Dynamic Modification of Inspection Scope, a White Paper

By Shashank Shekhar, Deloitte Consulting LLP

Significance of Dynamic Modification in Quality Management:

“Totality of characteristics of an entity that bear

on its ability to satisfy stated and implied needs”

Quality is defined and measured as function of usage and the business strives to maintain the tradeoff between the “conformance to specifications” and the “cost of quality”. In order to maintain the optimum quality level of a product, raw materials and other supplies it is important to consider the Quality Level based on the predefined specifications.

SAP Quality Management offers Dynamic Modification for the inspection scope functionality to optimize the efforts and costs required in quality inspection of materials. It is one of the most important features provided in Quality Management module. In real life scenario it is not feasible to inspect each lot of material at the time of goods receipt, goods issue or during in – process inspection. Dynamic Modification optimizes the quality inspection efforts while maintaining desired quality level.

Use of Dynamic Modification:

Dynamic Modifications are primarily used in Industries which have very high volume of Goods Receipt, Goods Issue transactions performed on daily basis and because of that  it is not feasible to inspect each sample from every vendor, manufacturer. It is practically impossible to inspect each lot of material supplied by a particular vendor or detailed inspection for each lot manufactured in a production line under similar conditions. While manufacturing, receiving or supplying a product to the customer, planning for maintaining appropriate and sustainable quality level is performed and at the same time business has to consider “Cost of Quality” as well. Dynamic Modifications are primarily used in the industries related to Pharmaceuticals, Chemicals, Food and Beverages, fast moving consumer goods, Automotive and others.

Dynamic Modification determines the sample size for an inspection using past inspection valuation so the past inspection valuation is used to calculate the current inspection scope. This is done using sampling procedure and dynamic modification rule. For a series of Inspection Lots dynamic modification rule can be used to control inspection scope (normal, reduced, tightened inspection) as well as to define skips in order to maintain agreed and predefined quality level with a high degree of certainty.

Dynamic Modification Criteria: The dynamic modification criteria are key fields that the SAP system uses to update the quality level. On the basis of these key fields, the system changes the sample sizes dynamically. 1. Material, 2. Material and customer, 3. Material and vendor, 4. Material and manufacturer, 5. Material vendor and manufacturer are the dynamic modification criteria established in system. The dynamic modification criteria is defined for the inspection lot origin in customizing and also it is defined in the Inspection Plan at the same level as Dynamic Modification Rule, the system uses the Dynamic Modification Criteria that is common to both objects to maintain the Quality Level. If the dynamic modification criteria is maintained as material and vendor in the inspection lot origin and in the task list the dynamic modification criteria is maintained as material, vendor and customer then at the time of goods receipt the quality level will be updated for a combination of material and vendor, in other case if in the task list (Inspection Plan) the dynamic modification criteria is maintained as material or material and customer then at the time of goods receipt the quality level is updated for material only because in this case only material is common dynamic modification criteria between inspection lot origin and the task list.

(Dynamic Modification Criteria in Customizing) .Picture

(Dynamic Modification Criteria in the Task List)

Dynamic Modification Level:

Dynamic Modification can happen at the Following levels,

A.    Dynamic Modification at Inspection Type Level

B.    Dynamic Modification at Inspection Lot level

C.   Dynamic Modification at Inspection Characteristics Level

For Dynamic modifications can be performed at Inspection Type level with or without task list the dynamic modification rule need to be maintained in the quality management view under inspection setting in the material master for the appropriate inspection type and also the dynamic modification level in the inspection plan.

For Dynamic Modification at Inspection Lot level the Dynamic Modification Level and Dynamic Modification Rule should be maintained in the task list at the header level.

(Dynamic Modification at Inspection Lot Level)

For dynamic modification at Inspection Characteristics Level, the dynamic modification level should be maintained at the Inspection Plan Header Level but the Dynamic Modification Rule should be maintained at the Inspection Characteristics Level.

(Dynamic Modification at the Inspection Characteristics Level)

Time of Dynamic Modification:

Time of Dynamic Modification is very important from the design perspective, it specifies the time when the quality level should be updated. The dynamic modification can happen at Inspection Lot creation as well as at Usage Decision. At the time of creation of Dynamic Modification Rule the timing of Dynamic Modification is decided.

1.    Dynamic Modification at Lot Creation:

When Dynamic modification at lot creation option is set in the Dynamic modification Rule the system automatically valuates the inspection lot with an “acceptance”, increases the number of successful inspections by one, and checks whether the conditions for a stage change have been met. If this is the case, a stage change is made in the quality level, which then affects the next inspection lot. If the inspection lot is rejected during inspection lot processing, the system updates the quality level for an unsuccessful inspection after the usage decision has been made.

Note: Dynamic Modification at Inspection Lot creation is mostly used with LIMS interface and when automatic usage decision is enabled for the inspection lots.

2.    Dynamic Modification at Usage Decision:

When the usage decision is made for the current inspection lot, the system updates the quality level and evaluates the condition for an inspection stage change based on the dynamic modification rule and depending on the result of the current inspection lot it determines whether or not inspection stage change should occur.

Dynamic Modification Rule:

Dynamic modification rule is the master data which contains definition of the inspection stages and conditions that lead to a change in the inspection stage. We assign the dynamic modification rule in the task list header, at the characteristic level of a task list, or in the QM inspection data of the material master.

Picture 1

(Dynamic Modification Rule with Inspection stage changes Normal Inspection, Reduced Inspection, Skip and Tightened Inspection)

Picture 2

(Definition of each inspection stage along with the rules for the stage change)

Note: With Allowed Relationship combination of Sampling Procedure with Sampling Scheme and Dynamic Modification Rule can be maintained for a material inspection.

Usage of Dynamic Modification:

1.    Automatic Change of Inspection Stage from Normal Inspection to reduced inspection after a series of acceptance for the inspection lot, thus reducing the quality cost for the material inspection.

2.    Automatic change of Inspection stage from reduced to “Skip” after a series of successful inspection to save productive time and cost incurred in the inspection.

3.    Automatic change of Inspection Stage from Reduced or Skip to Normal or Tightened to ensure the Quality of the Product.

Example of usage of Dynamic Modification with skip functionality:

Settings related to Dynamic Modification Rule:

DMR stage change settings or stage 10                         DMR stage change settings for stage 20

                                         

Process Flow Diagram: The process flow explains the skip functionality designed for Goods Receipt Inspection with purchase order process:

  1. Initial stock of material 2069 is displayed via transaction MMBE

There is no stock for the material in either unrestricted or quality inspection stock

  1. A purchase order 4200003426 created for the materials and goods receipt was made against the purchase order,
  1. Material Document 5000004609 was posted and an Inspection lot 10000002218 was created and the material is moved to the Quality Stock. The transaction MMBE displays the material in the Quality Stock
  1. Usage decision is performed for the Inspection Lot and the material is moved to unrestricted stock from the quality stock
  1. Now again other Purchase Orders are created the PO Numbers  4200003427, 4200003429, 4200003430
  2. Now Goods receipt is made against the purchase order 4200003427

  

  1. Material Document 5000004612 is posted and Inspection Lot 10000002220 is created and the material is moved directly to unrestricted stock as the inspection lot was skipped.

This process will work for all goods receipts, the materials will be directly posted to unrestricted stock unless there is any rejection. When the UD code Rejected will be used then in that case as per the dynamic modification rule the next goods receipt will post the material in the quality stock instead of unrestricted stock.

  1. Performing the Goods Receipt posting for the PO 4200003429
  2. Material  Document  5000004613 is posted and Inspection Lot 10000002222 is created and the material is moved to unrestricted stock
  1. Now rejecting the Inspection Lot 10000002222, the stock of 100 no will move to the blocked stock

  1. Now when the Goods Receipt is made against the second PO 4200003430, the inspection lot will not be skipped and the system will post the material in quality Inspection and once the UD is performed for the material, it will be posted to the unrestricted stock and after that all the subsequent inspection lots will be skipped.

                                                                                                                                                                                

  1. Usage decision for the skipped Inspection Lots: It is proposed to schedule a background job for the automatic decision for skipped lots. Create a  variant  for the program RQEVAI10 with the desired usage decision codes to be used for the usage decision for the skipped lots and then schedule a periodic  background job for the automatic usage decision.
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10 Comments

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  1. Sanjay Choubey

    This is excellent information, which will definitely be helpful to me and my organization. Getting the concise information about Quality Control rules will be helpful to maintain Quality control in my company, which is very crucial.

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  2. Atul Jain

    I find this Quality Management documentation is very useful and informative. And I recommend this to people in chemical / pharma industry.

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