How to setup process flows, PFMEAs & control plans

Managing PPAP documentation is one of the most time-intensive parts of supplier quality compliance. Whether your organization is certified to IATF 16949, AS9100, or ISO 13485, the volume of required documents , from Process Flow Diagrams to PFMEAs and Control Plans , can be difficult to maintain consistently.

1factory streamlines this process by allowing you to build a master library of process templates that automatically populate into part-specific documents. This reduces duplicate effort and ensures lessons learned are captured and applied across all parts that share a common process.

 1. PPAP processes

The first step is to set up your master list of processes in the PPAP Processes tile within the Master Data tab. These master processes serve as reusable templates across all part-specific PPAP documents.

1.1 Process flow master

Once you are in the PPAP Processes tile, you can begin identifying the processes used to produce your product.

To create a new process:

• Click the New PPAP Process button.
• Fill in the details for the process being created.
• Click GO to save.

1.2 Master PFMEA, process control plan & product control plan

Once a process has been created, you can build the associated master documents. Click on a process from the list to open it and manage its core documents.

To add a new failure mode in the PFMEA:

• Click the Add Row button on the left ribbon.
• To remove a row, select it and click Remove Row.

Failure modes added to the Master PFMEA will automatically populate when creating a part-specific PFMEA.

RPN color scheme

RPN range	Indicator
Less than 100	GREEN
100 to 150	YELLOW
Greater than 150	RED

Note: 1factory uses a lessons-learned approach for the Master PFMEA and Process Control Plan. The intent is to build out your master documents as fully as possible and update them as new failure modes are identified. This ensures that all parts sharing a common process benefit from accumulated quality knowledge. 

To add controls to the Master Process Control Plan, click Add Row on the left ribbon. Controls added here will automatically populate into part-specific Control Plans. Within a part-specific plan, you can also add or remove rows to reflect part-level variations.

Note: The Master Process Control Plan is intended for process-related characteristics such as injection pressure, clamping force, and temperature. Under the Master Product Control Plan you can define a commonly used Machine, Control Method, Reaction Plan, and Tool Path.

Similarly, To add controls to the Master Product Control Plan, click Add Row on the left ribbon. Controls added here will automatically populate into part-specific Control Plans. Within a part-specific plan, you can also add or remove rows to reflect part-level variations. 

2. Creating part-specific process flows, PFMEA & control plans

2.1 Defining the operations sequence

To create part-specific PPAP core documents, start by defining the operations sequence within your manufacturing plan. Operation sequences are set in the shaded operations column of the manufacturing plan. You can define operations per feature or use the group edit feature to streamline the process.

2.2 Create a new PPAP core document

From the main dashboard:

• Click the Manufacturing module.
• Click PPAP Core Docs.
• Click New PPAP Core Doc to create a new document for the part, using the operations defined in step 2.1

Note: When creating a new PPAP Core Doc type , you will be prompted to select a standard format.

•  If you are selecting ISO 13485 (Med Device) enables two additional columns in the Process Control Plan and Product Control Plan: OQ# (Operational Qualification, validates a spec) and PQ# (Performance Qualification, validates the method). The Tool Path column is also available in this format. These columns support validation documentation requirements specific to medical device organizations.
• If you select AIAG/AS9100 format when your organization is certified to AS9100 Rev D or IATF 16949, or when your customer has not specified a different PFMEA standard. It is the broadest-applicable format and the one most quality engineers will recognize from prior PPAP submissions.
• If you select the AS13100 format when your customer has explicitly referenced AS13100 in their Supplier Quality Requirements (SQR) or Purchase Order terms, or when your organization supplies to a program governed by Boeing D6-82479 or an equivalent OEM quality flow-down. If your customer has not specified AS13100, the AIAG/AS9100 format is the appropriate default for aerospace suppliers.

2.3 Defining the process flow

Navigate to the Process Flow tab. For each operation sequence, select which process from your master library applies. This links the part-specific document to the master process templates configured in section 1.

2.4 Defining the PFMEA

Select the PFMEA tab to define part-specific failure analysis. Fields include Potential Failure Mode, Potential Effects of Failure, Severity, Potential Causes of Failure, Occurrence, and Detection… e.g. You can add or remove rows as needed to match your process design.

---

2.5 Defining the process control plan

Select the Process Control Plan tab to define process-level controls for each operation. Available fields include:

• Product Characteristic
• Special Characteristic classification
• OQ# (Operational Qualification, validates a specification) and PQ# (Performance Qualification, validates the method), for organizations using the ISO 13485 (Med Device) standard
• Tool Path (free text) for medical device organizations
• Control Method, Evaluation type, and Sampling Size

You can add or remove rows to reflect your specific process design.

---

2.6 Defining the product control plan

Select the Product Control Plan tab to define product-level controls. Fields available include Machine, Device, Control Method, Reaction Plan, Evaluation, Sampling Size, OQ#, PQ#, and Tool Path (for ISO 13485 Med Device organizations).

---

2.7 Approving and releasing the documents (optional) 

Before PPAP core documents can be used in production, they must go through a cross functional approval & release process. 

Configure the Mandatory Approver Role(s)

An approver must be assigned at the organization level before any document can be submitted for approval. This is done once in Settings and applies across all document approvals.

1. Click your user name in the top right corner of the screen and select Settings from the dropdown.
2. Scroll to the PPAP Settings section.
3. Locate the Default approval Roles for PPAP Core Docs field and select from the dropdown which roles are required to approve an revision of the PPAP Core Docs. Users assigned to this role will appear in the approver selection list when documents are submitted for approval.
4. Click Save.

To complete the approval workflow:

• Click the Manage tab.
• In the Approver dropdown, select the appropriate approver.
• Click Pending Approval, then click Save.
• Once reviewed, click the Approved button to certify the document.
• Click the Released button to make the document active and available for use.

Once released, data from the Process Flow, PFMEA, Process Control Plan, and Product Control Plan will be available and linked to the corresponding part-specific operations.