||Planning & Realization 4.1 (including control of outsourced processes), 5.4.2a, 5.4.2b, 6.1, 6.3, 6.4, 7.5.1c (ensuring equipment is suitable), 7.1, 7.5.2 (establishing special processes), 7.6 (measuring device needs identified), & 8.1 (establishing statistical techniques)|
PURPOSE: To understand
the activities needed to successfully plan for the identification, application,
sequence/interaction, implementation, and fulfillment of the business model
(a.k.a., quality management system or QMS), products, processes, and projects
needed to meet customer requirements and continually improve the effectiveness
of Pi-Co's QMS.
1. The planning activities in this flowchart are the considerations we need to evaluate each time we establish a new part number in our system, introduce a new/modify an existing process, outsource a process affecting product or service quality, or try to implement a significant project (ISO, facility moves or expansions, new computer systems, etc.) at Pi-Co, ensuring the integrity of the QMS throughout the process. If we fail to plan, then we should plan on failing.
2. When we establish a plan, it needs to be documented (output of planning) so we can understand what the product, process, or project is supposed to look like when it is done (quality objectives/product requirements), including the recognition of sequence/interactions of processes, as necessary. Work Order Routers, quality/control plans (when required), timelines, flowcharts, and/or checklists are a few of the ways we can document a plan. Whichever we use, allow for updates so we can see where we are and what is left. The Quality Planning Worksheet may be used to ensure all planning activities are considered.
3. CRITERIA: (as applicable)
- Do we understand and have we established the process?
- Do we have the equipment and/or tooling needed to do the job?
- Do we have what it takes to verify (inspect or test) the results?
- Do we have the right people for the job (skills, education, training, or experience)?
- Will the absence of documented procedures detailing the activities to be performed have an adverse affect on quality,
reliability, and/or our ability to meet requirements?
- Will the process require validation because we cannot completely ensure the product will meet all requirements
through the inspections or tests we perform (special process)?
If the answer to the second question is "Yes," refer to the "Establishing a Special Process" flowchart (embedded in this procedure).
5. Items included in a documented process are shown throughout this flowchart. Additional considerations are shown in the Quality Planning Table (embedded in this procedure).
6. The "Resource Management" section of this procedure describes the considerations and methods used to identify and provide for resources. If the resource involves new personnel, make sure we have a job description describing the need so we can hire someone with the right education, experience, training, and skills.
7. CRITERIA: (ensuring the integrity of the QMS is maintained)
- Can we introduce this new product without having an adverse effect on existing products?
- Can we introduce this new process without having an adverse effect on existing processes or products?
- Can we introduce this new equipment or software without having an adverse effect on existing equipment, software, or products?
8. When introducing a new product, process, piece of equipment, or software causes a conflict with what we already have or do, we need to try to understand this ahead of time and work on a solution before it becomes a problem. In some cases, it causes us to rethink the allocation of resources. Exploiting our weaknesses before they exploit us!
- Will existing inspection and/or testing methods provide a means for verifying the desired results have been achieved?
- Do we have the necessary measuring and monitoring equipment for the inspections and/or tests to be performed?
- Have we determined when an inspection and/or test is to be performed and have we established methods for ensuring it will be performed at the appropriate time?
- Do we have documented acceptance criteria?
- Have we determined how we will demonstrate (prove) conformance to specified requirements (acceptance criteria) or show (prove) our business model (QMS) is operating effectively?
If the answers to either the first or second question is "No," and we are not going to be able to put these things in place, refer to the "Establishing a Special Process" flowchart (embedded in this procedure).
10. Based upon the types
of shortcomings derived from the series of questions in note 9, develop the
necessary inspection/test methods, inspection or test stages, acceptance
criteria (including clarification of those that are subjective), and the records
to prove we have fulfilled requirements. Two things to keep in mind when
assessing and fulfilling these needs:
- When determining the inspection or test to be used, new instrumentation (testers, measuring or monitoring devices, etc.) may be needed, and
- Sometimes there is no known method or instrument currently available for the inspection or test being performed.
When we don't have the capability (or it does not currently exist), we have to figure out what the appropriate method or instrument is and acquire it in time to be able to verify we have achieved the desired results for the new product, process, or project.
11. When the planning process is complete (typically when the product, process, or project is finished), file the records per requirements outlined in the records section of the Master Control Plan (embedded in Document & Records Control). When this involves products or projects, we are showing we met desired results. For equipment and/or processes, we are showing it is approved for use.
|Along with the considerations described in this procedure, the
following items should be considered and addressed, as applicable, when
developing documentation associated with planning activities for
products, processes, or projects.
(Items needing to be addressed in the Work Order Router, as applicable.)
- Determine if existing methods for identifying product (including those related to preservation) are sufficient or if the customer has additional requirements.
- If traceability is a specified requirement (and exceeds our current method of traceability), include provisions that ensure we will live up to the expectation.
- Include references to requirements that must be lived up to and are not part of the drawings or specifications.
- Establish steps for inspections or tests to be performed at the necessary stages.
- Include any special handling, protection, and shipping (including packing, packaging, marking, and delivery) requirements.
- Determine if any new production processes are required that will need to be designed, implemented, and validated. Also consider preventive maintenance and process control requirements.
In some cases, it makes
more sense to address these items in process documentation (see the
Processes & Projects section of this table).
Virus Software and System Backup Plan:
Process - A series of events or planned arrangements intended to produce a desired result. An example of this is the process employed for producing a product or the Work Order Router. The Work Order Router outlines the materials/equipment needed and any operating parameters to be used to produce the product.
Product/Part - Any item produced to meet Pi-Co and/or customer requirements.
Project - A significant event that needs to be planned for the sake of ensuring a successful outcome will be achieved. Projects may involve the introduction of new processes or products.
DID YOU KNOW!
Numbers shown throughout this document are clause numbers from ISO9001:2008 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Can we verify results?" diamond with "7.6 & 8.1" referenced. This means the notes or documents referenced, address the requirements of 7.6 & 8.1 of ISO9001:2008.