The functional design of the Warehouse Management System (WMS) in regulated environments - Oqotech

The ultimate goal of process digitalization in any industry is to ensure and optimize processes, as well as to generate reliable information that allows decision making both to avoid incidents and to exploit competitive advantages. However, it is not enough to “install” computerized systems in the company to achieve the expected goal. We must ensure that these computerized systems, for example, warehouse management system, are adapted to the characteristics of the processes they must manage and work properly throughout their life cycle.

Just as important as the computerized system itself is the service provider, who provides support in the implementation of the computerized system, development of custom features, user training or support for incidents. We must ensure that the contracted service is defined, through signed agreements, and that it follows a quality policy in the management of its services in accordance with the requirements of the regulated sectors.

It is of vital importance to transmit to the service provider, and that he understands, the own characteristics of the business, the demands required to the software by the company and, in this sense, to unify criteria to facilitate the fulfillment of objectives.

One of the critical points to define with the service provider is the “customization” of the computerized system or developments to required measures. The tendency should be to implement the computerized system in the most standard way possible, but taking into account the essential requirements in order not to affect the quality of the product, process control or quality assurance.

Types of requirements for suppliers of Warehouse Management Systems

Before contacting the service provider or integrator of the computerized system, we must ask ourselves what requirements we are going to demand. At this point we always tend to define and require a specific operation, however, there are many types of requirements to be considered. Taking the definition of a warehouse management system (WMS) as a practical case, the following types of requirements could be defined:

• Technical

It is not the same to implement a technology of hand terminals, voice terminals, systems, for example, pick to light, etc. It is necessary to determine how you want to operate and make the decision based on the characteristics of the process. For example, handheld terminals will allow the same operator to perform a large number of different tasks, as he can easily select various tasks by navigating the screen. By contrast, voice technology can be highly recommended for operators who need to be hands-free and repeatedly perform a small number of tasks.

• Computer Scientists

Taking into account the compatibility of the computerized system with the organization’s IT infrastructure: operating systems, databases, processing equipment.

• Operational

Functionalities: screens, required information, type of confirmation, controls, algorithms, records, warnings, etc.

• Data and regulatory integrity

User management, security profiles, passwords, audit trail, electronic signatures, backup system, etc.

• Strategic

Taking into account the strategy defined by the organization.

Definition of the objective

Starting from a situation in a manual warehouse management work environment, let us define an objective in a computerized environment that is measurable and quantifiable in the short term:

What do we find in a company with manual processes?

• Paper process records.
  • It is true that everything is recorded, but the consultation in case of any incident can be expensive.
  • Another view is that these data cannot be exploited to obtain information on the situation and indicators at a grouped level in a simple way since they are on paper.
  • Moving them to Excel can mean time and errors in reprocessing. As well as making an Excel with a lot of data, which can begin to fail or jeopardize the integrity of the data by not having the necessary security and audit trail.
• Errors in manual data entry.
  • It is possible that errors are made in the confirmation of data on paper. Requires review and puts information integrity and traceability at risk.
• Paper-based in-process procedures and controls.
  • Requires marking of actions and in-process controls are on paper.
  • The operator’s attention is divided between the process and its record.
• Reprocesses, revisions and therefore doubts are generated.

What do we propose? A computerized environment.

• Defined process
  • That we form a team (with supervisors and process experts) and define the process that occurs. Important, both the standard process and the controlled incidents. In this way the operators are involved and trained and also improvisations are avoided.
• Guided process and executing in-process controls
  • If we enable as working tool terminals or screens that can interact with the user in the execution of the process.
    • First, we will be ensuring that the process is executed according to the methodology marked.
    • We can guide the operator in his operations (for example, specifying the package to be prepared).
    • And we can add controls in the process (confirm the prepared package, is the proposed or one suitable for what is required).
  • We avoid manual data entry by connecting to process equipment or reading bar codes. Every day more and more equipment already have a communication module and has declared the interface protocol to secure and facilitate data exchange.
  • We extract a real-time record of the actions that are confirmed. Recording both the data and its context (metadata): date and time of the action, operator, item and batch handled, amount of the movement and all the information of the action that we need. The fundamental factor for data integrity.
  • Possibility of extracting grouped information from the same process to observe trends and make predictions.

In order to define user requirements, we must have people who master the organization’s processes and can contribute all their knowledge and experience in different areas. Both at an operational level, and in supervision or management.

Standard requirements for a Warehouse Management System (WMS)

In the following, standard requirements for a warehouse management system (WMS) are determined:

Goods receipt:

The requirements for the area are then identified:

Requirement	Description
Forecast of entries and consultation of orders.	It is necessary that both office staff, such as responsible for administration, purchasing, warehouse, production, and quality, and plant staff, such as warehouse workers and quality technicians, can consult the updated information on the arrival of goods to the facilities in order to plan their activities in this regard. The query should be available both in the PC application and for mobile terminals (if available).
Arrival of goods.	Registration of the truck’s data and the date/time it arrives at the facilities. This requirement allows the truck of the transport to be traced and subsequently to be able to measure the compliance rate of the supplier’s service on the date. If a central truck entry gate is available, the functionality should be available in the PC application. Otherwise, the most flexible and convenient option for warehouse personnel is notification via the mobile terminal.
Verification of the truck and merchandise.	After the arrival and for the materials that require it, it must be possible to register the verifications applied to the truck, documentation provided by the supplier and the goods received. In this sense, a parameterized management of verifications is required, differentiating the department responsible (usually warehouse and quality), the time of control (in a dock or in offices after unloading) and the verifications that will be mandatory to be able to carry out the unloading of the goods. At the time of the control, the operator will be asked to confirm the result of each of the verifications, recording the user who executes the action, date/time and result of the verification. It must be possible to control changes in results.
Reception of the goods.	A complete recording of the data of the goods received. At this point, the option should be considered automatically entering, by means of barcode reading, the maximum information on the service provider’s label, in order to minimize manual data entry. Control of obligatory data by type of goods and compliance with specifications (for example, compliance with expiry dates and useful life).
Stock registration.	Once the information on the goods received has been confirmed, you must proceed to register the stock. At this point, the control of the logistic format must be required for the generation of the correct number of packages and pallets. Require the allocation of the internal lot automatically establishing the criterion differentiating by type of goods. As well as the linkage of the supplier batch with the generated internal batch.
Management of the identification of the merchandise.	At this point, the identification of each package (configurable at article level) must be required, as well as the identification of the pallets received.
Control of the physical and logical situation of the goods.	Control of the quality flow of the goods received by article type A possible flow of raw material could be that it was initially in a “pending sample” situation. When continuing with the use of the tool, it could later go to “quality control” and finally be “released” or “blocked”. The quality flow would refer to a “computerized” situation of each pallet of the received batch. It is also required to be able to know the physical location of each pallet: if it is in the dock, located, in transfer, etc. This situation will allow the control of the time spent by each pallet of the lot in the storage areas.
Generation of the internal delivery note.	Registration of delivery data, reflecting the data of the supplier and the goods received for invoicing.
Cancellation of deliveries.	An important requirement in the review of deliveries, prior to the release of the goods, is the possibility of canceling the receipt with a record of the reason and under the authorization of an authorized person. Deviation management of this process should be considered.
Returns to the supplier.	Management of the return of the received pallets to the supplier who delivers them. It is required to define the pallets of the return by an authorized person, the confirmation by barcode reading of the returned pallets and the generation of a record that controls the carrier, complete information of the loaded goods, operators involved and dates/times of the action.
Reports and KPIs.	Alerts of the different activities controlled in the process in order to facilitate communication between departments. Reports on delivery compliance, supplier service rate compliance (in date, quantity, and quality), dock saturation, operators, etc.

Internal logistics:

The area’s requirements are identified below:

Requirement	Description
Management of the warehouse map.	Identification of the physical areas of the facilities is required. Distinguishing the transit zones from the storage zones, identifying the different facilities: the docks, storage areas, transit zones, etc. At this point, it is recommended to opt for a detailed configuration in order not to compromise the control of the location of the goods, as well as to be able to guide the warehouse operators in a more concrete way.
Dedicated areas.	For the case that materials are available that cannot be in contact or close to other materials, or that only need to be stored in a specific area of the warehouse or require a specific storage temperature. The warehouse management system is required to have this control in the storage bin operation. If no storage bin is available for a material with a special storage need, a notification must be made for the management of this occurrence.
Location management.	Unique identification of storage bins of different capacities, volumes, temperatures or other parameters with the option of configuring whether it is possible to store more than one pallet, one or several items, from the same family, with or without batch mixing.
Pallet management.	Pallet Information: packages, physical and logical situation, stored material data. Allows confirmation of the movement of all stored packages.
Pallet location.	Guidance and control of pallet locations are required. Review of the algorithm for the required operation.
Stock Regularization.	The option to enable a configurable list of regularisation reasons is required and will be requested at the time of confirmation of the regularisation. Likewise, control of requirements of the material (that it is released, not expired, among others) to be able to control the types of regularization: sampling, pilot plant, etc. All stock movements require their corresponding registration: date/time, operators, information on the material, quantity, zones, equipment involved (such as scales), etc.
Reports and KPIs.	Alerts of the different activities controlled in the process in order to facilitate communication between departments. Reports on warehouse saturation, stock movements, near-expiry stock, rejected material, among others.

Production:

The requirements of the area are identified below:

Requirement	Description
Production orders.	The control of the production orders to be managed is required, differentiating typologies (production/packaging/conditioning orders, reprocessing orders, pilot plant orders, etc.)
Procurement of materials to production. Picking.	The preparation of materials for production is required, initially contemplating the option of supplying individually to the order, some materials in groups on a preparation beach or others without preparation required because they are stored in a warehouse or their consumption is controlled by a flow meter, load cells or similar.
Production returns.	Control of excess material in the order is required. Taking into account the material prepared for production (control of return parameters: article, batch, shelf life, and quantities). Management of the identification of the returned packages and the assigned storage spaces.
Finished product registration.	It is required that the warehouse management system allows the registration of the production in real-time. At the time of stock creation, the assignment of the relevant handling units, their coding, the assignment of the initial quality situation (for example “quality control”) will be required.
Identification of boxes and pallets.	It is required that the warehouse management system allows the registration of the production in real-time. In this sense, the intention is to define the design and content, at the item level, the configuration of the label of the different handling units (for example package, box, and pallet).
Closing orders.	Once the operations of the order have been completed, the stock has been recorded and the lines have been cleared, the system is required to close the order in order to avoid further movements on the order. In this way, reviewing and closing the order will block all associated information to ensure data integrity.
Management of movements in validated orders.	If an incident is detected in a closed order, for example, an unreturned material, an unrecorded decline or an unrecorded acquisition, a reopening is required. Reopening, on the one hand, allows you to record the non-conformity and manage the corrective actions. Reopening of orders is defined as functionality that allows, in a controlled manner, the authorization of one or more operators to execute movements on the order: for example, movements of assignment of material consumed to the order, material returned, or product manufactured. All these movements will have the usual controls and will be recorded in the WMS on a regular basis. Once the required movements have been completed, the order will be closed again and its information blocked.
Reports and KPIs.	Alerts of the different activities controlled in the process in order to facilitate communication between departments. Reports of preparation times, production, losses, etc.

Quality:

The area’s requirements are identified below:

Requirement	Description
Release or blocking of item-batches.	Functionality that allows the change of state of any material of the installation. The warehouse management system must allow, through the different selection criteria, to select all the articles, batch, pallets or packages to which the change of status will be applied. Control of the personnel performing this action will be required, sometimes (for finished product) with an additional electronic signature.
Substitutes	To manage absences of personnel authorized to perform certain regulated tasks, such as product release. The Warehouse Management System is required to be able to authorize, within a specified range of dates, substitute users according to the organization’s work center profiles and under the signature of authorized personnel.
Destruction and waste.	The warehouse management system is required to be able to authorize the packages to be destroyed by an authorized person, to confirm by barcode reading the packages for destruction and to generate a record that controls the carrier, complete information on the goods loaded, the operators involved and the dates/times of the action.
Reports on global traceability.	Alerts of the different activities controlled in the process in order to facilitate communication between departments. Reports on release times, non-conforming batches, destructions, etc.

Product dispatch:

The requirements of the area are identified below::

Requirement	Description
Sales orders.	Both office and warehouse staff need to be able to consult up-to-date sales order shipping information in order to plan their sales order assignments. The query should be available both in a PC application and for mobile terminals (if available).
Preparation management: full pallets and picking.	A preparation of goods for sale is required. Depending on the quantity requested, either preparation of full pallets to operators or preparation by picking is required. The picking algorithm must be analyzed in detail to ensure that the correct allocation of the batch/quantity to be picked is made on the one hand and that routes and warehouse movements are optimized on the other.
Identification of boxes and pallets.	Both for prepared full pallets or packing containers, the system will be requested to parameterize the resulting packages for shipment to the customer, as well as the final documentation to be attached.
Truck arrival.	Recording of the truck’s data and the date/time it arrives at the facilities or those that the trailer is assigned in case the truck is internal. This requirement allows the truck to be traced from the transport and subsequently be able to measure the rate of compliance with the customer service on the date. If a central truck entry gate is available, the functionality should be available in the PC application. Otherwise, the most flexible and convenient option for warehouse personnel is notification via the mobile terminal.
Truck check.	After arrival, it must be possible to record the verifications applied to the truck, its condition, and the physical conditions required for the shipment. In this sense, it is required a parameterized management of checks, differentiating the department responsible (usually warehouse and quality), and the checks that will be mandatory to carry out the loading of the goods. At the time of the control, the operator will be asked to confirm the result of each of the verifications, recording the user who executes the action, date/time and result of the verification. It must be possible to control changes in results.
Loading product into the truck.	Control of the loading of the prepared pallets. The system will be required to request confirmation from the operator performing the action, either by barcode reading or voice confirmation. The option of having to unload a pallet loaded by incidence and the revision of whether there is stock for replacement must be considered. It should also be considered the option, if applicable, of partial loads of the same order in several trucks or that several pallets finally prepared are not served due to lack of space.
Generation of the internal delivery note and associated documentation by client and type of product	All the documentation of the shipment must be executed once the pallets have been loaded, in order to evidence the final stock to be served. Likewise, the system will be requested to allow the configuration of the required documentation of the shipment taking into account the regulatory demands according to the product or the customer’s requirements.
Customer returns.	It is required to define the pallets of the return by an authorized person, the confirmation by barcode reading of the returned pallets and the generation of a record that controls the carrier, complete information of the goods, operators involved and dates/times of the action.
Reports and KPIs.	Alerts of the different activities controlled in the process in order to facilitate communication between departments. Reports on delivery compliance, customer service rate compliance (in date, quantity, and quality), dock saturation, operators, etc.

Security measures:

Below are the requirements for the area:

Requirement	Description
Management of users, security profiles and passwords.	Physical and/or logical controls must be incorporated to restrict access to computerized systems to authorized persons. The creation, change, and cancellation of an access authorization must be recorded. Data and document management systems should be designed to record the identity of operators entering, changing, confirming or deleting data, including date and time. Security profiles must be realistic and restrictive in permissions for critical actions. Each user must have an access password and this must meet minimum length and content characteristics.
Audit Trail.	Consideration should be given, based on risk management, to incorporating into the system the creation of a record of all relevant changes and deletions related to GMP (a system-generated audit trail). The reason for the change or deletion of relevant GMP-related data should be documented. The audit record must be available and generally convertible into an intelligible format, as well as regularly reviewed.
Electronic signature.	Electronic records can be signed electronically. With respect to electronic signatures, it is expected that: (a) have the same impact as handwritten signatures at the company level, (b) are permanently linked to the respective record, and (c) include the time and date when they were made.

Article originally published in the magazine Farmaespaña Industrial in October 2019.

At Oqotech we help companies, mainly in the pharmaceutical, cosmetic and medical devices sectors, to implement and validate computerized systems for the control and optimization of their processes.