ISO Q&A

                                            

            

As Lewis Yasenchak wraps up his 2016 Keeping Up with ISO column this month, he has a few more  items to share that we were unable to fit on the pages of MMT. I decided we'll serve up his additional insight in some upcoming blogs. Below is a recommended business assessment form you can use to determine where you stand with ISO 9001 certification.

 

Within section 4.0 of the ISO 9001: 2015 revised standard, companies must answer the following questions as they relate to the company by responding: No, Have nothing in place or not planned, No, Planned, but not yet documented, Yes, developed, but not fully documented or implemented or Yes, documented and fully implemented.   

Organization & Philosophy

• Has a Quality Policy been developed?
• Is the policy communicated to all employees?                                               
• Are responsibilities and authorities defined?                                      
• Are scheduled system reviews performed?                                         
• Are records of these meetings kept?                            

Quality System

• Are documented policies and procedures available?                                      
• Are they effectively implemented?                                         
• Are procedures formally structured?                                      
• Do procedures get distributed throughout the organization?                          
• Are policies and procedures controlled?                                             

Contract Review

• Do you review customer requirements?                                              
• Have these reviews been effective?                                         

Design Control

• Have design and development activities responsibilities been established?
• Have written procedures been developed for design control describing methods for specification review, design review, drafting checks, functional reviews between disciplines, skill adequacy of personnel, design controls on outside sources, reporting to top management on effectiveness?       
• Does the final design documentation include acceptance/rejection criteria, regulatory requirements or safety or functional characteristics?                                        
• Are designs changes properly documented and reviewed?                                        

Document Control

• Are all procedures followed?                                     
• Are all changes to documentation reviewed by designated personne?
• Does a system exist for issuing, recall and revision of documents?
• Are all disciplines involved in the review process?                            
• Has a method to control customer supplied documents been established?
• Do inspection or test procedures get updated based on engineering or specification changes?
• Are obsolete drawings or documents removed from use?                              
• Has a “Master List” or equivalent document been created to identify the current revision of documents?

Purchasing

• Is there a list of approved suppliers (subcontractors) ?                                              
• Is there a procedure outlining the approval criteria?                                      
• Are supplier audits performed?                                              
• Is supplier performance monitored?                                       
• Do you have a supplier rating program?                                             
• Is there a Certification program in place?                                          
• Do procedures allow for use of suppliers test records as verification
• Are suppliers given specifications, drawings, pertinent process requirements, approval requirements, engineering changes and deviations?                                               

Purchaser Supplied Product

• Are procedures in place to control customer supplied product?

Product Identification and Traceability

• Do you have lot traceability on materials produced?                                                  
• Are records maintained?                                             

Process Control

• Are work instructions used?                                       
• Do instructions have accept/reject criteria?                                        
• Do instructions detail how to handle nonconforming material?
• When required, do you have procedures to address special processes?

Inspection and Testing

• Is the quality of incoming materials checked?                                               
• Are there documented inspection instructions?                                              
• Is there a procedure for the use of non-verified material?                                          
• Do inspection instructions indicate types of equipment to use?                                             
• Is a final or dock audit performed?                                        
• Are records of these inspections and audits maintained?                                            

Inspection, Measuring and Test Equipment

• Are all gages and test equipment calibrated?                                     
• Is equipment identified with calibration due dates?                                       
• Are gages calibrated under controlled conditions?                                        
• Is the certification for masters current?                                              
• Are repeatability & reproducibility studies performed?                                             

Inspection and Test Status

• Do you identify the status raw materials, in-process materials, finished materials and inspections?

Control of Nonconforming Product

• Is there a controlled area designated for nonconforming products?
• When nonconforming products are identified, are they moved to the designated area?
• Are nonconforming products identified as such?                                            

• Do reports exist that identify discrepant materials and their status?
• Is there an analysis performed?                                              
• Are repaired or reworked products re-inspected?                                           

Corrective Action with risk levels (high, moderate, low)  

• Are there procedures established for:
  • Investigating the cause of non-conformances and corrective action needed to prevent recurrence?
  • Analyzing all process, work operations, records and customer complaints to detect and eliminate potential causes of non-conformances?
  • Initiating preventive actions to deal with problems?                                      
  • Applying controls to ensure that corrective actions are taken and effective?  
  • Implementing and recording changes to procedures resulting from corrective actions?

Handling, Storage, Packaging, & Delivery

• Do you maintain material integrity during storage and handling?
• Is inventory readily identifiable?                                             
• Is there a “First-in, First-Out” stock rotation plan in use?                                         
• Are material storage areas restricted?                                                 
• Are there procedures to identify packaging, shipping and labeling requirements?
• Are shipping records maintained?                                           

Quality Records

• Are records maintained and available?                                               
• Have record retention times been established?                                               
• Are storage areas environmentally controlled?                                              

Internal Audits

• Are internal systems audits scheduled and performed?                                              
• Are results documented?                                            

Training

• Has a training program for employees been established?                                           
• Is training given on a regular basis?                                        
• Do you maintain records of employee training?                                             

Servicing

• When specified by contract, has a procedure been established to verify servicing requirements are met?

Statistical Techniques

• Are statistical techniques currently used?                                          
• Are records maintained and reviewed?                                              

Quality Costs

• Are quality costs tracked and reported?                                              
• How often and to whom are these reports given?                                           

Reliability Testing

• Does life testing on products take place?                                            
• Are reliability prediction methods utilized?                                        
• Does a plan exist for reporting these test results?                                           

Housekeeping

• Do you have a policy in place outlining the type of work environment to maintain?

Quality Plans

• Are quality plans used in the manufacturing process?          

Human Resources

• Does this organization use team concepts and employee involvement for quality? improvements?

Benchmarking

• Do you utilize benchmarking as a means of quality improvement?