Before your organization begins utilizing 1factory’s QMS modules, there are a few steps to ensure a smooth transition from your current system to the new QMS within 1factory. In the section below, we have detailed these steps for your convenience.
1.1 Setting up the List of Values (LOV)
1factory allows users to configure their accounts to better match their organizational structure. To achieve this, 1factory has developed what we call the “List of Values”. You can find the List of Values by navigating to the Master Data tab and clicking on the yellow List of Values tile.
Once you are in the List of Values tile, you will find three QMS-related Lists of Values to fill out before uploading any documents into the QMS. We have explained how each is intended to be used within 1factory. To simplify this process, we have provided a pre-formatted file that you can complete and automatically import into your 1factory account. You can find the link to the file at the bottom of this article title: QMS_Lov's.
1.1.1 Standards Organization
The Standards Organization List should be configured to reflect any external party whose requirements your QMS needs to meet, such as the International Organization for Standardization (ISO) or a customer. Please note that this list is to identify the organization and NOT the standard. For example, the list should state “ISO” and NOT “ISO 9001:2015.”
1.1.2 Business Function
The Business Function List should be established to accurately reflect the business processes that comprise your QMS. These are usually departments within your organization, such as "Human Resources" or "Engineering." This list will later be used to identify which business function each QMS document is associated with.
1.1.3 QMS Roles
The QMS Roles List should be created to accurately reflect the organizational roles within your QMS. These roles typically align with job descriptions or positions in your organization, such as "HR Manager" or "Machinist." This list will be utilized for assigning roles to users, facilitating the document approval process, assigning training responsibilities, and demonstrating ownership of QMS documents. Users may hold multiple roles as needed.
1.2 QMS Settings
To access these settings, click on your name in the top-right corner of the screen and select Settings.
Once inside your settings, you'll find various QMS settings as described below:
- Mandatory Approver Role: The selected QMS role will be required as an approver for all changes to controlled documents (such as Standards, Procedures, Work Instructions, and Forms) within the QMS.
- Use alphabetic revisions: This setting controls the revision sequence format for QMS documents. When set to "No" (default), all QMS documents will follow a numerical revision sequence. When set to "Yes", QMS documents will follow an alphabetical revision sequence.
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Document Numbers: This setting drives the QMS documentation naming structure by selecting one of the options below.
- 1factory numbers: Each document will follow 1factory's default format of document type followed by the next sequential number (e.g., Procedures = PRO-1, Work Instructions = WI-1, Forms = FRM-1). This option may be helpful for organizations building their QMS from scratch.
- 1factory with legacy numbers: Each document will follow 1factory's default format (PRO-1) and additionally include a label field to trace back to the legacy document number. This option is useful for companies that wish to utilize the 1factory naming convention for QMS documents while maintaining traceability of QMS documents at the time of change.
- Your own numbers: ach document will follow your organization's existing QMS document naming convention. By choosing this option, you can add your organization's document prefixes per document type by adding them to their respective document type settings, separated by commas. Any new documents created with the prefixes identified in the settings will be automatically assigned the next sequential number.
- Allow external files as documents: Organizations that wish to upload legacy documents (PDF) as controlled documents when creating QMS documents in 1factory, rather than creating them from within 1factory, should set this option to "Yes".The user will still be able to utilize 1factory to create documents as their discretion.
- Periodic Document Reviews: By setting this to "Yes", users can set a time period (in months) for when documents require review. This feature is typically used in QMS systems that require full review of the QMS during their certification cycle. When a document review is required, document owners can indicate whether changes are needed or not.
1.3 Importing Documents
The next step in going live with your QMS is to migrate your documents from your current system into 1factory. We understand the importance of careful planning for such a change to your QMS, so we have created an automated process to help you migrate your QMS documents into our system while retaining key traceability information.
Documents in 1factory are organized into several categories, or "Lists," which can be accessed by navigating to the QMS tab and clicking on the Documents or Mfg. Document tile. Below, we explain the purpose of each list and outline the process for importing documents into 1factory.
Note: If your organization would like to build your QMS from scratch within 1 factory, please bypass this section and directly to section 2.0.
1.3.1 Standards
The Standards list is designed to store all external standards and requirements that your QMS must comply with. These can include regulatory standards, such as ISO 9001:2015, as well as customer-specific requirements, like a supplier quality manual. To simplify this process, we have provided a pre-formatted file that you can complete and automatically import into your 1factory account. You can find the link to the file at the bottom of this article title: QMS_Standards_Parser.
- No.: Documents will follow either the 1factory number format (STD-1, STD-2, …) or Your own numbering format based on the prefixes defined in your organization settings.
- Legacy No.:If legacy numbering is chosen in the settings, users will have a label field to trace back to their legacy document number from before the transition to 1factory. This provides traceability when migrating from your previous QMS into 1factory's QMS.
- Standard No. & Rev.: Document number and Revision of the external document.
- Title: Name of the external document you wish to control with the QMS
- Type: Indicate whether the document is Regulatory or Customer.
- Issuing Org.: Organization that owns the external standard or requirement. For example, SAE is the Issuing Org. for the AS9100 D Standard.
- Owner: QMS Role responsible for ensuring the requirements of the document are met.
- Revision: The Revision in which your document is at when migrating to 1factory.
1.3.2 Procedures
The Procedures list is designed to store all internal documents that outline the operation of your Quality Management System, such as standard operating procedures, policies, and manuals. These documents will also later be used to demonstrate compliance with external requirements listed in the Standards list by establishing automatic linkage. To streamline this process, we offer a pre-formatted file that you can fill out and import directly into your 1factory account. You can find the link to the file at the bottom of this article title: QMS_Procedures_Parser
- No.: Documents will follow either the 1factory number format (PRO-1, PRO-2, …) or Your own numbering format based on the prefixes defined in your organization settings.
- Legacy No.: If legacy numbering is chosen in the settings, users will have a label field to trace back to their legacy document number from before the transition to 1factory. This provides traceability when migrating from your previous QMS into 1factory's QMS.
- Title: Name of the procedure you wish to control with the QMS
- Business Function: Specifies the Business Function to which the Procedure pertains. This must correspond with the List of Values within 1factory.
- Owner: QMS Role responsible for ensuring the requirements of the Procedure are met. This must correspond with the List of Values within 1factory.
- Revision: The Revision in which your document is at when migrating to 1factory.
1.3.3 Work Instructions
The Work Instructions list stores internal documents that offer detailed steps and information on how to perform specific within your QMS Business Processes. For example, a Work Instruction on "Creating a new supplier in the QMS" might be referenced within the "Supplier Qualification" Procedure. These documents can be cross-referenced within the QMS, automatically creating links between them. To streamline this process, we offer a pre-formatted file that you can fill out and import directly into your 1factory account. You can find the link to the file at the bottom of this article title: QMS_Work_Instructions_Parser
- No.: Documents will follow either the 1factory number format (WI-1, WI-2, …) or Your own numbering format based on the prefixes defined in your organization settings.
- Legacy No.: If legacy numbering is chosen in the settings, users will have a label field to trace back to their legacy document number from before the transition to 1factory. This provides traceability when migrating from your previous QMS into 1factory's QMS.
- Title: Name of the work Instruction you wish to control with the QMS
- Business Function: Specifies the Business Function to which the Work Instruction pertains. This must correspond with the List of Values within 1factory.
- Owner: QMS Role responsible for ensuring the requirements of the Work Instructions are met. This must correspond with the List of Values within 1factory.
- Revision: The Revision in which your document is at when migrating to 1factory.
1.3.4 Forms
The Forms list is used to store documents that will later become Records within 1factory. For example, the Work Instruction for "Creating a New Supplier in the QMS'' may reference a form called "New Supplier Audit Form." To streamline this process, we offer a pre-formatted file that you can fill out and import directly into your 1factory account. You can find the link to the file at the bottom of this article title: QMS_Forms_Parser
- No.: Documents will follow either the 1factory number format FRM-1, FRM-2, …) or Your own numbering format based on the prefixes defined in your organization settings.
- Legacy No.: If legacy numbering is chosen in the settings, users will have a label field to trace back to their legacy document number from before the transition to 1factory. This provides traceability when migrating from your previous QMS into 1factory's QMS.
- Title: Name of the Form you wish to control with the QMS
- Business Function: Specifies the Business Function to which the Form pertains. This must correspond with the List of Values within 1factory.
- Owner: QMS Role responsible for ensuring the requirements of the Forms are met.This must correspond with the List of Values within 1factory.
- Revision: The Revision in which your document is at when migrating to 1factory.
1.3.5 Process
The Process list stores internal documents that provide detailed steps and information on how to perform specific tasks within your manufacturing process. For example, a Process Instruction may be created for "Post-Machining Part Cleaning: Ultrasonic Wash Station". These instructions can then be easily linked to multiple Manufacturing and/or Receiving Plans within 1factory's Quality Control modules. To streamline this process, we offer a pre-formatted file that you can fill out and import directly into your 1factory account. You can find the link to the file at the bottom of this article title: QMS_PRI_Parser
- No.: Documents will follow either the 1factory number format PRI-1, PRI-2, …) or Your own numbering format based on the prefixes defined in your organization settings.
- Legacy No.: If legacy numbering is chosen in the settings, users will have a label field to trace back to their legacy document number from before the transition to 1factory. This provides traceability when migrating from your previous QMS into 1factory's QMS.
- Title: Name of the Process Instruction you wish to control with the QMS
- Business Function: Specifies the Business Function to which the Process Instruction pertains. This must correspond with the List of Values within 1factory.
- Owner: QMS Role responsible for ensuring the requirements of the Process Instruction are met. This must correspond with the List of Values within 1factory.
- Revision: The Revision in which your document is at when migrating to 1factory.
1.3.6 Part Specific
The Part Specific list stores internal documents that provide detailed steps and information on how to perform tasks within your manufacturing process for a specific Part Master. For example, a Part Specific Instruction may be created for "Plunger Assembly Steps" for Part Master 12-5039 C. These instructions can then be easily linked to any Manufacturing and/or Receiving Plans that use the referenced Part Master within 1factory's Quality Control modules.To streamline this process, we offer a pre-formatted file that you can fill out and import directly into your 1factory account. You can find the link to the file at the bottom of this article title: QMS_Part_Parser.
- No.: Documents will follow either the 1factory number format PTI-1, PTI-2, …) or Your own numbering format based on the prefixes defined in your organization settings.
- Legacy No.: If legacy numbering is chosen in the settings, users will have a label field to trace back to their legacy document number from before the transition to 1factory. This provides traceability when migrating from your previous QMS into 1factory's QMS.
- Title: Name of the Part Specific Instruction you wish to control with the QMS
- Part Number:The Part Master in which the Instruction is used for.
- Business Function: Specifies the Business Function to which the Part Specific Instruction pertains. This must correspond with the List of Values within 1factory.
- Owner: QMS Role responsible for ensuring the requirements of the Part Specific Instruction are met. This must correspond with the List of Values within 1factory.
- Revision: The Revision in which your document is at when migrating to 1factory.
1.3.7 Importing the Document List
After you have gathered all of the information in the documents list you wish to migrate into 1factory, you can now begin to import each file into their respective documents list.
To do so, navigate to the list of documents you are importing and click on the Excel Import button found at the bottom of the left-hand sidebar as seen below. Once clicked, a slideout will open where you can click on the green paper clip icon to attach the file. Repeat these steps for each documents list.
1.4 Assigning QMS Roles
The next step in getting your QMS up and running is to assign the QMS Roles previously defined in your list of values to the users within your organization Users List. The User List can be found by navigating to the Master Data tab and then clicking on the Users tile.
After accessing the Users list, click on the user you want to assign a QMS Role to. Once selected, navigate to the QMS Roles tab, and a slide-out panel will appear. From the dropdown, choose the QMS Role you'd like to assign to the user.
Note: Users may be assigned multiple roles within the QMS, depending on their responsibilities.
1.5 Go Live Release
Now that you have your QMS framework within 1factory, you can begin to build the content of your QMS documentation and start releasing documents to production. The following sections detail how documents are developed and released to production.