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ISO 9001-Clause 7.5

ISO 9001-Clause 7.5  Production and service provision

ISO 9001-Clause 7.5.1 Control of production and service provision

ISO 9001 Requirement

The organization shall plan and carry out production and service provision under controlled conditions.
Controlled conditions shall include, as applicable,
a) the availability of information that describes the characteristics of the product,
b) the availability of work instructions, as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring equipment,
e) the implementation of monitoring and measurement, and
f) the implementation of product release, delivery and post-delivery activities.

Explanation:

This clause provides a list of control requirements that you may use, if applicable to your business. Identify and control all production process. Show the interaction of these processes with other processes. Use your product, project or contract quality plan to control production and service activities. Schedule your production taking into consideration customer delivery requirements, production capacity and capability, material availability and usage, personnel availability and usage; storage; etc.  Carefully define and document the interaction of your production scheduling process with your logistics processes such as inventory management, customer communication, traffic and shipping control, packaging and labeling, sales and billing. Use quality plans to control your production processes. Quality plans 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, what to inspect, when to inspect, how much to inspect, what to do if problems arise, etc.Your quality plan must cover all production process steps from receipt of materials, production, packaging, storage, delivery and even post-delivery activities such as installation or training. Your quality plans are dynamic and must be updated for the changes in product specifications or process parameters; resources used; monitoring or measurement requirements, etc. Your quality plans should reference any work instructions specified for the process steps. 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 for 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. Note that work instructions may exist in may forms such as  narrative, graphical, audio, video, physical display etc. 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 quality plans for corrective action taken to address a manufacturing process problem. Production personnel must have timely access to all information relevant to their activities including specific work instructions if necessary. There may be serious risk to production flow, if such information is unavailable or untimely. You must identify and document all processes addressing this clause as part of your QMS  For these processes, you must also identify what specific documents are needed for effective planning, operation and control of production activities. These documents may include – a product quality plan; work instructions; documented procedure; etc., combined with unwritten practices, procedures and methods. Look at the risks related to your product, processes and resources in determining the nature and extent of documented controls you need to have. 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 processes and related use of resources.

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

ISO 9001-Clause 7.5.2  Validation of processes for production and service provision

ISO 9001 Requirement

The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.  Validation shall demonstrate the ability of these processes to achieve planned results.
The organization shall establish arrangements for these processes including, as applicable,
a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records (see 4.2.4), and
e) revalidation.

Explanation:

Validation is usually required where product cannot be verified without damaging or destroying the product, e.g. some types of welding, heat-treatment, painting, electroplating, rust-proofing, etc. In such instances, the quality of these activities may only be discovered after use. This would generally not be acceptable due to safety (e.g. weld) or aesthetic (evidence of rust or dullness of chrome) reasons.  In the case of a service such as pizza delivery within 30 minutes of order placement, if the timeliness of delivery is not verifiable, then validation would be required. However, most service-oriented businesses (e.g. delivery; call center) have some form of monitoring during service execution to ensure service quality.
Validation involves conducting capability studies using a combination of resources technology, equipment, materials, environment, competent personnel, and production and testing methods that consistently result in a quality product or service.
Document the specific procedures, methods, and combination of resources that achieve this capability, and keep records of ongoing studies to show that you are maintaining this capability. Validation may also require customer or regulatory approval of the process. You must keep appropriate records of process validation showing both the achievement of planned results as well as the ongoing maintenance of such capability. If you change any part of the proven process capability for e.g. materials, equipment or personnel, etc., you must revalidate i.e re-prove the changed process. It is up to each organization to determine what combination of resources and methods will provide the required consistent process capability and quality of product or service. Include as appropriate, these validation controls in your quality plans. If the nature of your product or service is such that it does not require validation and where product can always be verified by subsequent monitoring or measurement prior to delivery, then you must clearly state this exclusion to your QMS scope, in your Quality manual.
Performance indicators to measure the effectiveness of processes that validate production processes may include reduction in  defect rates, PPM’s (defective parts per million), validation cycle time, revalidations etc.

ISO 9001-Clause 7.5.3  Identification and traceability

ISO 9001 Requirement

Where appropriate, the organization shall identify the product by suitable means throughout product realization.
The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization. Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records (see 4.2.4).
NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.

Explanation:

There are three distinct control requirements specified here.

  • Product identification: It means knowing the identity of  yours or customer supplied product from  incoming receipt of materials,  raw material storage, use in production, work in progress, finished product storage, and delivery of product to the customer. Product identification can be controlled using physical and electronic methods.
  • Product status: It means knowing the quality status (good or bad) of materials and product through each of the above stages. Product status can be controlled using physical and electronic methods.
  • Unique Product Identification: It is not a mandatory requirement under ISO 9001, unless contractually required by customers or regulatory bodies. In certain industry sectors such as the automotive or aerospace or pharmaceutical industry, unique product identification is mandatory for safety, regulatory and risk management reasons. This usually involves keeping detailed records of product manufacturer such as material, equipment, personnel, processes, production, inspection and test details, etc., for individual products or production batches. These records help to trouble-shoot product and process problems, resolve customer complaints, and enables continual improvement of product and process. In many instances, it also reduces cost, risk and use of resources by narrowing the problem down to a specific cause or instance. Depending on the product, the OEM may specify the degree of unique identification and traceability required.

While this clause does not call for a specific documented procedure, these controls may be included in your product realization processes through your product quality plans, work instructions and other specific documentation. Examples of product identification and test status include physical tags, bar code labels linked to computer records; MRP systems tracking specific production runs/lots,  automated production transfer processes, etc. Performance indicators to measure the effectiveness of processes that control identification and traceability may include  reduction in identification errors and omissions; product quality status errors and omissions; and traceability errors and omissions.

ISO 9001-Clause 7.5.4  Customer property

ISO 9001 Requirement

The organization shall exercise care with customer property while it is under the organization’s control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer and maintain records (see 4.2.4).
NOTE Customer property can include intellectual property and personal data.

Explanation:

Customer property may include material, production equipment, tooling, measuring and test equipment, facilities, transport vehicles, returnable packaging, intellectual property such as drawings, specifications or proprietary information, product returned for servicing under warranty, product sent for outsourced work, etc.
All customer property is exposed to the risk of being damaged, lost, misused, misplaced, stolen, become unsuitable or obsolete for use. You must establish controls for each of these risks. Notify the customer in writing if their property is lost, damaged or otherwise found to be unsuitable such as perishable past its shelf life for use. Control to minimize the risks to customer property include inventory management, preservation and storage, identification, status and traceability indicators, maintenance, notification, traffic flow, authorized use, restricted access, etc. Marking customer property with a unique identification number that can be traced to a record that provides details of ownership is one of many acceptable controls.
This clause requires records to be kept of customer property that is lost, damaged or otherwise found to be unsuitable for use. This implies  tracking the storage and use of and quality status, of customer property.
While this clause does not call for a specific documented procedure, these controls may be included in your product realization processes through your product quality plans, work instructions and other specific documentation. Many of the controls needed for clause 7.5.3 Identification and traceability and clause 7.5.5 Preservation of product apply to customer property. The processes, controls and documentation for these other clauses could be expanded to include customer property.If the nature of your business does not require the use of any customer property, then you must clearly state this exclusion to your QMS scope, in your Quality manual.
Performance indicators to measure the effectiveness of processes that control customer property may include reduction in identification errors and omissions, loss due to damage or unsuitability, scrap, rejects, etc., as well as increased customer property turnover rates.

ISO 9001-Clause 7.5.5  Preservation of product

ISO 9001 Requirement

The organization shall preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation shall include identification,  handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.

Explanation:

All raw materials, work in progress, finished product, supplies, customer provided materials or product, product sent for outsourced work, etc., are subject to risk of being damaged, lost, misused, misplaced, stolen, become unsuitable ,perishable or obsolete i.e. past shelf life for use. This could occur during receipt, handling, storage, use in production, and transportation to the customer, etc. These could be
Controlled using identification, status and traceability indicators, inventory cycle counts and condition evaluation, stock rotation methods such as FIFO, just in time, tracking shelf life,  special, controls for restricted access, handling and storage of hazardous materials, climate and environment, maintenance procedures, bar codes, training, use of special equipment for handling, condition reports, etc. These controls may be included in your product realization processes through your product quality plans, work instructions and other specific documentation. Many of the controls needed for clause 7.5.3 Identification and  traceability apply to preservation of product.
Performance indicators to measure the effectiveness of processes that control preservation of product may include reduction in obsolete and spoils materials an product (e.g., fresh produce, fruits, or frozen foods), identification errors and omissions, rejects, waste, scrap, etc., and increase in inventory turnover and material/product availability, and product safety.

Audit Checklist:

For Clause 7.5.1:

  • How are controls applied to the processes to ensure that products & services are supplied to the Customer correctly?
  • Are production & service operations controlled through, as applicable availability of information on characteristics of product?
  • Are production & service operations controlled through, as applicable availability of work  instructions?
  • Are production & service operations controlled through, as applicable use & maintenance of suitable equipment?
  • Are production & service operations controlled through, as applicable implementation of monitoring activities?
  • Are production & service operations controlled through, as applicable implementation of defined processes for release, delivery and post-delivery activities?
  • Are production & service operations controlled through, as applicable availability & use of measuring & monitoring devices?

For Clause 7.5.2:

  • Have any processes whose output cannot be checked? If so, how are these processes controlled?
  • Where resulting output cannot be verified by subsequent monitoring or measurement, are the production and service processes validated through as applicable defined criteria for review and approval, approval of equipment and qualification of personnel use of specific methods & procedures and requirements for records and re-validations?
  • Does validation demonstrate the ability of these processes to achieve planned results?

For Clause 7.5.3:

  • How are items identified? How do you indicate whether products/services are good (or not) to use? Can traceability information (if asked) be found on what was delivered?
  • Are various products suitably identified throughout production and service operations?
  • Are the product status identified w.r.t. measurement & monitoring requirements?
  • Where traceability is a requirement, are unique identification of product controlled and recorded.

For Clause 7.5.4:

  • Does the Customer supply any product, property or information? If so, is it checked for suitability?
  • Are customer property provided for use or incorporation into the product identified, verified, protected & safeguarded?
  • If the customer property that is lost, damaged or otherwise unsuitable for use, is this reported to  the customer and recorded?

For Clause 7.5.5:

  • How is incoming, in-process and final product/ service handled? Stored? How are products/ services  protected?
  • Are the conformity of product during internal processing and delivery to intended destination preserved?
  • Does this include identification, handling, packaging, storage and protection of the product and constituent parts?

Mandatory Procedure : Not applicable

Mandatory record:
For Clause 7.5.1:Not applicable
For Clause 7.5.2:

Demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement for e.g Schedule of achieved results

pdf Example of Process parameter chart for validation and first piece approval

For Clause 7.5.3:

The unique identification of the product, where traceability is a requirement for e.g Equipment register

pdf Example of Tags
pdf Example of format of Equipment register

For Clause 7.5.4:  

Customer property that is lost, damaged or otherwise found to be unsuitable for use for e.g Defective material report, Delivery note

pdf Example of format for list of customer supplier items

For Clause 7.5.5:Not applicable
Evidence/Implementation document ( Not mandatory but helps in fulfillment of requirement):
For Clause 7.5.1:

Documents are needed for effective planning, operation and control of production activities: a product quality plan, work instructions, production planning,Job Cards, Workmanship Standards, documented procedure, Breakdown maintenance report, Preventive maintenance report, etc., combined with unwritten practices, procedures and methods.

pdf Examples of Work Instructions
pdf Examples of Production schedule
pdf Examples of Inspection and test plan
pdf Example of format for Machine Breakdown Maintenance Report
pdf Example of format for Machine preventive Maintenance Chart
pdf Example of Procedure of Production
pdf Example of Procedure of Service

For Clause 7.5.2:

Competence Training,External test records,Equipment validation, Test piece records

pdf Example of format of Special Process Qualification report

For Clause 7.5.3:

ID Tags,Barcodes,Unique  product ID
Examples of product identification and test status include physical tags, bar code labels linked to computer records, MRP systems tracking specific production runs/lots, automated production transfer processes

For Clause 7.5.4:

List of Customer Property, Control to minimize the risks to customer property include inventory management, preservation and storage, identification, status and traceability indicators, maintenance, notification, traffic flow, authorized use, restricted access, etc. Marking customer property with a unique identification number that can be traced to a record that provides details of ownership is one of many acceptable controls.

pdf Example of format for list of customer supplier items
pdf Example of format for list of customer drawing

For Clause 7.5.5:

Procedure For Handling, Controls include  identification, status and traceability indicators, inventory cycle counts and condition evaluation, stock rotation methods such as FIFO, just in time, tracking shelf life, MRP systems for tracking requirements and usage, special, controls for restricted access, handling and storage of hazardous materials, climate and  environment, maintenance procedures, bar codes, training, use of special equipment for handling, condition reports, etc.

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