Section 7 of the internal audit checksheet is very long and time consuming. It includes over 100 questions covering several dissimilar areas. This check sheet includes questions on product realization (production) and order entry including all customer contacts. It also includes design control, purchasing control, inventory control and control of measuring equipment.
Because the checklist touches so may areas and will require interviewing so many different people, you may want to split this audit between different people or different days. You will need to get access to production personnel, design engineers, purchasing personnel, order entry and inventory people.
| Question | Reference Documents | Notes |
| 7 Product Realization | ||
| 7.1 Planning | ||
| Is the planning of product realization process integrated into the entire quality system? (specifically management review) | ||
| Are the following being reviewed during the product planning: | ||
| a) Quality objective, Product specification | ||
| b) The need for additional processes, resources, and documentation | ||
| c) Requirements for verification, validation, monitoring, inspection, and test requirements | ||
| d) Are record maintained for all stages of the development process | ||
| 7.2 Customer Related Processes | ||
| Has the organization determined the: | ||
| a) Requirements specified by the customer including delivery and post-delivery activities (training and installation, support, etc) | ||
| b) Requirements not specified by the customer but necessary to use the product for its intended purpose (proper application, safe operation, integration with other products ) | ||
| c) Regulatory and statutory requirements related to the product | ||
| d) Any additional requirements determined by the organization (limitations, warranty, special requirements) | ||
| 7.2.2 Review of the requirements related to the product | ||
| Are the requirements reviewed prior to commitment to the customer (acceptance of contracts or change orders) | ||
| Does the company have the following information prior to commitment: | ||
| a) Full product specification | ||
| b) Contract or order requirements difference from previous orders | ||
| c) Ability of the organization to meet the customer requirements | ||
| Are the order review and actions from the order review recorded and maintained as a quality record? | ||
| Is the critical order information 100% complete prior to acceptance? | ||
| Are changes to the product requirement (including change orders) communicated to all appropriate levels of the organization? | ||
| 7.2.3 Customer Communication | ||
| What system does the company use for customer communication of: | ||
| a) Product specifications and information (salesmen, web site, spec sheets) | ||
| b) Inquiries, contracts, change orders and new orders | ||
| c) Customer feedback including customer complaints (like Corrective and Preventive Actions) | ||
| 7.3 Design and Development | ||
| Are product design and development activities planned and controlled? Using what documents? | ||
| Does the design and development plan (sometimes called a quality plan) include: | ||
| a) Different stages of development | ||
| b) Design reviews at appropriate stages | ||
| c) Verification of the design to the design specifications | ||
| d) Validation (official sign-off) of the design against the critical specifications | ||
| e) Responsibilities and authorities of personnel involved in the design process | ||
| How are the interfaces between different groups defined and managed to ensure proper communication? | ||
| Is the planning output updated as the design progresses (ex: revision control of specification) | ||
| 7.3.2 Design and Development Inputs | ||
| Are inputs relating to the product design requirement defined documented and maintained as a record (sometimes call a design specification)? | ||
| Does the design and development input include: | ||
| a) Functional and performance requirements? | ||
| b) Applicable statutory, regulatory, and legal requirements? | ||
| c) Applicable information for previous designs (are they learning from their mistakes)? | ||
| d) Other requirement essential to design and development | ||
| Are the design inputs review for overall integrity, quality and completeness (design review)? | ||
| Are incomplete, conflicting and ambiguous requirements correct? | ||
| 7.3.3 Design and Development Outputs | ||
| Are the outputs of the design and development process in a form that allows for verification against the design and development inputs? | ||
| Does the design and development output: | ||
| a) Meet or exceed the design and development input ( | ||
| b) Include appropriate information for fabrication, purchasing, production and service of the product? | ||
| c) Contain and reference product acceptance criteria | ||
| d) Specify the product characteristics that are essential for the safe and proper use (limitation)? | ||
| 7.3.4 Design and Development Reviews | ||
| Are systematic reviews completed at suitable stages in accordance with the design and development plan? | ||
| Do design reviews evaluate the ability of the design to meet the ?design specification?? | ||
| Do design reviews identify problems and propose necessary corrective actions? | ||
| Do design reviews include appropriate representatives from all the areas affected by the design? | ||
| Are results of design reviews maintained as quality records? | ||
| 7.3.5 Design Verification | ||
| Is the design verified against the product design specifications? | ||
| Are the verification results maintained as quality records? | ||
| 7.3.6 Design Validation | ||
| Is the design validated by qualified personnel? | ||
| Is the design validation performed to confirm that the product meets the design specification? | ||
| Is validation testing completed prior to delivery of the product? | ||
| Are the results of the validation testing maintained as quality records? | ||
| 7.3.7 Design Control | ||
| Are design specification changes identified and recorded? | ||
| Do design changes include evaluation of effects on subcomponents and existing products in the field? | ||
| Are design specification changes reviewed, verified and validated before implementation? | ||
| Are design specification changes recorded and maintained as a quality record? | ||
| 7.4.1 Purchasing Control | ||
| How are the purchasing processes controlled to ensure that the purchased products and services conform to the specifications or requirements? What is the procedure number? | ||
| How are critical safety-related parts or key components and services given special attention? | ||
| Are suppliers selected and evaluated based on their ability to supply conforming product? | ||
| How does the organization establish criteria for selection and evaluation of suppliers? | ||
| Are supplier periodically re-evaluated to determine their compliance with the requirement of the company? | ||
| Are evaluations maintained as quality records? | ||
| Are copies of corrective actions sent to suppliers maintained as quality records? | ||
| 7.4.2 Purchasing Control | ||
| Does the purchasing information describe the requirements for approval of products, procedures and equipment? | ||
| Does the purchasing information describe the requirements for a quality management system (including ISO 9000 or equivalent)? | ||
| How are the specifications for purchased parts and services checked prior to communication to the supplier? | ||
| 7.4.3 Verification of Purchased Product | ||
| Are inspection and incoming testing requirements specified to ensure that purchased parts conform to the specification (Give an example)? | ||
| Are inspection and incoming testing requirements specified in the purchasing information whenever the inspection or incoming testing is completed by the supplier (Give an example)? | ||
| 7.5.1 Control of Production and Service Provision | ||
| Is information about the product requirements available to production and service personnel? | ||
| Are work instructions used where required? | ||
| Is suitable equipment available to production and service personnel? | ||
| Is monitoring / measuring equipment available to production and service personnel? | ||
| Is information about the release, delivery and post delivery (installation and service) available to production and service personnel? | ||
| 7.5.2 Validation of Processes for production and service provision | ||
| Does the company validate products and service to assure no latent failures? | ||
| Are process validated against the quality plan? | ||
| Are criteria for review and approval of production and service processes defined? | ||
| Is production and service equipment approved for use? | ||
| Are production and service personnel qualified for the appropriate processes? | ||
| Are record requirements established as part of the quality plan? | ||
| Are plans made for re-validation if required? | ||
| 7.5.3 Identification and Traceability | ||
| Is the product uniquely identified throughout the product realization (production process)? | ||
| Is the product status (conforming/non-conforming) identified with respect to measurement and monitoring requirements? | ||
| When tracibility is required, is the product uniquely identified and controlled? | ||
| Is the unique identification information maintained as a quality record? | ||
| 7.5.4 Customer Property | ||
| Does the company ever maintain customer property (including units return for service)? | ||
| Does the company exercise care with customer property while it is in the control of the organization? | ||
| Is customer property identified, verified, and protected? | ||
| If the customer property is lost, damaged or found unsuitable for use, is the condition recorded, reported to the customer, and is this information maintained as a quality record? | ||
| 7.5.5 Preservation of product | ||
| How is the product preserved during internal processing and delivery? | ||
| Is the product identified during processing? | ||
| Do preservation activities include handling, packaging, storage, and protection? | ||
| Are preservation activities applied to component and sub-assemblies? | ||
| 7.6 Control of Measuring and Monitoring Devices | ||
| Has the company determined the monitoring and measurement requirements needed to ensure conformity of the product to the requirements? | ||
| Have process been established ( and documented) to ensure that monitoring and measurement are carried out in a consistent manner? | ||
| Is measurement and monitoring equipment calibrated or verified at specified intervals prior to use? | ||
| Is measurement and monitoring equipment calibrated or verified against traceable international or nation standards (where ever possible)? | ||
| Is measurement and monitoring equipment adjusted or re-adjusted as necessary? | ||
| Is measurement and monitoring equipment identified with a calibration status? | ||
| Is measurement and monitoring equipment safeguarded against improper adjustment that could invalidate the measurements? | ||
| Is measurement and monitoring equipment protected from damage and deterioration during usage, maintenance and storage? | ||
| Has the company ever shipped, installed, or sold any product that was later found to be invalid due to measurement or monitoring errors? If so, were the action recorded (and maintained as a quality record)? | ||
| Are records of calibration and verification results maintained as quality records? | ||
| Where computer software is used for monitoring and measurement, is the software confirmed prior to initial use? | ||
| Is computer software (used in products) periodically reconfirmed? |