24338 Road 148 / N/A
Oakwood Ohio 45873
SCOPE OF REGISTRATION
Manufacturing of precision machined components to customer specification.
STANDARD APPLIED / ACTIVITY CATEGORY
X / ISO 9001-2000 / DOC REVIEW / SURVEILLANCE
PRE-ASSESSMENT / X / REASSESSMENT
ASSESSMENT / SPECIAL VISIT
TRANSFER OF REGISTRATION
TEAM LEAD or LEAD AUDITOR / OTHER TEAM MEMBERS
Warren R. Blazy Jr.
ACTIVITY CONCLUSIONS (check all that apply)
yes / CONFORMING / 0 / NUMBER of MINORS RAISED
0 / NUMBER of OBSERVATIONS or OPPORTUNITIES FOR IMPROVEMENT IDENTIFIED
yes / REGISTRATION RECOMMENDED / CONTINUED REGISTRATION RECOMMENDED
no / CORRECTIVE ACTION SUBMITTAL REQUIRED / 0 / WORKING DAYS (from report date)
no / ON-SITE REVIEW OF CORRECTIVE ACTION REQUIRED
0 / NONCONFORMING WITH MAJOR NONCONFORMANCES / 0 / NUMBER of MAJORS RAISED
n/a / REGISTRATION NOT RECOMMENDED
no / SPECIAL VISIT REQUIRED / n/a / DURATION (audit days required)
SPECIAL COMMENTS
LEAD AUDITOR / COMPANY REPRESENTATIVE
Warren R. Blazy Jr.
- Signature on this report by the assessed Company Representative indicates that this report, and any nonconformities and observations noted within, has been reviewed and accepted.
- Any nonconformities or observations identified are the result of a limited sampling process.
- The Internal Audit system is deemed effective unless noted otherwise within this report.
- This report remains under established confidentiality agreements between NQA and the assessed organization.
- Prior to the initial assessment, the organization must have performed a full system internal audit, followed by a documented management review. The quality management system must be understood throughout the organization.
ISO 9001 ASSESSMENT MATRIX AND PLANNER
ISO 9001 REQUIREMENTS / LEGENDX = Element Fully Assessed
P = Partial Element Assessed
E = Exclusions Taken
* = Audit each Activity / MANAGEMENT ACTIVITIES / RESOURCE MANAGEMENT / PRODUCT REALIZATION PLANNING / PRODUCT REALIZATION / DESIGN & DEVELOPMENT / REASSESSMENT ACTIVITY
4.2.1 / DOCUMENTATION GENERAL / X / X
4.2.2 / QUALITY MANUAL* / X / X / X / X / X / X
4.2.3 / CONTROL OF DOCUMENTS / X / X
4.2.4 / CONTROL OF RECORDS / X / X
5.1 / MANAGEMENT COMMITMENT / X / X
5.2 / CUSTOMER FOCUS / X / X
5.3 / QUALITY POLICY / X / X
5.4.1 / QUALITY OBJECTIVES* / X / X / X / X / X / X
5.4.2 / QMS PLANNING / X / X
5.5.1 / RESPONSIBILITY & AUTHORITY / X / X
5.5.2 / MANAGEMENT REPRESENTATIVE / X / X
5.5.3 / INTERNAL COMMUNICATION / X / X
5.6 / MANAGEMENT REVIEW* / X / X / X / X / X / X
6.1 / PROVISION OF RESOURCES / X / X
6.2.1 / HUMAN RESOURCES GENERAL / X / X
6.2.2 / COMPETENCE, AWARENESS & TRAINING / X / X
6.3 / INFRASTRUCTURE / X / X
6.4 / WORK ENVIRONMENT / X / X
7.1 / PLANNING PRODUCT REALIZATION / X / X
7.2.1 / DETERMINATION OF REQUIREMENTS / X / X
7.2.2 / REVIEW OF PRODUCT REQUIREMENTS / X / X
7.2.3 / CUSTOMER COMMUNICATION / X / X
7.3 / DESIGN & DEVELOPMENT / N/A / N/A / N/A / N/A / N/A / N/A
7.4.1 / PURCHASING PROCESS / X / X
7.4.2 / PURCHASING INFORMATION / X
7.4.3 / VERIFICATION OF PURCHASED PRODUCT / X
7.5.1 / CONTROL OF PROVISION / X / X
7.5.2 / VALIDATION OF PROCESSES / X / X
7.5.3 / IDENTIFICATION & TRACEABILITY / X / X
7.5.4 / CUSTOMER PROPERTY / X / X
7.5.5 / PRESERVATION OF PRODUCT / X / X
7.6 / MONITORING & MEASUREMENT DEVICES / X / X
8.1 / MEASUREMENT, ANALYSIS & IMPROVEMENT / X / X
8.2.1 / CUSTOMER SATISFACTION* / X / X / X / X / X / X
8.2.2 / INTERNAL AUDIT* / X / X / X / X / X / X
8.2.3 / PROCESS MONITORING/MEASUREMENT / X / X
8.2.4 / PRODUCT MONITORING/MEASUREMENT / X / X
8.3 / CONTROL NONCONFORMING PRODUCT / X / X
8.4 / ANALYSIS OF DATA* / X / X / X / X / X / X
8.5.1 / CONTINUAL IMPROVEMENT* / X / X / X / X / X / X
8.5.2 / CORRECTIVE ACTION* / X / X / X / X / X / X
8.5.3 / PREVENTIVE ACTION* / X / X / X / X / X / X
USE OF MARKS* / X / X / X / X / X / X
CURRENT SECTIONS COVERED (SURVEILLANCE NUMBER)
FUTURE SURVEILLANCE PLANNING / NEXT YEAR / 11/2008 / 5/ 2009 / 11/2009 / 5/2010 / 11/2010 / 5/2011
FOLLOWING YEAR
AUDIT ACTIVITY RECORD
Audit trail reviewed / Personnel interviewed / Documentation reviewed / Departments or Processes AuditedObjective evidence sampled
INTERVIEWED:Dave Maxey ISO Management Rep. Chuck Behrens Vice President. Brian Bauer President. Brian Miller Controller. 16 hourly employees.
DOCUMENTS REVIEWED: Process Map QM-4.1 dated 4/11/05. Quality Policy dated 10/26/04. Organizational Chart dated 2/12/08. Quality Manual revision history log. Table of Content dated 11/21/06. Level II manual. Scope of the Company QM-Scope dated 5/27/05. Plant forms Manual Table of contents dated 4/28/08. Internal Quality Audit Worksheet Form #IA2 dated 10/29/04. Non-Conformance Report Form IA4 10/29/04. DMDR Form rev00. RMCI Individual Primary Process Control Plan Form QSF 9.3-001 Form rev 11/12/04. Inspection Sample Record SF1006 rev 1. Certificate of Conformance 4-Forms/QSF-9/4-002 doc. Aeroquip Process Control Plan QA05 3/17/06. Shop Traveler Form LR-001 8/2/05. Shipment Schedule Form SS-001 10/14/03. Mills Setup File History Log Form #PR5 11/3/04.End of shift Form PR7 4/3/06. Castings Pulled From Inventory report Form 8.2_4 3/28/08. Safety Cabinet Inventory Re-Order Form. SSI-F003 11/11/04. Employee Job Performance Review Form HR-1150 10/25/06. QSP 8.2.1 8/24/07. QSP 8.4.2 5/19/06 QSP 7.4 11/17/04. QSP 8.2.2 11/23/04 QM Scope 3/2/04. QM 4.2 3/2/05. Master list of records QSP 4.2.4 11/21/06. Control of Documents QSP 4.2.3 5/25/05. System metrics Form MR-02a 11/23/05. Plant Scrap form MR-03 11/23/05.Scrap by month Form. Scrap % by month form. Sales $ lost by month. Total parts produced form. Perishable tool usage. Department 100 efficiency form. Department 200 efficiency form. Hold for inspection matrix for 2008.
OBJECTIVE EVIDENCE SAMPLED:
Robert manufacturing takes and justifies exclusions to 7.3 Design and Development, 7.5.1 Control of Production and Service Provision. 7.5.2 Validation of Processes for Production and Service Provision.
Audited 4.2.2 Quality manual. The quality manual is review annual by the management rep and a copy of the sign off is posted in the level I quality manual. The last review of the quality was conducted and signs off on 1/4/08 by Dave Maxey. Quality policy was found and reviewed in the level I Quality Manual. Organizational Chart was found to be in order in the level I manual. Table of Content was reviewed and found to be in order. QM-Scope is clearly stated in both the level I and level II manuals. Roberts Manufacturing has three different levels of quality manuals. Level I The quality manual stating the quality policy of the company. The quality manual is the highest authority in the quality management system. The Level 1 policies control all other levels of documentation. Level II The quality system producers’ manual is the second level of documentation and contains the quality system operating procedures. Level II describes how the quality system functions. Level 3 Task-Specific operating procedures, quality plans and work instructions that provide detailed instructions on how the task is performed. Level 4 are all the forms and records used by Roberts Manufacturing. Sample Obsolete records to verify that all dates matched the new producers according to the level I manual and all were found to be in order at the time of this audit. All areas of 4.2.2 Quality Manual were audited and all were found to be in order at the time of this audit. No findings were noted.
AREAS OF GOOD PERFORMANCE
Management Commitment. Roberts is one of the best ISO systems that I audit. One of the main reasons for this is due to the commitment that management has made to the continual success of the ISO program. A solid system is in place and management commitment plays a huge role in there success.
AREAS FOR IMPROVEMENT
AUDIT ACTIVITY RECORD
Audit trail Reviewed / Personnel Interviewed / Documentation Reviewed / Departments or Processes AuditedObjective Evidence Sampled
Audited 4.2.4 Control of Records. A master list of records is located in the Level II Manual. Records were established and maintained according to the requirements of the ISO 9001 2000 standards. All records were found to be legible, readily identifiable and were retrievable at the time of this audit. QSP-4.2.4 Control of Records clearly spells out the controls needed for the identification, storage, protection, retrieval, retention time and disposition of all records. All areas were found to be in order at the time of this audit with no finding being noted. Samples of records were pulled and checked during this audit.
Audited 5.3 Quality Policy. There are 14 locations through out the plant with the quality policy. The Quality Policy is reviewed and studied at every Management review meeting and is also talked about at the quarterly review meetings. The quality policy is also audited with internal audits and is pasted down the chain with one on one communication from upper management to the supervisors down to the newest person. The quality policy is also talked about during orientation with new employees as part of the information that new employees receive when they are hired in to Roberts Manufacturing. All areas were audited and all were found to be in order. No findings were noted at the time of this audit.
Audited 4.2.3 Control of Documents. Documents are controlled in two different ways. The master documents are controlled by Dave Maxey and are kept in his office. When Dave is not in his office the office is locked. All other documents are control with a red stamp (black stamp if the document is copied). This matches the procedures that are in place at Roberts. Read only is open to all employees however accesses to the electrical version to make changes to any documents is limited to the management rep and a few top managers. Any and all changes that are made, the M/R is notified and he must approve the final changes before the procedures can move on. This is in accordance to the procedure in place in the level II Manual. All areas were audited and all found to be in order at the time of this audit. No findings were noted at the time of this audit.
Audited 5.4 PlanningMost of the planning process is passed down to the VP of Operations. He then according to the procedures in place assigns areas of responsibility to fulfill the requirements of the customer. Customer visits are conducted to determine the needs of the customer and then follow up is conducted on one of the top managers to ensure that all areas are being addressed. Areas that are looked at in planning are current and future needs of the company and industry. Relevant findings from Management Review. Product and process performance. Levels of satisfaction, internal and external. Assessment results. Competitor analysis bench marking new opportunities for improvement. Continually sourcing new resources needed to fulfill quality objects. Very strong area. Check takes a great deal of pride to ensure that the customer is satisfied and planning plays a huge role in ensures that customer continue to purchase and bring in new business to Roberts Manufacturing. All areas were addressed at the time of this audit and all were found to be in order. No findings were noted.
Audited 8.2.1 Customer satisfaction. Roberts uses customer visits, customer complaints and feedback, surveys, trip reports, e-mail phone calls, score cards from customer, web sites from the customer are graded on customer web sites, deliver reports and other measurements as a means of measuring customer satisfaction. All areas were addressed and all found to be in order. No findings were noted at the time of this audit.
AREAS OF GOOD PERFORMANCE
AREAS FOR IMPROVEMENT
Audit trail Reviewed / Personnel Interviewed / Documentation Reviewed / Departments or Processes Audited
Objective Evidence Sampled
Audited 5.6 Management Review. The last management review meeting was held on April 23 2008. According to Robert requirements, M/R meetings are held usually once per month.
Records of the management review meetings were check and found to be in order. Attendance sheets are sign at each meeting with the President, Vice President, Comptroller and all senior management personnel present when available. The Management rep is the one that conducts the meetings. All areas of input and output. Are addressed at each and every meeting. Another areas that are addressed in this meeting is safety and employee suggestions. All areas of management review were audited and all were found to be in order at the time of this audit Roberts has very strong and solid management review meetings with the information being pulled and used to help with the growth of the company. No findings were noted at the time of this audit.
Audited 8.4 Analysis of Data. Roberts uses data to measure the success of the company. The data that is pulled is not only in depth, but easy to read and trend. So examples of data that is measured at Roberts is Monthly Quality Objectives, Plant Scrap, 2006 virus 2007 scrap report, sales by month, total parts produced, delivery reports, on time delivery reports, percent defective parts, late supplier shipment tracking report, Supplier DMDR tracking report, perishable tool usage, department 100 efficiency, department 200 efficiency, and hold for inspection matrix. Excellent use of data. Very strong area. All areas audited with no findings being noted.
7.1 Planning of product realization. Audited all areas of Planning 7.1 The Vice President of the company does all the Planning and realization. All areas were audited and all found to be in order at the time of this audit. No findings were noted at the time of the audit.
Audited 7.2.1 Determination of requirements All areas were audited and found to be in order. No findings were noted at the time of this audit.
7.2.2. Review Requirements all areas audited and all found to be in order at the time of the audit. No findings were noted.
Audited 5.2 Customer Focus. The president ensures that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction. I was a le to witness this first hand during the audit. A new customer with new requirements has join Roberts. The customer focus because the most important role of the day with the President, Vice President and all the management staff reviewing all the needs for this new customer. A” to be determined” list was written up by the VP of Operation and at this meeting all were given the task of making sure that the areas of responsibility that they were given were addressed and all concerns were taken care of. Dave Maxey was given the role of following up on all the action. This is a very good example of how Roberts ensures customer focus. All areas were addressed during this audit and all were found to be in order at the time of the audit with no findings being noted.
AREAS OF GOOD PERFORMANCE
AREAS FOR IMPROVEMENT
Audit trail Reviewed / Personnel Interviewed / Documentation Reviewed / Departments or Processes Audited
Objective Evidence Sampled
Audited 5.1 Management Commitment. The president of the company provided me evidence of his commitment to the development and implementation of the quality system. His commitment included, quality policy, quarterly communication meetings, one on one meetings and informal meetings with supervisors about there work areas. Measurable including data are also used to help with management communication. Management review meetings are another tool that the president uses to the commitment of management. Financial measurements of where the company is and where it wants to be. Roberts has a very good and solid management and the commitment was reflected throughout the plant both with the hourly and salary employees. The employees are asked to use the suggestion forms to communicate the needs and wants of the employees to help with the growth of the company. All areas were audited and all found to be in order at the time of this audit. No findings were noted.
Audited 5.5.2 Management Representative. The president gives total support to the M/r both with time resources. The management rep will report to the President or the VP of Operation to make sure that the message is getting to those that need to hear it. Dave has the title of M/R and Quality Manager, but is given the time and support needed to make sure that the ISO system is working well and growing. The information board in the cafeteria is another why that the message of top management is shared with all the employees.
Audited 7.2.3 Customer Communication. A customer corrective action team is used to help with customer communication. When a new customer or a new part is being established a blue print of the part is asked for by Roberts. The entire requirement including size and material is listed. The amount of parts that need to be produced are also asked for. Once it is agreed that the part can be produced. A price is then agreed on and all spec’s are agreed on. Once an order is placed first article is sent for approval. Roberts will conform to whatever the customer is asking for. From that point on the router will reflect the information off the new part worksheet and then the router reflects the spec’s on the next order. For standard parts the router stays in the system and anytime the order is called for the router will be pulled and the same information is placed on it. If something changes and part needs to be modified then the above takes place. All areas of customer communication was looked at and all was found to be in order
AREAS OF GOOD PERFORMANCE
AREAS FOR IMPROVEMENT
Audit trail Reviewed / Personnel Interviewed / Documentation Reviewed / Departments or Processes Audited
Objective Evidence Sampled
Audited 7.6 Control of Monitoring and Measuring. Roberts has one trained employee that is in charge of all the calibration in the plant. This employee has a computer system that flags him whenever anything is closing in on the due date for calibration. Check records and found all the calibration record to be on time and in order. I check 18 calibrated tools and looked at the dates of calibration and the next due date. All 18 tools were calibrated on time and again records confirmed my findings. This is a very good system that Roberts has in place. All other areas of monitoring and measuring were audited and all were found to be in good working order. His is a very good system and Roberts has done a very good job in this and many other areas. No findings were noted at the time of this audit.
Audited 8.3 Control of nonconforming Product. A tag system is in place at Roberts for all nonconforming products. Procedures are in place and followed for any product that is place on hold. The product is evaluated to determine if it can be reworked or scrapped. If the product is to be reworked, it is placed back into the system and the tag follows the product until it has be rechecked and released. Once the product is released the tag is turned into QA and recorded (4.2.4). If the product is to be scrapped, the product is remove for the work areas and is place into a scrap bin. The scrap bin is out of the main working area and the tag is then removed and recorded by QA and the scarp product is removed for not only the work area but the computer pulls the product out of inventory. I followed this procedure during this audit to verify that the procedures were being followed and that was the case during this audit. All scrap product was account for and all was recorded according to set procedures. Once again, this is just one of many areas that Robert excels in when it comes to there ISO system and one that is followed day in and day out. All areas were addressed during this audit and all were found to be in order at the time of this audit. No findings were noted.