You dont have javascript enabled! Please enable it! MAN-090 Scheduling of Production Lines Pharmaceuticals quality assurance & validation procedures GMPSOP

MAN-090 Scheduling of Production Lines

DepartmentManufacturingDocument noMAN-090
Prepared by: Date: Supersedes: 
Checked by: Date: Date Issued: 
Approved by: Date: Review Date: 

 

Document Owner

Operations Manager

Affected Parties

All planning and production Managers

Purpose

The purpose of this SOP is to outline a 12months Production plan through the Weekly schedule.

Scope

It is the responsibility of the Planner Buyers and Production Managers to ensure the system described in the SOP is properly designed to meet all requirements of the Business Plan.

The Objectives of the Scheduling process is to:

Produce a monthly manufacturing schedule following an agreement 12 months plan.

Provide a sequence of work that will enable the scheduling of support groups (i.e. Quality, Technical and Warehousing).

Incorporate any planned engineering down time (i.e. Project work, calibration and preventative maintenance).

Create and release batch orders (BPN) according to the agreed weekly schedule.

Provide a weekly meeting to ensure all key activities are coordinated between Planning, Operations and Procurement and other support groups.

Provide key dates for product supply to support Customer Service.

Key assumptions for this process are:

a. 12-month plan is valid.

b. Product wise Bill of Materials and routings are valid.

c. Purchasing Plans are valid.

d. Inventory accuracy is within tolerances.

e. Schedules of Engineering Work are valid and completed on time.

f. Support groups (i.e. QA/QC and Warehousing) complete work according to planned lead-times.

g. Adequate resources are provided to operational areas.

Definition

BOMBill of Materials
PMPreventative Maintenance
MFGManufactured Finished Good
KPIKey Performance Indicator
BPNBatch Production Number
QA/QCQuality Assurance / Quality Control
WIPWork-in-Progress

 

Related Documents

Form-235Monthly Production Schedule Form

 

EHS Statement

This is a documentation procedure and there is no EHS impact.

Procedure

1. Cycle Overview

1.1.         The process commences with the previously agreed 12 months schedule being used for the weekly cycle of batch order release and schedule meetings.

1.2.         By the middle of the month the previously agreed 12-month rolling plan (beginning of the year) is used to prepare a detailed schedule for the up coming month.  Any batch orders (BPN) in the current month that will not be completed due to any reason(s) (ie. Quality, process issues, machine constraints, engineering work, component availability, etc) is rescheduled out into the upcoming month or appropriate date.  Customers affected are notified of possible delays.  Any preventative maintenance (PM), calibration and project work is fine-tuned in the up coming month.  The proposed schedule is published and reviewed by production with comments and actions agreed.

1.3.         In the Monthly Capacity Meeting review the monthly schedules.  In the meeting, the Production Managers “sign-off” on the plan for the upcoming month.  Monthly performance measures are also reviewed.  At the end of the month, the reasons for any missed customer service are reviewed and new ship dates are issued to the customers.

1.4.         The Planner creates all Batch Production Numbers (BPN) for a rolling 5 – 7 workday forward view.

1.5.         The Production managers release all BPNs as created by the Planner.

1.6.         Listed below is process flow for the Monthly Cycle.

Figure

2. Weekly Cycle

Within the month, the weekly cycle is completed and has the objectives of the following:

2.1.         Planner creates batch orders (BPN) to production by the agreed release period (i.e. 5 to 7 working days in Manufacturing).

2.2.         Production Manager releases BPN to process lines by the agreed release period ( i.e. 5 to 7working days in production).

2.3.         Managing carry-over or improved output from one week to the next.

2.4.         Keeping Minutes of the agreed actions required by production and support groups to attain schedule completion as discussed in the weekly schedule meetings.

2.5.         Ensure that Operations and support groups have a current schedule to ensure all parties know the priority and sequence of work being executed in production.

2.6.         Update any Customer Service promise dates and back-orders for materials scheduled for production.

2.7.         Review of weekly meetings to ensure co-ordination of operational activities with the schedule, between Planners, Production Managers and support group Managers.

Figure

3. Cycle Detail

3.1.         The process commences with the previously agreed weekly schedule being used for batch order creation by the Planner.

3.2.         By the middle of the week, new process orders are created that cover the next 5 to 7 working days.  Actual production for the week is reviewed and an estimation of the week ending position is made with production during the Weekly Schedule Meetings.

3.3.         The Weekly Schedule Meetings is held.  At this meeting the next week’s work is reviewed (ie. all released BPN) and the actual weekly performance is reviewed.  Actions are agreed to support production in achieving the coming weeks schedule with the longer-term objective of meeting the monthly plan target output.

4. Performance Measures

4.1.         WEEKLY Output to Plan (OTP)

The signed-off monthly plan forms the basis for the Weekly Output to Plan measure.  To be regarded as a “hit” a batch must be completed within the given week, with a yield meeting the target for the process.

5. Summary of Changes

Version # Revision History
MAN-090 New