Nonconformance Procedure Original Release Date: Revision Level: 05-03-2016 C Revision Date: 01-18-2018 SpecSys Inc. Granite Falls, MN New Ulm, MN Watertown, SD Prentice, WI 1 of 7
Nonconformance Procedure 1.0 Purpose The purpose of this procedure is to define a systemic approach for identifying, documenting, containing, and evaluating nonconforming product. 2.0 Scope To control all nonconforming product, equipment, process or condition by ensuring that all nonconformance s are identified and corrected in a formalized and controlled manner. This procedure applies to all SpecSys, Inc. personnel in the manufacturing setting where they observe situations that do not meet the minimum requirements of the applicable print, standard, code or specification. This procedure is to provide the framework for: Alert, notice or recognition of a nonconformance Documenting nonconformance Ensuring corrective action is administered to prevent recurrence or contain a known defect Follow up and close out of the NCR (Nonconformance Report) 3.0 Responsibilities It is the responsibility of: Any SpecSys, Inc. employee to notify their immediate superior in the event a deficient condition has been identified. The Lead Person, Supervisor, Manager, or appointed personnel to dutifully initiate a formal NCR whenever the deficient condition is deemed nonconforming. The Plant Manager / Quality Department / Project Management to review the NCR, determine the course of action by defining the rework or containment instructions via going through the correct channels for disposition. Quality Department / Plant Manager / Project Manager to oversee the action(s) administered for all nonconformance issues, ensure follow up is completed, and the NCR is closed out. 4.0 Identification of a Nonconforming Condition The majority of the nonconforming conditions will be identified during the manufacturing process. However, any employee may identify a nonconformance situation during their normal working activities. A nonconformance condition identified: Within the department s processes (mid-work, pre-closed quality checks, etc.) when the nonconformance is easily repairable and does not require assistance from other departments, an NCR is not required. I.e. Weld department finds the weld department s nonconformance prior to leaving weld. o Discovered inside of department, but unclear how to move forward, an NCR is needed. Outside the department responsible for the nonconformance, must have a formal NCR generated according to the requirements in Section 5 of this procedure. o Rule of Labor Prudence: If rework for the nonconformance will take less than six minutes to completion of rework an NCR is not warranted (if found outside of the department that caused it). Greater than six minutes of rework requires an NCR. 2 of 7
5.0 Nonconformance Report (NCR) Documentation The Nonconformance Report (NCR) is a multi-copy form (QA-20) consisting of a white and yellow copy for distribution and resolution, and a hard-card red copy (red tag) to attach to the part for rejection identification. All parts deemed nonconforming must be identified using an NCR with the following information in the Identification section: Part Number Print Number and/or Item Number of the product found to be nonconforming. Description Of the part number(s) as described on the print. Date NCR was generated. Qty Quantity found to be nonconforming. WO Number Work Order Number assigned by SpecSys, Inc. Facility/Supplier SpecSys Manufacturing Facility or Supplier who manufactured or supplied the nonconforming product. Description of Nonconformance Give a brief description as to the reason the product does not meet the applicable requirement(s). When writing the description of the nonconformance, always begin the statement by associating to the print feature that is nonconforming, i.e.: o The 5.250 in. dimension is 4.250. o ½ fillet weld for Item #3 measures ¼. o 2.375 +/-0.010 Dia. Bore measures 2.355. The person who fills out the nonconformance shall write his/her Name and enter the appropriate Date. ** Any employee capable of filling out the NCR form can do so. The department s Lead should be made aware of the NCR if they are not directly involved in identifying the issue and filling out the NCR ** 6.0 Nonconformance Report (NCR) Red Tagging and NCR Delivery: Upon completion of the Identification section of the form, the originator will: Remove the red tag from the back of the form and attach it to the nonconforming product using a tag wire. Isolate the product(s) apart from usable product until final disposition has been determined. Provide the NCR for disposition using option 1 if available, or otherwise option 2: 1. Deliver the white and yellow copy of the NCR to the applicable Plant Manager, Quality Employee, or Project Manager (whichever is physically on-site). 2. If Plant Manager, Quality Employee and Project Manager are not present on site, scan and email the NCR to the Quality Department (quality@ritalka.com) Note: All completed NCR s (white, yellow and red copy) must be provided to the quality department via physical hand-off, interoffice mail or email to quality@ritalka.com for final closure. 3 of 7
7.0 Plant Manager / Quality Department / Project Manager will review the nonconformance and direct the NCR through the appropriate channels. The individual that develops the disposition will complete the Disposition and Rework Instructions sections and write their name and the date in the Rework Instructions section (write all on White copy and rip off Yellow copy). Then for: Rework o The Plant Manager, Quality Employee, or Project Manager will notify the appropriate Lead Person to complete the rework as noted on the NCR. When physically in the same location they will deliver the Yellow copy to the Lead that has the rework instructions on it. When not on location the instructions will be emailed appropriately. It is the Lead s responsibility to verify that the rework was performed and found to be acceptable, fill out and sign/date the Description of Corrective / Preventive Actions section on the Yellow copy, and return it to the Plant Manager, Quality, or Project Manager. Plant Manager, Quality, or Project Manager will verify the work and take the red tag to be submitted with the closed NCR documents. Plant Manager, Quality, or Project Manager will then sign and date the Approved By section on the White copy. Once the Quality Department has all of the forms back and work has been completed they will sign and date the Nonconformance Closure section Note: The Plant Manager or Project Manager is responsible for forwarding the White and Yellow copy NCR and red tag to the Quality Department for final close out if it is them that gathered the documents. Use-As-Is o Check the appropriate box. o Sign and date in the Approved By space provided. o Notify the applicable department Lead. The Plant Manager or Project Manager is responsible for getting the NCR to the Quality Department for close out if it is them that disposition it. Scrap o The Plant Manager, Quality member, or Project Manager will notify the appropriate Lead Person to scrap as noted on the NCR. o The Lead must notify the one who dispositioned the NCR when completed. The one who dispositions the NCR is responsible for providing the NCR to the Quality Department for close out. Inventory will need to be adjusted in GSS. Procurement actions to follow as needed. Customer Deviation Request o Contact the appropriate client rep pertaining to the situation. o If approved check the appropriate box. o Sign and date in the Approved By space provided. 4 of 7
Approved : attach a copy of the customer s acceptance to the NCR and provide to the Quality Department. Disapproved : attach a copy of the customer s disapproval, document the Work Order Number for part replacement and forward to the Project Manager so they can initiate the steps forward that they deem appropriate. If the deviation request results in an accepted rework plan, follow Rework instructions above. The Project Manager must be notified of the deviation request results. 8.0 Supply Chain Manager / Purchasing Agent will review the nonconformance when the course of action is noted as Return to Supplier. It is the responsibility of the Supply Chain Manager and/or Purchasing Agent to notify the applicable supplier of the deficiency and agree on a course of action to: Return To Supplier o Check the appropriate box. o Sign and date in the Approved By space provided. o Document the RMA #, replacement PO Number, or returned credit agreement in the Description of Corrective/Preventive Action section. o Forward completed NCR documents to the Quality Department for closure Rework at SpecSys: o Check the appropriate box. o Documented rework instructions from the supplier must be attached to the NCR. o Sign and date in the Rework Instructions space provided. o Provide to Plant Manager / Quality / Project Manager who will then follow the Rework protocol laid out above. Scrap at SpecSys: o Notify Plant Manager / Quality / Project Manager who will then follow Scrap protocol listed above. Inventory will need to be adjusted in GSS. The NCR documents are provided to the Quality Department for close out. **Appendix A: Flowchart on next page** 5 of 7
Appendix A: NCR Flowchart 6 of 7
DATE REVISION CHANGES APPROVAL 5-03-2016 A Initial Release Doug Schrader 9-15-2016 B Added Flowchart & SpecSys locations Pam Schmid 1-18-2018 C Revised verbiage & flowchart Riley Wald 7 of 7