Understanding The ISO/TS 16949:2002 Standard 

7.5    Production & Service Provision  

7.5.1 Control of Production and Service Provision 

Plan and carry out production and service under controlled conditions which shall include (as applicable) the: 

a)    Availability of information that describes the product characteristics  

b)    Availability of work instructions, as necessary 

c)    Use of suitable equipment 

d)    Availability and use of monitoring and measuring devices 

e)    Implementation of monitoring and measurement 

f)    Implementation of release, delivery and post-delivery activities 

7.5.1.1 Control Plan (CP) 

Develop Control Plans for:

Þ            For system, subsystem, component or material level for the product supplied, including processes for bulk materials and parts 

Þ            Pre-launch & production taking into account design & manufacturing FMEA outputs 

Control Plans shall include: 

Þ            Controls for manufacturing processes 

Þ            Customer required information 

Þ            Methods to monitor control over special characteristics (both - customer & organization) 

Þ            The reaction plan when processes become unstable or not statistically capable 

Þ            Review & update Control plans for changes that affect product, manufacturing process, measurement, logistics, supply sources or FMEA (see 7.1.4).  

Note:   Get customer approval if required, after review or update of the control plan. 

7.5.1.2         Work Instructions (WI) 

Have documented work instructions, accessible at work stations, for all employees responsible for processes impacting quality. 

These WI’s shall be derived from sources such as the Quality plan, Control plan and product realization processes 

Key Explanation Points and Tips: 

Þ      Identify and control all production processes as per clause 4.1; 7.l and 7.5. Show the interaction of these processes with other processes. Use the APQP reference manual to plan and control production and service activities.  

Þ      The key output of the APQP (your quality plan) process are control plans and work instructions. Each part must have a control plan, but in many cases, family control plans may cover a number of similar parts produced using a common process 

Þ      For each product or part family, control plans must cover all production process steps from - receipt of materials, production, packaging, storage, delivery and even post-delivery activities such as installation or training.  

Þ      Consider using FMEA’s and control plans in other areas of your organization, such as equipment and facility maintenance; laboratory; tooling operations, etc. 

Þ      Control plans and work instructions originate as an output from Design and process FMEA’s (see clause 7.3.2.3 and 7.3.3.2). They define complete controls for the manufacture of product. Use them for pre-launch and production of end product, sub-assemblies, components and/or materials. They must include the customer’s and your special characteristics, any other customer required information and a reaction plan when processes fail. Review specific requirements at OEM customer or IATF websites. 

Þ      Work instructions may be viewed as a subset of your quality plan and may relate to a specific task or activity of your overall product realization process (e.g. setting up a machine; performing an inspection; packaging a product). If you determine that work instructions are needed at specific points in your process, then they must be readily available and relevant i.e. current or right version (see clause 4.2.3d). Note that work instructions may exist in may forms – narrative; graphical; audio; video; physical display; etc. Review specific requirements for work instructions at OEM customer or IATF websites. 

Þ      In combination, these documents address what has to be made; how much has to be made; when it has to be made; by whom; in what sequence; how it has to be made; what production equipment to use; what measurement and monitoring tools to use ; when to inspect; how much to inspect; what to do if problems arise, etc.  

Þ      These documents are dynamic and must be updated for the changes specified in 7.5.1.1. Your control plans must reference the work instructions specified for the process steps.   

Þ      Don’t forget to use the multi-disciplinary approach in developing your Control Plans. Clauses related to clause 7.5.1.1 include - 7.1.4; 7.3.6.3; 7.3.1.1; 7.3.3.2; 7.3.2.3; 7.3.6.2; 8.2.3.1; 4.2.3.1; 8.5.2. 

Þ      To improve your QMS, it will be very useful to draw a flow chart to link the flow and interaction of the activities and sub-processes covered by these clauses, e.g. many organizations overlook reviewing and updating their FMEA’s and control plans for corrective action taken to address a manufacturing process problem. 

Þ      Collectively, these documents include or reference the following information: 

Þ      Current engineering level/date; customer or your special characteristics; inspection and test instructions with acceptance criteria (see clause 7.1.2 and 8.2.3.1); material identification and disposition instructions; operation name and number keyed to the process flow diagram; part name, number and family; reaction plans; relevant engineering and manufacturing standards; required tools, gages and other equipment; revision dates and approvals; SPC and other process monitoring requirements; tool-change intervals and set-up instructions; visual aids, etc. 

Þ      Production personnel must have timely access to all information relevant to their activities. There may be serious risk to production flow, if such information is unavailable or untimely. 

Þ      Clause 7.5 does not require a ‘documented’ procedure. However, you must identify and document all processes addressing this clause as part of your QMS (see clause 4.1). For these processes, you must also identify what specific documents, controls and resources are needed (see clause 4.2.1d. and 7.1b.). You could use your control plan; a documented procedure or other combination of specific practices, procedures, work instructions; and other documents and methods. Look at the risks related to your product, processes and resources in determining the extent of documented controls you need to have (also see clause 4.2.1 notes).  

Þ      Performance indicators (to measure the effectiveness of production processes in meeting requirements and achieving quality objectives) should focus on reducing variation in and improving production p rocesses and related use of resources.  

Þ      Indicators for production processes be product or process related. Product related indicators may include reduction - in defect rates, PPM’s (defective parts per million), scrap rates, waste and rework; improvement in on time delivery, inventory turns (see clause 7.1a).  

Þ      Production process related indicators may include – reduction in set-up time; run rates; process cycle time; production scheduling and operator errors and omissions; etc. 

7.5.1.3 Verification of job set-ups 

Verify job set-ups whenever performed as at initial run, material or job change.  

Provide WI’s to set up personnel & use statistical methods of verification where applicable 

Note: Last-off part comparisons are recommended 

Key Explanation Points and Tips: 

Þ      Job set-ups relate to changes in tooling, equipment, materials, shifts, personnel, etc. You must determine the importance of set-ups in terms of time taken and risks related to product quality, in determining the extent of set-up verification, methods used and details of work instructions made available to set-up personnel. Tooling FMEA’s provide very useful input to determine this. 

Þ      Verification of job set-ups may include – data on and comparison of the last series (quality records, corrective actions); completeness of equipment and documentation for production, inspection and testing; responsibilities for release after set-up; disposition of pre-launch or set-up scrap; comparisons of last piece with specified requirements and first piece of new run, etc. Review specific requirements for job set-ups at OEM customer or IATF websites. 

Þ      Include job set-up controls in your control plans.