8.1 Operational Planning and Control
a. Plan how to meet requirements, control operations, and ensure quality.
Bill of Materials Importer pulls drawings into Fulcrum and builds routings, so engineering requirements flow from Quote to Job.
Specifications, drawings, and safety notes are attached on Items and Jobs and shown on the shop floor interface: Job Tracking.
Document acceptance criteria and required resources, and capture review / approval of the production plan.
b-1. Set criteria for the processes.
Routings hold estimated setup and run times and required work centers; the AutoSchedule plans them.
Job Tracking shows work instructions including drawings on the shop floor.
Routing steps contain Job notes for communicating the established process and intended results.
b-2. Set criteria for acceptance of products & services.
Quality Checkpoints let you define inspection frequency, method, and tolerance; the results are recorded against the job.
Non-Conformance Report workflow flags Jobs or Lots that fail.
c. Determine resources to meet requirements and on-time delivery.
Backlog shows what machines have the most work scheduled that may become bottlenecks.
Estimated Production Completion Dates calculated by the Autoschedule gives Sales a simple way to commit delivery dates to customers.
d. Control the processes per the criteria.
Operators clock in and out of each operation. Job Tracking updates status in real time and enforces the defined routing steps.
e-1 & e-2. Keep documented information: prove the process and the product.
Every action is date- and user-stamped in Audit Logs.
Certs roll up automatically from material lots to jobs.
Sign-off/close-out of operations provide proof of the process.
f. Manage critical items & key characteristics.
Flag key characteristics in Quality Checkpoints for operators.
Use dashboards to monitor scrap or out-of-tolerance trends.
g. Engage representatives of affected functions in planning & control.
Live dashboards and role-based access put the same plan in front of Sales, Production, and Quality.
@mentions in Chat keep teams aligned and communicating on the same information.
Capture meeting minutes or approvals proving Sales, Production, Quality, and other affected functions reviewed and agreed to the plan.
h. Plan resources for product use & maintenance.
Define and document required resources, tools, and instructions for product use, servicing, and long-term maintenance.
i. Identify externally-provided products & services.
Outside Process Steps are built into the BOM & Routing and Buy items are tracked.
Outside Processing Planning helps coordinate external service providers.
j. Prevent non-conforming output from reaching the customer.
In-process inspections, final sign-off, and approval from a responsible party are supported in Fulcrum. Jobs with NCRs are flagged for review.
8.1.1 Operational Risk Management
Assign owners, set criteria, spot and mitigate shop floor risks, accept residual risk.
Autoschedule flags late or capacity-constrained jobs in real time, letting planners run instant what-if scenarios and re-sequence work.
Backlog highlights bottlenecks and unused hours by department.
Non-Conformance dashboard surfaces recurring defects that raise risk.
Document planning for potential pitfalls.
8.1.2 Configuration Management
Control identity/revision and keep documents in sync with the physical product throughout the life-cycle.
Revisions update everywhere you choose (Sales Orders, Jobs, Items). Job Tracking auto-refreshes when updates are made so operators always see the latest spec and files.
File Attachments (drawings, spec sheets) ride along with every Job ensuring one-click access to the right version.
Plan and control processes to assure safety across the life-cycle (hazard analysis, critical items, event reporting, training).
Job-specific work instructions can include material-handling guidance, and NCR / CAR workflows let users log and track safety-related events.
Document basic practices for maintaining product safety, often through onboarding and yearly training.
Plan and control to keep suspect parts out of delivered product.
Attach supplier certificates to each received lot; certificates flow automatically to any job that uses the material.
Score vendors on on-time delivery and defect rate; set status to Approved, Probation, Monitor, or Disqualify.
Trace any material so if there’s suspect of counterfeit, all impact can be found and contained easily.
Run a counterfeit-parts detection program: qualify suppliers, verify material, quarantine and report suspects, keep trace records.
8.2.1 Customer Communication
Provide information, manage enquiries/orders/changes, capture feedback and complaints, protect customer property, plan contingencies.
Sales Orders show the status of all Jobs associated with an order.
Sales Orders record any changes and revisions for audit.
File Attachments let you log and return customer-supplied property (i.e., fixtures, drawings).
Create NCRs for customer complaints.
Customer Portal allows customers to see the live progress of an order.
Establish and document a customer-communication procedure for enquiries, order changes, complaints, property control, and contingency contacts.
8.2.2 Determine Requirements
Define all product, statutory, regulatory, and special requirements before starting work. Ensure claims are realistic and identify operational risks.
Estimated Production Completion Dates represent realistic lead times for Sales teams to communicate to customers.
Use documentation like a contract-review checklist to verify all statutory, regulatory, and special requirements before committing.
8.2.3 Review Requirements
Conduct a contract review before accepting work and retain evidence of the review.
Quote approval workflow plus Estimated Production Completion Date and Backlog assists contract review before accepting the quote.
Audit Log keeps a time-stamped record of each quote revision and approval.
Keep signed evidence that contract review, capability checks, and discrepancy resolutions happened before accepting the order.
8.2.4 Requirements Changes
Update records and notify relevant parties when customer requirements change.
When there's an item revision or a job changes, Autoschedule refreshes and operators see the new revision the next time they open Job Tracking.
Chat gives you a quick and easy way to communicate and flag any changes.
8.3.1 Design & Development
Maintain an appropriate design process.
Write procedures so critical know-how is captured, controlled, and available to all employees.
8.3.2 Design & Development Planning
Plan design stages, reviews, validation, resource planning, and customer input.
Fulcrum can record engineering labor time and lock jobs before release.
Create a design plan that sets stages, resources, customer input, review gates, and release approvals.
Choose and manage vendors to reduce risk and ensure quality. Keep proof of evaluation and re-evaluation.
Approved vendor lists and Vendor Quality Scores help mitigate the risk of repeat supplier issues.
Qualify suppliers, monitor performance, re-evaluate regularly, and keep approval evidence.
Control production to make sure products meet defined quality standards.
8.5.1 Controlled Conditions
a. Documented info that defines product characteristics and results.
Job Tracking auto-pulls item revisions, routings, specs, and drawing attachments — always showing the current version to operators.
b. Suitable monitoring and measuring resources available.
Provide infrastructure for measurement and testing equipment.
c. Implement monitoring and measurement at the right stages.
Quality Checkpoints on each routing step capture inspection data and acceptance criteria.
Document and provide in-process and article measurement requirements across the organization.
d. Using the right tools for the job.
Keep evidence through things like a preventive-maintenance log, fixture ID tags, software-version list, housekeeping audit.
e. Assign competent persons and qualifications.
Show evidence through things like a training matrix, weld or inspection qualification cards, signed competency tests.
f. Validate and re-validate processes whose output isn’t fully verifiable (special processes).
Show evidence through things like a special-process validation report, periodic re-validation records, approval certificates, and test certificates.
g. Actions to prevent human error.
QR scanning in Job Tracker enforces correct part and operation before clock-in.
h. Control release, delivery, post-delivery.
Set final inspection sign-off and shipment tracking.
Sales Order generation/tracking, refund lines, and pack slip generation keep orders in line.
i. Establish criteria for workmanship.
Notes are tied to routing steps and added as work instructions to define the criteria for the job.
Include helpful items like photos, sample boards, or written workmanship guides at each station. During onboarding new employees, set initial expectations.
j. Maintain accountability for all product (quantity splits, and scrap).
Real-time WIP quantity tracking is live throughout Fulcrum.
Non-Conformance workflow records scrap and splits.
Part counting, including warnings for over/under production help operators produce the right number of parts.
k. Control and monitor critical items and key characteristics.
Flag key-characteristic features inside in-process checkpoints.
Out-of-tolerance measurements are auto-flagged for operators.
Show proof of up-front analysis and documented rationale that turns “this looks important” into a formally controlled critical item with key characteristics.
l. Define methods to measure viable data.
Document inspection work instruction, list of gauges or on-machine probing steps.
m. Identify in-process inspection points.
Routing steps can be set to Inspection so Autoschedule pauses until passed.
n. Evidence all operations completed as planned.
Time-stamped Audit Log of every clock-in/out and checkpoint result.
Warnings and flags stop operators from continuing routing steps without checkpoints getting sign-off.
o. Prevent, detect, and remove foreign objects.
In-process checkpoints or routing steps prompt your team to perform a foreign object detection sweep.
p. Control utilities & supplies affecting the product.
Compile compressed-air test results, coolant-concentration log, chemical shelf-life chart, etc.
q. Identify parts released pending test so they can be recalled.
Lot traceability links every finished part to material and certs so lots can be quarantined later if needed.
8.5.1.1 Control of Equipment, Tools, Software Programs
Make sure equipment and software used in production is validated and fit for use.
Collect proof through program release record, fixture inspection tag, calibration certificates, tooling-maintenance log. Or document and perform equipment validation plans for validate tool reliability and reproducibility.
8.5.1.2 Validation & Control of Special Processes
Establish requirements for outside processes.
Re-validate suppliers and their process capabilities on a documented regular basis.
8.5.1.3 Production Process Verification
Conduct First Article Inspections or similar checks to confirm output. Retain documented information of results.
First Article Inspection in-process checkpoint set verification, and In-Process tracking (IPT) Reports are downloadable from the Job.
8.5.2 Identification & Traceability
Track products through production and identify them clearly.
Job or Item Labels can be printed to identify work.
Show status vs. monitoring and measurement throughout production.
Operation status from Job Tracking is visible live.
In-process checkpoints record pass/fail or measured values at each step.
Control acceptance-authority media.
Operator log-ins serve as the electronic signature for each checkpoint.
Role-based permissions restrict who can sign off.
Unique identification and retained records for traceability.
Lot tracking links raw material batches to finished parts.
Certifications rollup to all relevant Jobs.
For shops that serialize parts, Fulcrum covers some but not all use cases. The concept of serialization that Fulcrum doesn't yet support is the idea of tracking a unique ID against 100% identical products that are produced in a continuous run.
Handle customer-supplied property.
Identify items as customer-supplied.
Create NCRs for any issues.
This clause also expects physical protection, verification, status checks, and disposition records.
Preserve parts through ID, handling, packaging, storage, and transport.
Work Instructions help to aid in special handling and you can store supplied documents as attachments.
Custom Labels help identify jobs with special handling needs.
Show evidence of Foreign Object Debris (FOD) program/audit.
Plan how you’ll support the customer after the product is delivered.
Sales Order tracking, Pack List generation and tracking, Package labels with instructions for use, refund/return on lines help post-delivery.
Stored production data is easily searchable for customer communication.
NCR and CAPA reporting from customer complaints helps understand previous issues.
Define and outline your process for warranty, service, recall, and continued monitoring when required by contract or risk.
Retain proof of changes made, including who made the changes when, and what actions were taken.
Audit logs track every change in the system.
Keep a document tracking changes affecting processes, production equipment, tools, or software programs, etc. as determined important by the organization.
8.6 Release of Products and Services
Show proof of conformance and who approved it before shipping to customer.
Final Inspection routing step with time-stamped approval of an authorized user helps keep track of steps before release.
Logged user information for who preformed any operation closure keeps an audit trail.
8.7.1 Control of Nonconforming Outputs
Identify and choose the resulting action of any nonconformity.
NCR creation and CAPA reports can be created from Job Tracking or the Quality section in Fulcrum.
Decide what to do with nonconforming parts.
Track scrap and set jobs as rework.
