Standard Operating Procedure (SOP) for Acceptable Quality Level (AQL)

Cleaning of High Performance Liquid Chromatography (HPLC)

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the guidelines and procedures for determining and maintaining the Acceptable Quality Level (AQL) in [Company Name] manufacturing processes. This SOP aims to ensure consistent product quality, reduce defects, and meet customer expectations.

2. Scope

This SOP applies to all manufacturing processes, including but not limited to production, assembly, and inspection, within [Company Name]. It encompasses the establishment of AQL levels, sampling procedures, and decision-making processes regarding product acceptance or rejection.

3. Definitions

3.1 Acceptable Quality Level (AQL):

The maximum allowable number of defects or non-conforming units in a sample, beyond which the lot is considered unacceptable.

3.2 Lot:

A group of products or components produced under similar conditions and intended for the same purpose.

3.3 Sampling Plan:

A predetermined procedure for selecting a subset of items from a lot for inspection and quality assessment.

4 Determining AQL Levels

4.1 Prior to initiating production, the Quality Control team, in collaboration with relevant stakeholders, shall determine the appropriate AQL levels based on product specifications, customer requirements, and industry standards.

4.2 AQL levels shall consider critical, major, and minor defects, as well as associated risks and potential impact on end-users.

5. Sampling Plan Development

5.1 The Quality Control team shall establish appropriate sampling plans using recognized statistical methods such as ISO 2859 or MIL-STD-105E.

5.2 The sampling plan shall specify the sample size, inspection level, and acceptance/rejection criteria based on the determined AQL levels.

6. Sampling Process

6.1 During production, designated inspectors shall follow the approved sampling plan to select random samples from each lot.

6.2 Inspectors shall record the observed defects and compare them to the acceptance/rejection criteria specified in the sampling plan.

7. Decision-Making and Reporting

7.1 If the number of defects in the sample falls within the AQL limits, the lot is accepted for further processing or shipment.

7.2 If the number of defects exceeds the AQL limits, the lot is subject to further investigation, corrective action, and potential rejection.

7.3 The Quality Control team shall document inspection results, communicate findings to relevant departments, and initiate corrective actions when necessary.

8. Periodic Review

8.1 The established AQL levels and sampling plans shall be periodically reviewed by the Quality Control team to ensure their effectiveness and alignment with changing product requirements or customer expectations.

9. Data Analysis and Improvement

9.1 The Quality Control team shall analyze historical data to identify trends, patterns, and opportunities for reducing defects and enhancing product quality.

9.2 Continuous improvement initiatives shall be undertaken based on data analysis, including process optimization, employee training, and supplier collaboration.

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