1factory's quality management solutions serve precision injection molders producing critical components for the most demanding applications — from aerospace structures and defense systems, to life-saving medical devices, to high-volume automotive components where process control determines profitability.
Supported Standards: 1factory supports all key plastics manufacturing standards, including PPAP/APQP (Automotive), AS9100 (Aerospace Quality Systems), ISO 13485 (Medical Devices), and ISO 9001.
Security and Hosting Environments: 1factory is hosted on the AWS GovCloud and provides a FEDRAMP Moderate Equivalent hosting environment (3PAO audit in progress as of Feb 2026). For manufacturers with classified data or sensitive IP, we provide an option to host 1factory on-premise.
For Aerospace & Defense Injection Molding
Companies Like: Allegheny Performance Plastics, premium molders serving Boeing, Lockheed Martin, Northrop Grumman, Raytheon, General Dynamics, and emerging defense contractors requiring high-performance polymers for flight-critical and mission-critical applications
Key Challenge: Aerospace and defense molders face unique quality demands that go far beyond typical plastic parts manufacturing. You're processing high-performance polymers — PEEK, PPS, PEI (Ultem), LCP, and other exotic resins — with material costs that can exceed $100 per pound. Parts may have hundreds of critical dimensions, complex geometries, and requirements for complete material traceability from resin lot to finished assembly. Traditional paper-based or disconnected quality systems create massive risk: a single out-of-spec part discovered after a production run means scrapping expensive material, missing delivery commitments to aerospace OEMs, and potentially losing qualification status that took years to achieve.
Key Functionality
Real-Time SPC for Process Control: High-performance polymers are unforgiving. Process windows are narrow, and deviations quickly produce defective parts. Traditional approaches — collecting measurements on paper, batch-uploading to SPC software hours or days later — mean problems are discovered only after significant production has occurred.
1factory eliminates this lag entirely. As operators inspect parts on the production floor using digital calipers, micrometers, or vision systems, SPC control charts update in real-time. Statistical indicators calculate instantly, triggering automatic alerts the moment data suggests process drift. Cpk values update continuously, providing current process capability rather than outdated numbers from yesterday's batch.
For molders running high-value resins, this real-time visibility prevents catastrophic scrap events. When control charts show upward drift in a critical wall thickness, press operators can make minor adjustments before producing out-of-spec parts. When a feature starts trending toward its upper specification limit, quality engineers receive immediate notification to investigate root cause before the process goes out of control.
The system integrates seamlessly with CMMs and vision measurement systems. When parts come off the press and go through automated dimensional inspection, measurement data flows directly into 1factory. Features map to control plans automatically. Out-of-tolerance measurements trigger immediate alerts. Zero manual data transcription means zero transcription errors.
"The biggest issue was operators and technicians that are working with these parts have minimal visibility to just a simple run chart to see where the data was trending. They couldn't see any data beyond the part they were measuring right in front of them. With 1factory, they see SPC data in real-time." — Greg Shoup, CTO, Allegheny Performance Plastics
Material Traceability & Lot Control: Aerospace customers demand complete traceability from raw material lot through finished part serial number. When a resin supplier issues a quality notification, you need to instantly identify which parts were molded from affected material and where those parts shipped. Traditional systems require manually cross-referencing production logs, material receiving records, and shipping documents — a process that can take days.
1factory maintains automatic traceability links. When operators start a production run, they scan the resin lot barcode. The system records which material lot was used for which job, on which press, by which operator, at what date and time. When parts are inspected, that inspection data links to the material lot automatically. When parts ship, the shipping record links to production history.
If a material quality issue arises, quality engineers can query the system: "Show me all parts molded from resin lot XYZ-12345." Within seconds, they have a complete list of affected jobs, part serial numbers, inspection results, and customer shipments. This rapid response capability is essential for aerospace applications where a material defect could have safety-of-flight implications.
Customer Transparency & Deep Collaboration: Aerospace OEMs increasingly demand real-time visibility into supplier quality performance. They want to see SPC data as parts are being produced, not weeks later when reviewing COC packages. Traditional approaches — emailing PDF reports, uploading files to customer portals — create delays and don't provide the transparency aerospace customers expect.
1factory's Deep Collaboration capability changes this relationship entirely. Authorized customer personnel can log into secure portals and view live production data as molding occurs. They see control charts updating in real-time. They can drill down into process capability studies. They can download AS9102 reports, dimensional inspection data, and material certificates instantly.
This transparency builds trust that emails and phone calls cannot match. When aerospace customers can see that Cpk values are consistently above 1.67, that control charts show stable processes, and that every critical dimension is being measured and documented, they gain confidence in supplier capability. This confidence translates to preferred supplier status, sole-source awards, and long-term contracts.
"Allegheny's customers are able to view a live feed of their jobs via 1factory's Deep Collaboration feature, including all SPC and process capability calculations. This level of transparency is unprecedented and has helped build customers' confidence in their capabilities." — Plastics Technology Magazine
AS9100 & ITAR Compliance: Aerospace and defense molders must maintain AS9100 certification and often handle ITAR-controlled technical data. Quality management systems must demonstrate document control, training management, corrective action tracking, and audit readiness. Manual systems with paper-based records make compliance demonstration extremely time-consuming during certification audits.
1factory's QMS provides the systematic approach AS9100 auditors expect. All procedures and work instructions live in a version-controlled repository. When documents are revised, the system automatically notifies affected personnel and tracks who has reviewed changes. Training records link to procedures automatically, showing exactly who has been trained on which processes.
For ITAR compliance, 1factory can be hosted on isolated government-compliant infrastructure. Access controls ensure only authorized personnel can view controlled technical data. Audit trails track who accessed what information and when. During DCAA audits or AS9100 surveillance visits, quality managers can instantly generate compliance reports showing procedure coverage, training status, and document control — dramatically reducing audit preparation time.
First Article Inspection (FAI) & AS9102 Creation: Aerospace customers require AS9102 FAI packages for new parts and part revisions. Creating these packages manually — ballooning drawings, recording measurements, completing Forms 1, 2, and 3 — can take a full day per part. For molders qualifying dozens of new parts during program launches, this becomes overwhelming.
1factory automates the entire FAI workflow. The intelligent ballooning engine reads part drawings, recognizes dimensions and GD&T callouts, and creates inspection plans in minutes. When parts are measured, data populates AS9102 forms automatically. Customer-specific format requirements are handled through templates. What previously took 8 hours now takes 30 minutes.
Return on Investment
Material cost savings justify the software investment in weeks. High-performance polymers costing $75-150 per pound mean a single scrap event can cost thousands of dollars. Real-time SPC prevents these catastrophic failures by catching process drift before significant production occurs. Even preventing one major scrap event per quarter delivers substantial ROI.
Time savings compound across the organization. Manual data transcription is eliminated completely — operators no longer hand-write measurements that quality engineers later type into spreadsheets. SPC chart generation that took hours now happens instantly. Customer data requests that required days of gathering information are answered in minutes through customer portal access.
Quality improvements protect business relationships critical to aerospace molding success. Real-time visibility prevents shipping defective parts to OEM customers. Complete traceability enables rapid response to material quality issues. Demonstrated process capability through live SPC data builds customer confidence that translates to preferred supplier status and long-term program awards.
AS9100 audit preparation time drops from weeks to days. When auditors arrive, quality managers generate compliance reports instantly rather than spending days gathering evidence from scattered sources. This efficiency extends to customer audits where transparent data access demonstrates systematic quality management that manual systems cannot match.
For Medical Device Injection Molding
Companies Like: Precision molders serving Medtronic, Abbott, Boston Scientific, Johnson & Johnson, Stryker, and medical device OEMs requiring FDA compliance, lot traceability, and validation for Class II and Class III device components
Key Challenge: Medical device molders operate under the most stringent regulatory requirements in manufacturing. FDA 21 CFR Part 11 compliance mandates electronic records with complete audit trails, validated systems with documented test protocols, and ironclad traceability from raw material to patient. Device History Records (DHR) must link every component to specific production lots, operators, process parameters, and inspection results. Traditional paper-based systems make this compliance demonstration nearly impossible at scale, while manual record-keeping introduces transcription errors that regulatory audits identify as serious findings. The result is thousands of hours wasted on documentation, failed validation protocols when systems change, and compliance risk that threatens business continuity.
Key Functionality
21 CFR Part 11 Compliance & Electronic Records: FDA's electronic records requirements are non-negotiable for medical device manufacturers. Every quality record must have complete audit trails showing who created it, who approved it, who modified it, and when. Electronic signatures must be as legally binding as handwritten signatures. System validation must demonstrate that the software performs as intended and produces accurate, reliable results.
1factory is purpose-built for 21 CFR Part 11 compliance. Every action in the system generates an audit trail entry — who measured which part, at what time, with what results. When operators complete inspections, they provide electronic signatures that are cryptographically secured and legally binding. When quality engineers approve inspection plans or NCRs, their signatures are captured with full traceability.
The system ships with complete validation packages including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Test scripts demonstrate that the software calculates Cpk correctly, stores data securely, maintains audit trails properly, and enforces access controls appropriately. Quality teams can execute validation protocols in days rather than months, with results that satisfy FDA auditors.
When FDA inspectors arrive, 1factory's audit trails provide the evidence they seek. Every measurement, every approval, every document revision is recorded with timestamp and user identification. Reports can be generated instantly showing who did what and when — dramatically simplifying regulatory compliance demonstration.
Device History Record (DHR) Automation: Medical device manufacturers must maintain complete DHRs for every device or device lot produced. DHRs must include material certifications, process parameters, inspection results, operator identifications, equipment used, and any deviations or nonconformances. Assembling DHRs manually from paper records scattered across production, quality, and materials departments can take days per device.
1factory automates DHR creation by linking all relevant information automatically. When a production lot begins, the system captures which material lots are being used, which press and mold are running, which operators are assigned, and what process parameters are set. As parts are inspected, that inspection data links to the lot automatically. If nonconformances occur, those NCR records link to affected lots.
When customers or regulatory agencies request DHRs, quality engineers simply query the system by lot number or serial number range. Within minutes, complete DHR packages generate automatically, including all required documentation with proper signatures and audit trails. This rapid response capability is essential during FDA inspections or customer quality investigations.
Lot-Specific Traceability & Recall Readiness: Medical device manufacturers must be able to trace every component to specific production lots, material lots, and process conditions. When quality issues arise — whether discovered internally or reported by customers — manufacturers need to instantly identify potentially affected devices and where they shipped.
Traditional systems rely on batch records stored in binders or scattered electronic files. Finding all production lots that used a specific material lot requires manually reviewing hundreds of batch records. Identifying which customers received potentially affected product requires cross-referencing production records with shipping documents. This manual process can take weeks, creating unacceptable delays during recalls or customer notifications.
1factory's automated traceability transforms recall response from weeks to minutes. Material lots link to production lots automatically when operators scan barcode labels. Production lots link to inspection results as measurements are recorded. Shipping records link to production lots when parts ship to customers. All these connections are maintained automatically without manual data entry.
When a traceability query is needed, quality engineers simply enter the reference point — material lot number, production date range, specific out-of-spec measurement — and the system instantly returns all related records. If a material supplier notifies about contamination in lot ABC-123, the system immediately identifies which production lots used that material, whether any quality issues were detected, and which customers received those parts. This rapid response capability can mean the difference between contained issues and regulatory consent decrees.
Statistical Process Control for Process Validation: FDA requires process validation demonstrating that manufacturing processes consistently produce devices meeting predetermined quality attributes. Initial process validation, continued process verification, and revalidation after process changes all require extensive SPC data proving process capability and stability.
1factory streamlines process validation by capturing SPC data automatically from the start of production. Control charts accumulate data across multiple lots, providing the statistical evidence FDA expects. Cpk calculations update continuously as production continues, demonstrating sustained process capability rather than point-in-time snapshots.
When validation reports are due, quality engineers can query the system for specific date ranges or production lots. The system generates comprehensive SPC reports showing control charts, capability studies, and statistical summaries. These reports include all required elements for FDA validation documentation: control limits, process means, standard deviations, Cp/Cpk values, and evidence of statistical control.
For continued process verification required by FDA's 2011 Process Validation Guidance, 1factory maintains ongoing SPC monitoring without additional work. As production continues, the system automatically tracks whether processes remain in statistical control. When control rules are violated, automatic alerts notify quality engineers to investigate before process drift produces nonconforming product.
"Since adopting the software, the company says the biggest savings in time and resources have come from ending manual transposing and navigating multiple systems to retrieve quality information." — Plastics Technology Magazine on Allegheny Performance Plastics
Change Control & Design History File (DHF) Integration: Medical device manufacturers must maintain Design History Files documenting device design, specifications, and validation. When engineering changes occur, change control processes must ensure production implements changes correctly and all affected documentation is updated.
1factory's document control system supports rigorous change management. When part drawings are revised, the system automatically identifies which inspection plans are affected. Quality engineers receive notifications to review and update plans. The system tracks approval workflows, ensuring all required signatures are obtained before revised plans are released to production.
Operators always work from current-revision documents because the system enforces version control automatically. When they scan a part number, the active inspection plan loads — never an obsolete version. This automatic currency prevents the common medical device quality issue of operators using outdated procedures or specifications.
Return on Investment
Validation time savings deliver immediate ROI. Complete validation packages reduce validation project duration from months to weeks. For medical device manufacturers bringing new products to market or implementing system changes, faster validation means faster revenue realization. Even a single month of accelerated time-to-market can justify the software investment entirely.
Regulatory audit preparation transforms from overwhelming to manageable. What previously required weeks of gathering evidence from disparate sources now takes days of report generation. During FDA inspections, the ability to instantly demonstrate compliance with 21 CFR Part 11, produce complete DHRs, and show systematic process control impresses inspectors and reduces inspection findings.
Recall response capability provides insurance against catastrophic business impact. The ability to respond to traceability queries in minutes rather than weeks can mean the difference between contained field actions and consent decrees. For medical device manufacturers, this risk mitigation alone justifies investment in systematic quality management.
Quality improvements protect the most valuable asset medical device manufacturers have: their regulatory approval and customer relationships. Preventing shipping of nonconforming product protects both patient safety and business continuity. Demonstrating robust quality systems through validated, compliant electronic records builds customer confidence that translates to long-term supply agreements and preferred supplier status.
For Automotive Injection Molding
Companies Like: High-volume molders supplying Ford, GM, Stellantis, Toyota, Honda, Volkswagen, and Tier 1 automotive suppliers requiring PPAP, APQP, and statistical process control for interior components, under-hood parts, and safety-critical systems
Key Challenge: Automotive injection molders face relentless pressure on three fronts simultaneously: extreme volume (parts produced in millions), extreme cost pressure (pennies matter), and extreme quality requirements (zero PPM expectations with substantial financial penalties for defects). You're running 24/7 operations across multiple shifts, managing dozens of active programs simultaneously, each with specific PPAP requirements and customer-specific quality demands. Traditional quality systems break down under this complexity. Engineers spend weeks creating PPAP documentation manually. Production data gets batch-uploaded hours or days after parts are molded, making real-time process control impossible. When customers issue Engineering Changes, updating all affected documentation takes days. The result is quality becoming the production bottleneck, missed launch timing costing hundreds of thousands in premium freight, and field failures generating warranty charges that eliminate program profitability.
Key Functionality
PPAP Automation at Scale: Automotive customers require complete Production Part Approval Process (PPAP) packages before production launch. Each PPAP includes 18+ elements: PSW (Part Submission Warrant), dimensional results from initial samples, material test reports, process FMEAs identifying failure modes, control plans defining inspection requirements, MSA studies proving gage capability, and process capability studies demonstrating Cpk ≥ 1.67. Creating these packages manually takes 40+ hours per part. For molders launching 20-30 programs simultaneously, PPAP becomes the bottleneck determining whether launches happen on time or slip with costly delays.
1factory transforms PPAP creation from weeks to hours through systematic automation. Quality engineers start by defining the Process FMEA, identifying potential failure modes and their controls. This FMEA data feeds directly into Control Plan creation — critical characteristics and inspection methods flow from FMEA to Control Plan automatically rather than being retyped manually. Control Plans then generate Inspection Plans automatically, eliminating redundant data entry.
When initial samples are measured, that dimensional data populates PPAP forms automatically. Material test results are attached electronically. Process capability studies generate from inspection data with one click. MSA (Measurement System Analysis) studies can be performed directly in the system with automatic calculation of Gage R&R acceptance criteria. The complete PPAP package assembles automatically, ready for customer submission.
The reusable PPAP library accelerates subsequent programs dramatically. Once quality teams have defined failure modes for an injection molding operation, those can be saved as templates. Standard control methods for critical dimensions become reusable elements. Process flow diagrams for similar parts leverage previous work. This library approach means the 10th PPAP takes a fraction of the time the first PPAP required.
"J&L Manufacturing did not have the manpower to support heavy PPAP documentation requirements and would turn away orders that required PPAPs. With 1factory, J&L was able to drop PPAP creation time from a week to just two hours. J&L completed 168 PPAPs in the first 7 months." — 1factory Case Study
Real-Time SPC for High-Volume Production: Automotive molding runs 24/7 with parts counts in millions annually. Process drift that goes undetected for even a single shift can produce tens of thousands of defective parts before problems are discovered. Traditional SPC approaches — collecting measurements on paper, batch-uploading after shift completion — discover problems only after significant production has occurred.
1factory enables true real-time process control. As operators inspect parts during production, SPC control charts update immediately. Statistical indicators calculate in real-time, triggering automatic alerts the moment data suggests process drift. Process capability (Cp/Cpk) values update continuously, showing current capability rather than outdated numbers from yesterday's data.
Operators see control charts directly at molding presses. When a critical dimension starts trending toward specification limits, they receive immediate visual feedback to make minor process adjustments. When control rules are violated — seven consecutive points above centerline, for example — automatic alerts notify quality engineers and shift supervisors to investigate before drift produces defective parts.
This real-time visibility prevents the automotive molder's nightmare scenario: running an entire weekend shift off-process, then discovering Monday morning that 50,000 parts are scrap. With live SPC, process issues are caught within minutes rather than days, limiting scrap to dozens of parts rather than thousands.
Multi-Cavity Process Control: Automotive molds often run 8, 16, 32, or even 64 cavities simultaneously. Each cavity can perform slightly differently due to mold cooling variations, material flow differences, or mechanical wear. Traditional inspection approaches sample randomly across all cavities, making it impossible to detect cavity-specific issues until significant defects accumulate.
1factory enables cavity-specific SPC tracking. When operators measure parts, they record which cavity produced each part. The system maintains separate control charts for each cavity, revealing performance differences that random sampling would miss. Quality engineers can see that Cavity 12 consistently runs tighter than other cavities, that Cavity 7 is trending toward its upper spec limit, or that Cavity 23 shows increased variation suggesting wear.
This cavity-level visibility enables preventive maintenance rather than reactive firefighting. When cavity-specific control charts show degrading performance, maintenance can address that specific cavity during planned downtime rather than waiting for complete failure during production. For high-volume automotive molding where every hour of unplanned downtime costs thousands in lost production, this predictive capability delivers substantial value.
Engineering Change Management: Automotive programs generate constant engineering changes throughout their lifecycle. A dimensional tolerance tightens. A material specification changes. A critical characteristic is added. Each ECO (Engineering Change Order) requires updating PPAPs, Control Plans, Inspection Plans, work instructions, and operator training. With traditional systems, implementing ECOs can take days or weeks as quality engineers manually update all affected documentation.
1factory streamlines change management through systematic linking. When a part drawing is revised, the system automatically identifies which Control Plans and Inspection Plans reference that part. Quality engineers receive notifications to review affected documents. When Control Plans are updated, those changes flow to Inspection Plans automatically. When Inspection Plans are revised, operators receive notifications about the changes and must acknowledge before resuming production.
This systematic approach compresses ECO implementation from days to hours. More importantly, it prevents the common automotive quality issue of operators working from obsolete procedures because they weren't notified about changes. The system enforces currency automatically — operators always work from current-revision documents.
Customer Portal & Scorecard Management: Automotive OEMs increasingly require supplier scorecards showing real-time quality performance. They want PPM (Parts Per Million) defect rates updated weekly or daily, not quarterly. They expect to see SPC data demonstrating process control, not just summary statistics. They demand rapid response to quality issues with root cause analysis and corrective actions tracked to completion.
1factory's supplier portal provides the transparency automotive customers demand. Authorized customer personnel can log in and view performance metrics in real-time. PPM rates calculate automatically from incoming inspection data. Control charts show current process capability. Customer-specific scorecards update continuously rather than requiring manual data gathering for quarterly business reviews.
When quality issues occur, the SCAR (Supplier Corrective Action Request) workflow in 1factory ensures systematic resolution. Customers can initiate SCARs directly through the portal. Suppliers respond using structured 8D problem-solving methodology. Root cause analysis, containment actions, corrective actions, and effectiveness verification are all tracked in the system. Customers can see SCAR status in real-time rather than waiting for email updates.
This transparency builds the trust that leads to program awards. When automotive customers can see consistent quality performance, systematic problem-solving, and proactive communication, they award additional programs to capable suppliers. For automotive molders, preferred supplier status with major OEMs is worth millions in annual revenue.
Return on Investment
PPAP productivity improvements deliver immediate financial impact. Reducing PPAP creation time from 40 hours to 8 hours means quality engineers can support 5X more program launches with the same headcount. For automotive molders landing multiple new programs simultaneously, this productivity determines whether launches happen on time or slip with costly delays. Even preventing one program delay can justify the software investment through avoided premium freight and customer penalties.
Scrap prevention in high-volume production generates massive savings. Automotive molding typically operates on 3-5% margins, meaning scrap rates directly determine profitability. Real-time SPC that catches process drift within minutes rather than hours can reduce scrap rates from 2% to 0.5%. On annual production volumes of 10 million parts at $0.50 material cost, reducing scrap by 1.5% saves $75,000 annually — per part number.
Field failure prevention protects the most valuable asset automotive suppliers have: their quality reputation and customer relationships. A single field campaign can cost millions in warranty charges and permanently damage customer scorecards. Systematic quality management that prevents shipping defective parts to customers protects both immediate profitability and long-term business viability.
Quality team productivity improvements compound across the organization. Engineers spend less time creating PPAPs and more time on value-added process improvement. Quality technicians spend less time transcribing data and more time analyzing trends. Managers spend less time generating scorecards and more time developing their teams. These productivity gains let quality departments support more programs without proportionally adding headcount — critical for automotive suppliers operating under constant cost-down pressure.