Revision: 04/11/2011
(Edited notes 12 and 13 and made changes to the process flowchart to eliminate the Discrepant Material Report (DMR); and replaced it with the Non Conformance Report (NCR))
PRODUCTION PROCESS OVERVIEW NOTES:
1. When a Job Traveler is issued to the shop, a copy of drawings or part specific specifications are provided with the Job Traveler. These documents serve as the information describing product characteristics and the work instructions. Process specific work instructions may also exist and would be maintained at the process when it is believed such detail is needed (only when on-the-job-training [OJT] to the applicable Position Guideline (accessed through the Organization Chart) is not considered enough information).
2. CRITERIA:
•Does the Job Traveler show a PO number for material already ordered (may be written)?
•Material in stock?
•Customer-supplied?
3. If the item is received is a secured item (noted as such on the container or by the method of sign-off required at receipt) follow the practices outlined in Standard Practice Procedures (security) while fulfilling the applicable section of the controls listed below. At a minimum, receiving inspection is verifying the item received is not damaged. This is the same whether the item is material or supplies, product returning from an outsourced process, equipment, or customer property. Additional receiving inspection requirements are as follows:
•Material, supplies, and equipment - Verify packing slip matches what was received, packing slip matches the purchase order (PO), and receive in Vista. The record of inspection is the signed or initialed copy of the PO or packing slip, which includes the evidence of conformity (we received what we ordered [this would include all material certifications such as Heat treatment and Chemical and Mechanical Properties certs]) and the name (signature or initials) of the person authorizing release (person saying it is okay to use).
•Product returning from an outsourced process - Verify packing slip matches what was received, required certs or test reports were provided, and receive in Vista and submit to Quality. Quality completes receiving inspection by verifying the outsourced activity was done (which may include a review of certs or test reports) and parts are to print (see 8.1 Statistical Techniques Related To Production & Service Provision in this document). Quality signs off the applicable step on the Job Traveler as the record of this inspection (outsourced process noted on the Job Traveler having been completed is the evidence of conformity and the sign off [name or initials] authorizes release).
•Customer owned property (material or equipment) - When a packing slip is provided, the material received is verified against the packing slip. Consideration is also given to whether or not we can actually use the material (in a condition we can and are willing to use in our equipment). The Customer Owned Property Log facilitates this process, serving as the record of this type of receiving inspection and for reporting and recording of any loss, damage, or unsuitability issues.
•Customer return - Notify management of the return and await their disposition. If the return is not clearly identified as nonconforming product, tag or label the item so it is clearly understood (preventing unintended use).
If nonconformance is encountered, the person having made the purchase is notified and disposition is as is defined in the Nonconforming Product Procedure (embedded in this document).
4. Material may be pulled by management or person performing task. If certs or test reports are required (for all medical devices and/or those jobs where traceability is noted on the Traveler) the material used will have certs or test reports. The Cert, Test Report, or PO number used to purchase the material is noted or attached to the Job Traveler.
5. So long as the job is not a secured part, previous programs (we have made the part before) may be stored on the network (controlled as defined in Document & Records Control). We may also maintain it on a floppy disk (if secured, maintained as defined in Standard Practice Procedures (security), with the controls outlined in Document & Records Control also governing our actions to ensure we are using the correct version.
6. CRITERIA:
•Specialized monitoring or measuring devices (CMM, squareness gauge, air gauges, etc.) needed to verify dimensions?
•Operator or management feel the need to get someone else to get involved in verifying the set-up is good to go?
7. CRITERIA:
•Matches requirements outlined in the print for the step involved?
Record of inspection is the signed off Job Traveler.
8. The machine operator monitors the process by checking the critical dimensions (.003" or less), capable of being checked with a hand held calibrated device (see Statistical Techniques Related To Product & Service Provision in this document to understand the size sample we pull for these monitoring & measurement activities). Management may also choose to define requirements for monitoring using the Process Monitoring form. For the most part, problems encountered would be corrected by making adjustments as needed (changing feeds and speeds, tooling, etc.). When the problem encountered is more serious (e.g... a significant amount of product [large quantity or dollar value] is scrapped or is in need of rework or repair; or, the issue at hand should be addressed to prevent a serious problem from happening), the improvement opportunity is handled as defined in the Improvement Systems process. Evidence of this "monitoring of the process" is the machine operator signing off the step on the Job Traveler upon completion.
9. CRITERIA:
•Matches requirements outlined in the print for the step involved?
•Presentation worthy finish (no obvious scratches, dings, nicks, finish is not rough and/or does not show chip imprints)?
•Certs or test reports show outsourced process is per requirements (when inspection is for product returned from outsourced process)?
Record of inspection is the signed off Job Traveler. Quality Assurance will complete inspection sheets with recorded results of dimensional and characteristic measurements; as the customer requires and/or as standards stipulate. These measurements are recorded on forms and inspection reports. These records include in-process inspections: the Inspct_in_Process_Datasheet; and, finished product inspection such as the Final_Datasheet form. Requirements for receiving inspection of outsourced processes is also addressed in note 3.
10. Complete FAI form (may be included in the Job Traveler), completing customer FAI per their requirements, when applicable.
11. Having verified all the required steps (including inspections and/or tests, the customer's purchase order is pulled for shipping instructions (including the address, carrier, any freight billing instructions, etc.). Packaging per customer requirements (may be in PO, drawing, or specification), when provided. When no requirements are given, general packaging guidelines are geared towards surviving the method of shipping. Hand delivered direct is wrapped or packed to protect part from damage. Hand delivered to receiving is packed as if it were a freight shipment. Freight is packed in boxes with approximately 1 inch clearance on all sides and layered to protect from part to part contact. Label Turnco Name and address, customer name, address, PO #, part number, revision, & quantity. If going to stock, may be packed or may be stored in bins. Identify with labels noting do not stack, fragile, etc., as needed. Delivered items (including those the customer picks up) are signed for on the packing list. Tracking numbers for items shipped are noted on or attached to the packing list. If the item is secured, it has to be double boxed. The outside box will have all edges taped and only includes the shipper name and address and the receiver's name and address. The internal box also needs all edges taped and each side must be stamped with the appropriate classification, (secret, top secret, etc.). The internal box needs to include the shipper's name and address and the receiver's name, address, and person the package is to be directed to, as applicable. Secured item delivery or shipment is as described in Standard Practice Procedures (security).
12. When the reworked item involves any form of machining or production, it is re-inspected (evidenced by the signed off step on the Job Traveler and the Non Conformance Report [NCR] signed off by Quality). The re-inspection uses the same methods for the normal inspection (see notes and process flow related to notes 6, 7 & 9). When the reworked item is a purchased item, it is returned to receiving or to management so it can be recognized as stock; or, issued to a job. If a customer return is reworked, it is processed with the aid of a Job Traveler and the NCR.
13. This nonconforming product procedure ensures product not conforming to requirements is identified. It will be marked or tagged in some intuitively obvious manner so as to prevent it being mistaken for acceptable product. Managers are consulted to allow for their determination of when and if the full NCR process is followed. In some cases, where the customer is giving us a repeat order with extra materials for set-up or first piece allowances; managers may choose to not start the NCR process. They can use discretion and choose to scrap the part and move on w/o an NCR because of a prior agreement and understanding from the customer that they've given us extra material or allowances knowing that there is a possibility of scrap or fallout. These customers also agree to purchase plus/minus a few pieces because they've allowed the job to start with more materials and also understand there are possibilities of no scrap or fallout. Management also has the freedom and authority to invoke the full NCR process. Under management direction, in these cases, after the part has been initially identified or tagged, It would be noted as nonconforming on the NCR maintained with the product, noted on the Job Traveler, tagged or labeled as rejected, nonconforming or some other intuitively obvious means noting the product is nonconforming, and/or would be placed in a segregated area. Disposition (described throughout the processes) is for the most part left up to the person identifying the nonconformance (unless stated differently in the process shown), with management called upon as needed (large quantity, dollar amount, process says they need to be involved, etc.). Records of the nature of nonconformities (what is wrong) and the actions taken, including any concessions obtained exist in the NCR (when it happened in production) or on the OI-Log -or- the Opportunities & Incidents Log (when it involves something purchased or a customer return). If it is believed and/or can be proven product was used or shipped before we figured out it was nonconforming (parts at the next step in our process, in stock, already at the customer, etc.), management is notified and facilitates action to deal with the situation (rounds up all suspect product, calls the customer to let them know when they are affected, etc.) If the nonconformance related to a medical device involves a supplier, the supplier is informed and is part of the resolution (including any corrective action involved). Should the situation warrant notification of the customer and the FDA concerning product safety, an advisory notice would be submitted.
7.5.5 Preservation of Product (including 7.5.4 - customer property)
Identification - Secured items are identified as described in Security. Other forms of preservation related identification include "fragile", "do not stack", or other such labels or markings intended to help the product survive to the point of use. Where the need is based upon requirements, it is included in the drawing or in customer or industry standards. When this is not the case, the need is based upon the experience of those packing the product or on customer feedback. Included information to ensure identification of this type is accomplished would be included in the Job Traveler or process-specific instructions when it is not considered to be intuitively obvious.
Handling - Typically, common sense governs our product handling. Any special handling requirements (we impose or imposed by the customer [including customer property], such as, wearing gloves) are noted on the Job Traveler or included in the customer's documentation provided with the Job Traveler or maintained in the area.Generic handling rules include such things as:
•maintaining order of the product to ensure materials are not mixed from one customer to another,
•taking care when loading or unloading parts into a machine or when transporting forklift or other moving equipment, and
•avoiding over-stacking of parts or containers to avoid crushing the containers or damaging the parts.
Packaging -Any special packaging requirements (we impose or imposed by the customer [including customer property]) are noted on the Job Traveleror work instruction specific to the product. General packaging rules include such things as:
•stacking product on a pallet so there is nothing hanging over the edges, when feasible,
•limiting the number of items per container to maintain a manageable weight,
•using sufficient bubble pack/styrofoam to protect the product from damage, and
•limiting the number of items per container to maintain its integrity during shipping.
Storage - See the Storage Areas Table included in this document, with secured storage addressed in Security.
Protection - For the most part, protection includes storage in areas that prevent damage to the product (i.e., indoor and climate controlled material storage, when needed) but may involve the need for heightened security (see Security) or confidentiality (i.e., noting proprietary on drawing where the customer identifies the need to do so). Materials which have limited life (i.e., glues, epoxy, etc.) are used in a manner to prevent use of expired product (first-in-first-out [FIFO]) and are labeled to allow the user to make sure we are still in the date range prior to use.
If Customer Owned Equipment or Material is Lost, Damaged, or Found to be Unsuitable For Use - Whether we made it that way or we found it to be lost, damaged, or unsuitable for use, notify management of the incident so they can follow the reporting and recording requirements outlined in the Customer Owned Property Log.
Storage Areas Table 7.5.5
Storage Scenarios / Receipt Into / Dispatch FromReceiving (all receiving areas) / Packing list, Vista, or Customer Owned Property Log / Provided to requester as needed or noted
Staging / Job Traveler notes the next step needed Issued to area fulfilling / Job Traveler
Production Area / Job Traveler / Steps on Job Traveler
Outsourcing / Job TravelerPO / Step signed off on Job TravelerPO received
Stock (Finished Goods) / Add to Parts in Stock spreadsheet & placed in stock / Removed from Parts in Stock
Shipping / Completed Job Traveler or pulled Parts in Stock / Packing Slip
7.5.1d & 7.6 Related To Selection & Use Of Such Devices
When a device is used for monitoring or measurement of a product or process, we make sure it is capable of an accurate measurement and is used correctly. Correct use is based upon training provided (see the Position Guideline accessed through the Organization Chart). Selection is ensuring the device is capable of accurately measuring in the specified range or accurately demonstrating required specifications are being met. The other important thing to recognize is the need to report damaged devices or those not reading accurately to Quality. This will allow us to resolve any problem/potential problem.
7.5.3 Identification, Status, and Traceability
What it is (identification), what is its state of existence (status), and where did it come from/where did it go (traceability)?
IDENTIFICATION (including 7.5.4 - customer property):
•Raw Material - Material type or a part number noted on or attached to the item(s). May also be based on storage location labeled to reflect what the item being stored are.
•Work-In-Process (WIP) - Typically, this is intuitively obvious as the material can be related back to the order using the Traveler. When this is not the case, tagging or labeling maybe used.
•Finished Goods - Identified by label(s) on the container, shipping label, and/or Bill of Lading (BOL).
STATUS:
•Raw Material - Based upon location (i.e., inventory locations [also see Storage Areas Table]), and/or the material's its physical condition (i.e., bars, sheets, etc.).
•WIP - Derived from the combination of the Job Traveler (found with the material) and physical location.
•Finished Goods - Typically, based upon location, but may also be statused by the shipping label and/or BOL.
TRACEABILITY:
•Non-medical device product - Traceability for non-medical device parts tends to be forward traceability (relating material or processing certs or test reports with the material or the product it was used on or the processing was done to), with the record being the PO number noted on the Job Traveler or by maintaining the certs or test reports with the job. If and when additional traceability requirements are acknowledged, Planning For Success will be used to implement those controls, including any records to be maintained.
•Medical device product - Traceability is maintained through the Device History Record (which is all of the pertinent information for the job, including component and material traceability and is maintained with the Job Traveler).
8.1 Statistical Techniques Related To Product & Service Provision
Turnco Tool uses this sampling method to inspect, monitor and measure its product and processes for conformance to customer requirements.
The typical sampling method in use at TurnCo Tool is as follows (See Sample Plan), unless otherwise specified by the Customer. {Note: Customer specific plans are specified by their quality standards (QA team) and are either named/described on their PO or may be sent with the PO via email or in some written format. When sent separately from the PO, the customers' sampling plans are saved and controlled on the network "X" drive.} Management communicates the need for a specified customer plan for a given P.O. / Job order to the affected personnel. When a sampling plan is not specified by the Customer or requested by management, Turnco Tool will use the plan described below (See Sample Plan).