OPERATING PROCEDURE

Title: Master Sampling Plan Approvals (Signature and Date):

_____________________________ Responsible Department Head ____________________________ Technical Authority ____________________________ QA/QC

Effective Date: __________________

1.

PURPOSE 1.1 To provide a guideline for determining appropriate sampling plans used to assess the quality of product and production related materials.

2.

SCOPE 2.1 2.2 This procedure applies to final product and subassemblies manufactured for clinical and commercial uses. This procedure applies to parts purchased from outside vendors and used in manufacturing processes and final kit assemblies.

3.

RESPONSIBILITY 3.1 3.2 QA/QC management is responsible for assessing and determining sampling plans and methods for product and processes. Manufacturing, Development, and Engineering personnel are responsible for assisting in the development of product and process sampling plans and methods.

4.

REFERENCES AND APPLICABLE DOCUMENTS 4.1 4.2 4.3 4.4 4.5 4.6 ISO TR 8550 Guide For The Selection of An Acceptance Sampling System, Scheme, or Plan For the Inspection of Discrete Items In Lots ISO 2859-1 Sampling Procedures For Inspection By Attributes ISO 3534 Statistics - Vocabulary and Symbols ANSI/ASQC S2: Introduction to Attribute Sampling 09-0074-SOP-1.0, QC Sampling Plans & Techniques "An Easy Approach to Acceptance Sampling", Weber, Richard, ASQC Quality Press, 1991

5.

DOCUMENTATION REQUIREMENTS 5.1 Sampling plans for parts and materials are specified in PNS documents. The PNS will refer the reader to 09-0074-SOP-1.0, QC Sampling Plans & Techniques, for general methods and sampling plans. The PNS should identify the sampling plan, methods, and equipment that are specific ONLY to the part or material. QC personnel will record the results of the inspection activities on the QC Inspection Services Request and Lot Summary form attached to the PNS document. For in-process sampling, the sample amount is specified in the appropriate section of MBR documents.

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5.2 5.3

For the inspection of externally purchased parts, QC personnel will record the sample size on the receiving inspection "traveler" document. When samples are received in the QA/QC laboratory for inspection purposes, documentation of sample receipt must be performed according to 09-0188-SOP-1.0, QA/QC Sample Receipt and Identification.

6.

DEFINITIONS 6.1 6.2 Lot - a collection of units of product from which a sample is to be drawn and inspected. A lot may consist of single or multiple units. Sample - one or more units of product drawn from a lot, the units of the sample being selected at random without regard to their quality. The number of units of product in the sample is the sample size. Inspection - the process of measuring, examining, testing , or otherwise comparing the unit of product with the requirements. Sampling plan - the number of units of product from each lot which are to be inspected along with the criteria for determining the acceptability of the lot. Acceptance number - the largest number of nonconformities or nonconforming items found in the sample that permits the acceptance of the lot. Rejection number - the smallest number of non conformities or non conforming items found in the sample that requires that the lot be rejected. Switching rules - instructions with a sampling scheme for changing from one sampling plan to another of greater or lesser severity based on demonstrated quality level history. Defect - a departure of a quality characteristic that results in a product, process or service not satisfying its intended normal usage requirements. Nonconformity - a departure of a quality characteristic that results in a product, process or service not meeting a specified requirement. Attribute - a product or process characteristic that is judged as conforming or non conforming. Typically the acceptance criteria is expressed as pass or fail. Variable - a product or process characteristic that is measured in some manner. Typically the acceptance criteria is expressed as a range, minimum, maximum, or a mean with a tolerance range. Critical - a product or process characteristic is considered critical when a related defect or nonconformity causes the product to fail to meet its performance and/or safety design criteria.

6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 6.11 6.12 7.

GENERAL PRINCIPLES 7.1 Sampling plans are effective ways to judge the quality of a product lot without conducting 100% inspection. There are distinct advantages and disadvantages as follows: Economical advantage due to inspecting only part of the units in a lot Less handling damage or destruction during inspection Less labor intensive Less inspector error Encourages continuous improvement by lot rejection instead of discrete unit rejection Higher risk of accepting a bad lot and rejecting a good lot Increases planning, evaluation, and documentation requirements Provides information about the product, but not necessarily about the process making it. 09-0189-SOP-1.0 Page 2 of 5

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