Understanding The ISO/TS 16949:2002 Standard

4    QUALITY MANAGEMENT SYSTEM

4.1 General Requirements  

Establish, document, implement and maintain your QMS and continually improve its effectiveness in accordance with the requirements of this standard. Your organization shall: 

a)    Identify the processes needed for your QMS and also identify where they are applied throughout your organization. 

b)    Determine the sequence and interaction of your QMS processes. 

c)    Determine the criteria and methods needed to ensure both the effective operation and control of these processes 

d)    Ensure resources and information are available to support the operation and monitoring of all QMS processes  

e)    Monitor, measure, and analyze your QMS processes 

f)    Implement actions to achieve planned results and continually improve your processes 

Manage your QMS processes in accordance with the requirements of this Standard 

Control any outsourced processes that affect product conformity to requirements & identify such processes within your QMS 

Note: Your QMS processes should include processes for management activities, provision of resources, product realization, and measurement as part of QMS

4.1.1: Supplemental – outsourcing of processes does not absolve your company of responsibility to conform to customer requirements. (see clause 7.4.1; 7.4.1.3; 7.3.6.2; 7.5.1.5). 

Key Explanation Points and Tips: 

Þ      The primary focus of clause 4.1 requirements is to manage and control all your QMS processes including product realization processes. The note under clause 4.1 requires that your QMS must also include processes for management activities, provision of resources, product realization, and measurement as part of QMS.  

Þ      Clause 4.1 requires the ‘Process Approach’ to be used in defining your QMS. Review section 0.2 Process Approach of this document for a good understanding of clause 4.1 requirements and how they may be applied. 

Þ      Documentation of QMS processes and the need for and detail of specific process documentation is determined by – ISO 9001; customer; regulatory and your own organizational requirements. Other factors to consider may include - complexity of products and processes; effect on quality; risk of customer dissatisfaction; economic risk; effectiveness and efficiency; competence of personnel. Clause 4.2.1d requires you to have documents needed to ensure the effective planning, operation and control for QMS processes.  

Þ      Based on these factors, you must determine what processes need to be documented and how you will document it.  Not all identified QMS processes need to be documented; however your quality manual must include a description of the interaction between your QMS processes. 

Þ      A number of different methods can be used to document processes (each with varying degrees of detail), such as graphical representations, written instructions, spreadsheets, checklists, flow charts, visual media, or electronic methods, etc. Process flowcharts or block diagrams can show how policies, objectives, influential factors, job functions, activities, material, equipment, resources, information, people and decision making interact and/or interrelate in a logical order. 

Þ      Procedures may be an acceptable way to document processes provided they describe details of inputs and outputs, appropriate responsibilities, controls and resources; and process performance indicators needed to satisfy customer requirements. 

Þ      Regardless of whether or not you document all of your processes, you must provide evidence of effective implementation of all your QMS processes. Such evidence does not necessarily need to be documented and may be demonstrated. 

Þ      Clause 4.1c requires you to determine criteria for effective process operation and control. Specific criteria may be needed to control inputs, outputs and resources used. 

Þ      For example - raw materials as an input to production would have acceptance criteria that it must meet before it can be used; finished product as an output of the production process must meet acceptance criteria before it can be shipped to the customer; the equipment used to transform raw materials into finished product may have set-up and capability criteria or parameters that it must meet in order to produce conforming product. These prevention based criteria (controls) must be established for each QMS process. Note that such controls may also come from the customer, regulatory or industry bodies. 

Þ      Equally important are the specific methods (clause 4.1c) required for effective operation and control of each process. These may include job travelers; work instructions; in process inspection sheet; specifications and drawings; SPC charts; set up checklist; machine manuals; etc. Note these control methods may apply to any or all of process inputs, outputs or conversion activities. 

Þ      Under 4.1d - resources for QMS processes may include – facility, material; equipment; labor; supplies; utilities; etc. Every QMS process will require a different combination of resources. Resource details may be identified in specifications; production schedules; bill of materials; production travelers or routers, work instructions, etc. The planning of resources will be determined in MOP’s (clause 5) and provision and control of resources will be determined by SOP’s (clause 6). 

Þ      Clause 4.1d- information for QMS processes will vary from process to process and may include – production schedules; bill of materials; product acceptance and process performance criteria; production traveler or router; work instructions; etc. Use clause 4.2.3 and other relevant clauses to control process information. 

Þ      Clause 4.1e requires you to monitor and measure your QMS processes. Clause 8 provides requirements to plan and implement these controls for monitoring and measuring conformity to process performance criteria determined in 4.1c above. Measurement and monitoring processes may include – tracking against process parameters, goals and objectives, using tools and records such as process check-sheets; product acceptance criteria; SPC records; production records; maintenance records; labor records, etc. More details on monitoring and measuring controls are covered in clause 8. QMP’s typically perform this function (see section 0.2 Process Approach of this document). 

Þ      Clause 4.1e - Analysis of QMS processes may be done through a review of measurement and monitoring records and performance indicators. These reviews must identify opportunities to improve QMS processes, use of resources and product quality. See clauses 8.2.3 and 8.4 for more insight on process monitoring, measurement and analysis. 

Þ      Under clause 4.1.f, when process nonconformities occur (as shown by process performance indicators), then corrective action is required to bring the QMS process under control. Remember, the corrective action process is not just for product related nonconformities. 

Þ      Processes must be continually improved (see clause 4.1f) through setting realistic, measurable (see clause 5.4.1) objectives- Planning for continual improvement requires a review of process data, resources and controls to bring about the desired change. More on this when we look at clause 8.4. 

Þ      Clause 4.1a – 4.1.f must be applied to all QMS processes. Note also that many TS 16949 clauses (e.g. clause 7.2; 7.4; 7.6; etc.), require specific processes to be identified and controlled in your QMS. I will highlight all these process as we cover the standard. 

Þ      Make sure you include all outsourced processes affecting product quality, in the scope of your QMS. An outsourced process is any value-adding activity related to your product or service, that is performed by an external organization such as a subcontractor, sister facility, etc.  Note that the external organization may perform the outsourced activity at their facility or yours. A manufacturing company may outsource welding, heat treatment or painting of product. A software company may outsource replication and packaging of its software product. A bank may outsource check clearing services.  

Þ      You must be able to demonstrate sufficient controls over outsourced processes to ensure that such processes are performed according to the relevant requirements of TS 16949. The nature and scope of such control will depend on the nature of the outsourced or subcontracted process and the risk involved.  

Þ      Outsourced processes may be controlled in any number of ways, e.g., providing the outsourcer with product specifications; your supplier quality manual that they must meet; asking for inspection and test results or certificates of compliance; validation of outsourced process; conducting product and QMS audits of your outsourcer; etc. The expectation here is that you flow down to your outsourcer, the relevant TS 16949 requirements that you would have to implement, had you performed the process at your own facility. (also see notes under clause 1.1 and clause 7.4.1 to better understand control of outsourcing). 

Þ      One last thing before we leave this all important clause. In systematically applying clause 4.1 requirements to each QMS process, we are intuitively using the PDCA approach to development of QMS processes.  

Þ      PLAN will call upon sub-clauses 4.1.a – 4.1e as well as other applicable TS 16949 clauses as shown above;   

Þ      DO is required by 4.1.f as well as other applicable TS 16949 clauses  

Þ      CHECK is controlled by 4.1.e as well as other applicable TS 16949 clauses;  

Þ      ACT is governed by clause 4.1.e-f as well as clause 8.  

Þ      Please review clause 4.1 and section 0.2 Process Approach of this document several times as you go through the rest of this standard. 

Þ      With a bit of process-mapping practice with the different types of processes, you will understand better the above explanation points and tips and will be able to develop and implement an effective QMS. There are also many useful tools available to facilitate this.  

Þ      The above paragraphs covering control of outsourcing also apply to prototype programs (see clause 7.3.6.2) and management of production tooling (see clause 7.5.1.5). 

Þ      Under TS 16949 clause 4.1.1 you cannot delegate technical responsibility for your product to your outsourcer. You must provide direction, control and monitor all phases of outsourcers supervise technical work – continuous interaction, reviews, inspections and approvals. 

You must flow down your customers PPAP requirements to those organizations you outsource to.