TITLE: SELF-INSPECTION PROCEDURE

PROCEDURE NO.: 303-10-A
DRAFT

1. Purpose

To document the program of planned periodic self inspections performed to ensure compliance to established Corporate procedures and policies, government regulations, and consumer requirements.

2. Scope

The program includes both internal and external inspections. This program supplements the audit performed by Corporate Quality Assurance.

3. Responsibility

3.1.

Plant Manager ensures that an effective self inspection program is in operation.

3.2.

Quality Control Manage develops a self inspection program and verifies, through review of Inspection Log, that scheduled activities are implemented.

3.3.

Team Leader performs the self inspections per this procedure, documents all pertinent observations, and follows up on any corrective actions.

4. Definitions

   4.1.

   Self Inspection - an investigation to determine the adequacy of and adherence to established procedures, instructions, specifications, and standards.

   4.2.

   External Inspection - investigation, usually in a specialized subject, performed by qualified outside consultant approved by the Quality Control Manager.

   4.3.

   Internal Self Inspections - performed by responsible members of the staff, primarily Production Supervisors and members of Quality Control.

   4.4.

   Team Leader - outside consultant or responsible member of Production or Quality Control assigned to perform and document self inspections.

   4.5.

   Process Compliance Check - inspection to show adherence to operating procedures. Examples include Sanitation Inspections and Formula Compliance Checks.

   4.6.

   System Compliance Check - inspection of documentation of a procedure or operation, usually performed in the office of the subject area or of the Team Leader. Example: Cleaning Attainment.

5. Procedure - Internal Inspections

   NOTE: Due to the "surprise" nature of some of the inspections, the inspection will follow immediately after the Team Leader’s announcement. Attachment I gives a list of the inspections, with the frequency and review mechanism for each.

   5.1.

   At the assigned frequency, the Team Leader informs the area supervisor that an inspection will take place, and sets a mutually convenient time.

   5.2.

   Before conducting the inspection, the Team Leader reviews the relevant procedures, GMPs, Technical Directions, and other documents, and reviews file for observations still open from previous inspections.

   5.3.

   Team Leader informs area supervisor of arrival in area and conducts the inspection.

   5.4.

   At the conclusion of the inspection, the Team Leader briefly reviews the inspection with the area supervisor, stressing areas which need immediate correction.

   5.5.

   Team Leader prepares inspection report, mentioning any corrective actions taken during the inspection. When report is complete, destroys all notes and preliminary drafts.

   5.6.

   Team Leader issues report stamped CONFIDENTIAL and schedules a meeting to review results.

   5.7.

   On receiving of an inspection report, the QC Department Secretary enters in the Inspection Log the name of the report, the name of the Team Leader, and the date the report was issued.

   5.8.

   At meeting, team members discuss any necessary corrective actions and establish a timetable for completion.

   5.9.

   When corrective actions are complete, the inspection report is destroyed.

6. External Inspection

6.1.

Inspections performed by outside consultants follow the same format as internal inspections except for the following:

6.2.

The team co-leader accompanies the outside consultant throughout the inspection.

6.3.

At the review meeting, the outside consultant leaves a preliminary report. A formal report follows.

6.4.

The co-leader follows up on any action items specified in the report.

INTERNAL INSPECTION

Written by:

Approved by:

©Copyright Warner Lambert 1983

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