TEI Company Information

Transcription

1 The following Case Scenario is provided to this workshop in order to train IAQG Certified 3 rd party auditors on the changes that are implemented with the AS9101E audit standard. The objective of this workshop is to provide auditors with this Case Scenario information and review the audited objective evidence, nonconforming issues, where this information will be recorded on the new Audit Report forms, and finally, what process effectiveness level would be assigned by you for the PEAR report documented for the Product Realization process - Purchasing. For this workshop, you the 3 rd party auditor working for a CB called ARU will be auditing Triple Engineering, Incorporated (TEI). This audit is a 12 month surveillance audit. The audit plan you have submitted to TEI documents that you will be auditing the TEI Management, Internal Audit and Purchasing processes. TEI Company Information TEI is a medium-sized manufacturing company that is certified to ISO9001:2008 & AS9100C standards by ARU - a 3 rd party IAQG accredited certification body. TEI manufactures complex high value integrated structures for their customers. In order for TEI to produce their products to a controlled work schedule, the Production Control department identifies and schedules the build demand for each build-up work station within the MRP system. The MRP system maintains the BOM that provides the Purchasing Department with the daily need-to-buy list. The need-to-buy list identifies the various part numbers, quantities for each build, and need by dates required to meet upcoming build schedule demands. All detail parts and subassemblies are purchased from TEI s approved supplier s that are included on the TEI Approved Supplier Report which is controlled by both the Inspection and Purchasing Departments. Products purchased include the following commodities Machined Housings, Metering Valves/Sleeves, Motors, Pumps, Wire Harnesses, and Fasteners. The Inspection process completes final inspection and acceptance of each purchased product before they are released to the production department to begin the Production/Build process. Audit of Management Process You begin the interview process with the TEI Director of Operations. The interview includes discussions on how he and the senior management team at TEI support the QMS and what are the plans and goals to continually improve the company s overall performance. The Director explains that they have established objectives that will closely monitor the company s performance throughout each and every process of the company. He further explains that the company holds an annual Management Review Meeting that he mandates all management staff is in attendance. He informs you that this meeting reviews the company s performance metrics as well as the customer complaints, changes to the QMS that become necessary, improvements to the company/qms, etc. so that they can keep a finger on the pulse of their organization. At this point in the discussion you comment that the audit preplanning data provided to ARU shows performance metrics below expectations and ask the Director if he is aware of this and what actions his team at TEI are implementing to improve performance. He replies that there are actions being taken and advises the audit guides to make sure that the plans are offered to you to review during the course of the audit. The Director does not provide a good explanation for the below goal performance for key metrics or even appear to know that the company is not meeting the goals for the key metrics. Your response is that you will follow up and review the company s actions to address process performance during this audit and will focus on the metrics and actions implemented if any during the review of the

2 management review portion of the audit. You end the interview with the Director and proceed to the conference room to review the Quality Manual/procedures. Quality Manual, QM0001, revision date November 2, 2013, revision 3 is reviewed. You review the manual for revisions that have been completed since the previous ARU audit and determine that they are acceptable and approved by TEI management. You then proceed to review the TEI 2013 and 2014 Management Review Reporting. The reporting includes a standardized template that covers the ISO9001:2008/AS9100C mandatory inputs for management review reporting with the exception that TEI s Customer Service Group did not document the customer complaints that were sent to them from two TEI customer s - Standard Aircraft Company (SAC) and Arrow Aircraft Company (AAC). The complaint information was documented along with the ARU audit preplanning form by the TEI contact. In addition, the Standard Aircraft Company had sent an OASIS feedback to ARU registrars six months prior to this surveillance audit to notify them that TEI was not meeting promised delivery dates and this in turn was causing SAC from shipping to their customers on time. You proceed to ask the TEI Quality Manager about the missing complaint information and he replies that sometimes these sorts of issues are not included in the Management Review Reporting. He further states to you that senior management does not like to air their dirty laundry during this type of meeting so they have asked that the Quality Manager withhold this type of information from the reporting. He continues to comment that the management is aware of these complaints and they will eventually be taken care of by the Customer Service group. This ends the audit of the management process. Audit of Internal Audit Process You have completed the review of TEI approved Internal Auditing procedure #IA-101. You begin to interview the Internal Audit Manager on the remainder of the activities associated with the process. He informs you that the internal audit group is made up of 4 full time internal auditors and 4 guest/trainee auditors that are on 2 year development rotation assignment. Per procedure IA-101, all auditors are to be trained by going to IAQG accredited auditor training. You reviewed the training records for all 8 auditors and have found 7 of the 8 auditors have completed and passed their accredited training. The 8th auditor did not have any evidence of training. The Audit Manager indicated that this auditor is on rotation and had only been in the group for 3 months. Procedure #IA-101 states that all new auditors have 6 months after accepting the audit assignment to obtain and pass the required training. Evidence provided indicated that the new auditor was scheduled in 2 weeks to attend the accredited training course. You now change the interview from the audit personnel to the process for scheduling the audits and how the annual audit plan is determined, communicated and managed. The audit manager responded that the annual schedule is based on risk. At the end of the 4th quarter of each year, the auditor group holds a week long planning session along with the Audit Manager in order to review performance data available within the company, previous audit results and trends, and set up interviews with Executive Leaders to gain feedback from them about their concerns, issues with their operations. All this information is reviewed and areas of risk are prioritized with audit frequencies defined. You are presented with a copy of the 2014 audit schedule and there are several departments that were or will be audited to a special frequency due to the identified risks. Once the audit schedule is developed, it is presented to the senior management team for final approval and communicated to all managers within the company through the system. Your review of the 2014 schedule confirms that all audits are being conducted on schedule. You sample 3 audit report packages IA 002, IA 005, and IA 010 and determine that the reporting is

3 satisfactory. All required records per the internal audit procedure were in order. All Corrective actions were completed on schedule and closed out. You request to see the corrective action process which is managed by the TEI CAR Database. The database has the capability to provide notifications to the corrective action owner when corrective action due dates are approaching. The database also includes an escalation notification process when CAR responses and closures remain overdue. This system is quite an improvement from previous methods of tracking CARs since it has reduced delinquencies by 80% since it was implemented 2 years ago. All delinquent corrective actions are re-assigned ownership from the process owner to the department leader. End of the Internal Audit process audit. Audit of Purchasing Process The Purchasing audit begins by asking questions relating to the Purchasing process in order to determine a high-level view of the process activities and performance. You take notes about the Purchasing process map included within the Quality Manual: The process also includes interactions with other departments and their processes, including Contracts, MRP Control and Finance. TEI, Case Study / PEAR Scenario 1 Your initial observations from TEI s management reporting for the most recent reporting period included the following performance achieved against the established KPI/goals: Supplier on-time delivery June 2013: Target 95%, Actual = 98% Supplier right the first time June 2013: Target 98%, Actual = 82% These measures are described by the organization as their two key Purchasing process performance indicators and are tracked on a monthly basis. Your review for previous reporting periods reveals that delivery performance routinely meets the goal of 95%, Actuals: May 99%, April 98%, March January 100%. Next you review the reporting for previous months for the Supplier right the first time metric and determine that the 98% minimum goal is not being realized. The KPI report shows the following months performance: May 79%, March - April 83%, February 72% and January 88% and upon further interview with the Purchasing Department Manager he states that he is not aware of any improvement plans being established by senior management or his department staff to correct the lower than desired performance. TEI Case Study / PEAR Scenario 2

4 Your review for previous reporting periods reveals that delivery performance routinely meets the goal of 95%, Actuals May 99%, April 98%, March January -100%. The same is not the case when reviewing the performance ratings for previous months for the Supplier right the first time Actual May 79%, March - April 83%, February 72% and January 88%. During the interview you ask the Purchasing Manager if he and or Senior Management are aware of the poor performance against this KPI by their approved suppliers and he responds that the CEO, CFO and he are well aware of the problem. He then hands you a documented management review report and shows you where this KPI was discussed in length concerning the poor supplier product quality performance and shows you what the company has assigned as action items to address these issues. The actions include several improvement plans that include: 1. The development of a supplier improvement group to evaluate each underperforming supplier and the development of corrective action plans established to help them improve on product quality. 2. The improvement team has established a Supplier Improvement Meeting Room where underperforming suppliers are required to visit the TEI facility with their management team to present their actions taken or to be taken to address their poor performance on product quality. To date, you review records that document that 3 meetings have already been completed. 3. The supplier improvement group has also mandated that the suppliers provide updates against their actions plans on a weekly basis while the team continues to evaluate their product quality performance. 4. Each supplier was notified that until their performance improves to the 98% goal their business activity with TEI has been placed on a limited approval status which requires all future purchases with this supplier to be reviewed and approved by TEI senior management and the supplier improvement group. Failure of these suppliers to demonstrate a steady improvement will initiate actions to remove them from the TEI Approved Supplier List - ASL. Case Study Final Information ( Info. Documented below applies to both Pear Scenarios) The Purchasing audit then follows a trail into the supplier control process whereby you sample four purchase orders 10154, 10155, 10162, and Each of the purchase orders appear to be welldocumented and to accurately describe the product to be purchased. However, when comparing the purchase orders and suppliers that received the orders against the TEI ASL, you see that one supplier (The Casting Company) is not included on the ASL. You proceed to inquire if you can review the last evaluation report pertaining to The Casting Company ; the report was promptly retrieved from their record system database. The report appeared to be well-written and contained two action items that have been addressed and closed. Subsequently, the evaluation result was deemed to be positive and the supplier was approved. Upon further questioning, the missing ASL entry appears to be an administrative oversight for not updating the ASL as required when new suppliers are approved. You then follow another audit trail to examine the MRP system that is updated by receiving personnel when goods are received into the organisation. You request to review a sample of five recent

5 Receiving Documents referenced from within the MRP system (#R12456, R32290, R65574, R23349, and R22957). The Receiving Documents are verified by the receiving inspection inspectors along with the supplier s Certificate of Conformance whereby the inspector s place their acceptance stamp and date on each document once accepted. Hard copies of the documents are scanned into the TEI database and then filed in secure storage cabinets. All COCs except one could be located at the time of the audit without explanation; however a replacement facsimile copy was obtained and presented as evidence later in the day. END OF CASE STUDY Color Code Table: Yellow Caution, audit trail may lead to nonconformance Blue Objective evidence Red Nonconforming NCR required.