Understanding The ISO/TS 16949:2002 Standard 

7   PRODUCT REALIZATION  

7.1 Planning of Product Realization 

Your organization shall plan and develop the processes needed for product realization 

This planning shall be consistent with the requirements of other processes of your QMS (see 4.1) 

In planning product realization, you organization shall determine, as appropriate: 

a)    Product quality objectives and product requirements 

b)    The processes, documents and resources specific to the product 

c)    Specific product verification, validation, monitoring, inspection, and test activities; and criteria for product acceptance  

d)    Records needed as evidence that realization processes and resulting product meet requirements (see 4.2.4) 

Keep such planning output in a form suitable to your organization’s method of operations 

Note 1:   A quality plan is a document that specifies the QMS processes (including product realization processes) and resources applied to a specific product, project, or contract.  

Note 2:   An organization may also apply the requirements of 7.3 to the development of the product realization processes 

Note:       You may use project management or APQP to achieve product realization. Advanced Product Quality Planning (APQP) focuses on error prevention and continual improvement (as contrasted with error detection) and uses a multidisciplinary approach. 

7.1.1   Product Realization Planning - Supplemental  

Your Quality Plan shall include customer requirements & references to their technical specifications.  

7.1.2   Acceptance Criteria 

Define acceptance criteria & get customer approval where required. For attribute data sampling, the acceptable level shall be zero defects (see clause 8.2.3.1). 

7.1.3   Confidentiality 

Keep confidential - customer contracted products and projects under development and related product information 

7.1.4   Change Control 

Have a process to control & react to changes from internal, customer or supplier sources, that impact product realization. Your controls shall: 

Assess the changes and their effects. 

Define verification and validation activities (for these changes) to ensure compliance with customer requirements. 

Validate changes before implementation. 

Review with your customer, any changes to propriety designs, impact on fit, form and function, to ensure that all effects are evaluated 

Perform any additional verification/ identification, when required by the customer, e.g. new product introduction 

Note 1 : Notify & get approval from your customer, for any product realization change affecting customer requirements. 

Note 2 : This clause for change control applies to changes to product as well as manufacturing processes. 

Key Explanation Points and Tips: 

Þ      Clause 7.1 is essentially a repeat of clause 4.1, but applied specifically to product realization processes (see clause 4.1 explanation points – COP’s). The focus is on controls governing the making of product to meet customer requirements and all the QMS processes that, directly or indirectly, make this happen. Review specific product realization requirements at OEM customer or IATF websites. 

Þ      Product realization processes may include – customer related processes (sales and marketing); design and development; production; shipping; receiving; packaging; measurement and monitoring of product and processes, customer satisfaction feedback; etc., whether performed onsite or off-site.  

Þ      Some of the support processes that apply to product realization processes include - document control; record control; human resources; infrastructure provision and maintenance; IT; purchasing and materials management; laboratory services; and control of monitoring and measuring devices, etc. 

Þ      You must show the sequence and interaction of these processes. The APQP is an excellent tool to accomplish this. Using the APQP methodology, your organization can identify the processes and controls needed to plan product realization from – identification and understanding of customer requirements; product design and development if applicable; manufacturing design and development; manufacturing and delivery. The focus of APQP is defect prevention and continual improvement, as well show how the processes link and interact with one another.    

Þ      The notes to 7.1 also permit you to use other project management tools or clause 7.3 requirements to develop product realization processes. You may need to consult your customer to confirm such alternate methods. 

Þ      The Quality Plan (Control Plan) is the output of the APQP process and is used to deploy product realization. The Control Plan must include product details and control characteristics; process sequence and process control parameters; specific resources needed to make, verify and deliver product; product and process monitoring and measurement controls; plans to control and correct any product or process nonconformities.  reference to support processes; documents needed (such as work instructions or engineering specifications, etc.) and details of records to be kept;  

Þ      Focus on defect prevention in planning the controls for product realization 

Þ      Quality objectives; product requirements as well as product realization process requirements may come from the customer, your own organization, regulatory bodies and industry standards or codes. 

Þ      Quality objectives may include – defect rates; PPM’s; scrap rates, etc. Requirements or criteria for the product may include – physical; dimensional; functional, etc, and their related measurements, tolerances and acceptance levels. In many instances, depending on the nature of the product, the customer may specify objectives and requirements /criteria for the product realization processes as well. Obtain customer clarification and approval where required. 

Þ      Many customer requirements may come from the sources and reference documents I listed on page 1 of this document. You must pay careful attention to this listing as they may be as applicable as customer contracts and product specifications.  

Þ      Required verification, validation, monitoring, inspection and test activities must apply to all processes identified for product realization and must be defined in your FMEA’s, Control Plan, work instructions, and other documents used for product realization. 

Þ      Access to storage of confidential documents and data (electronic or hard copy) should be controlled.  Be extra careful of confidentiality requirements relating to new projects and changes. Obtain clarification and approval from your customer when outsourcing production or needing to disclose technical information when sourcing materials. 

Þ      Change control is a very important part of the product realization process. It applies to ANY change in product realization and includes product and manufacturing process changes. Uncontrolled changes lead to both customer and internal quality problems. The defined process must include authority for change and consistency of implementation and communication.  

Þ      For effective change control, follow the applicable requirements of the APQP methodology for assessing, verifying and validating product realization changes before implementing. Comply with any customer requirements for notification and approval of changes.  

Þ      Your change control process must include – responsibility; evaluation; verification and validation; frequency; timing; method; communication; training; documentation; update of affected activities and documents; implementation; use of multi-disciplinary approach; checklists; etc., for product realization changes. 

Þ      Changes may arise from customer complaints; feedback from the field; new technology; supplier and material changes; internal or customer driven changes; process improvements; SPC data; etc. 

Þ      Product realization changes may affect several linked activities and documents. Such as – clauses (4.2.3.1; 7.3.6.3; 7.3.2.3; 7.3.3.1; 7.3.3.2; 7.3.6.2; 7.5.1.1 and 7.5.1.2). These cover customer engineering specifications; FMEA’s (design and process); Control Plans; design record; inspection instructions; machine process parameters; material specifications; measuring equipment; part approval requirements; technical drawings; and work instructions.  

Þ      Where any of the product realization processes are done off-site (e.g. at head-office), your QMS must include the off-site processes within your QMS and ensure that such processes comply with TS 16949 requirements. Evidence of the off-site facility’s compliance may include - a copy of their TS 16949 certification; results of their internal audits to TS 16949; auditing the outsourced facility; etc. The expectation is to flow down to the off-site facility, the relevant TS 16949 requirements that you would have to implement, had you carried out the process at your own facility. 

Þ      Performance indicators, (to measure the effectiveness of product realization in meeting requirements and achieving quality objectives,) will be specific to each realization process and focus on reducing variation and waste in realization processes and related use of resources. Objectives may be used to monitor and improve process – productivity; reduction of cycle time, errors, omissions and failures; etc.  

Þ      You must also consider indicators to measure product performance such as - reduction in defect rates, PPM’s (defective parts per million), scrap rates, waste and rework; improvement in on time delivery (see clause 7.1a); product returns from customer; etc.