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)

Revision: 4/16/2009

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.

NOTES:
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)?
4. CRITERIA:
- 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!
9. CRITERIA:
- 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.

 

QUALITY PLANNING TABLE

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.

PRODUCTS
(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).

PROCESSES & PROJECTS
(May be addressed in a business model documentation (QMS), timeline, Quality Planning Worksheet, flowchart, or other means of expressing the plan.)

- Establish revision control for any documents developed that should be included in the business model (when the absence of that detail could have an adverse effect on quality).
- Determine if existing methods for identifying process or project outputs (may be product) are sufficient.
- Consider special requirements imposed on us by the customer and/or any regulatory or legal requirements.
- If a process or project has special traceability requirements (typically involves products), include provisions that ensure we will live up to the expectation.
- Ensure any equipment introduced as a result of the new process or project is suitable, used in a suitable environment, and have established and implemented maintenance requirements.
- Ensure compliance with reference standards/codes, quality plans, and/or documented procedures.
- Determine and implement the methods needed to monitor and control process parameters and/or product characteristics.

 

Establishing a Special Process 7.5.2

NOTES:
A. A special process is any process where it cannot be proven that Pi-Co has met applicable requirements (customer, legal, regulatory, etc.) by verifying the resulting output. When this is the case, we have to know the process employed, the equipment used, and the people performing the task are capable of achieving the desired results. In other words, when we cannot prove we have met the applicable requirements because we cannot inspect or test the item in a way to prove it, we have to know (prove) the process, the equipment, and the people can do it without the proof of a definitive inspection or test.

B. As we begin to develop a process, we need to define the criteria to be used to review and approve the process. These includes:
- approving the equipment,
- qualifying the people, and
- approving any methods/procedures.
In essence, we need to provide a basis for saying each of the items is valid and will ensure we meet the requirements.

C. Equipment approval may be through calibration of settings and/or by producing a test piece and having it validated (i.e., sending the test piece out for testing).

D. Personnel qualifications can be achieved through an internally established testing process that coincides with methods used for equipment approval. When this is not the case, industry-related certifications tend to be the methods used.

E. Methods are the types of processes employed, the equipment needed, and the series of events sequenced. Procedures are the documents developed to address these issues, ensuring we have the information needed to consistently apply the methods.

F. Records need to be maintained showing the methods and equipment used and the people using those methods and equipment are qualified. We make sure those records are included in the records section of the Master Control Plan (embedded in Document & Records Control).

G. Revalidation needs to be performed within a timeframe allowing us to prove the methods, equipment, and people involved are still capable. While we get to set the timeframe, we need to make sure we have systems in place to see it through. These items can be added to the maintenance schedule, calibration schedule, or can be maintained by the affected manager.

 

NOTES:
1. Management utilizes the following sources of information to assess the need for additional resources and to determine the types of resources needed to enhance customer satisfaction by meeting customer requirements:
- Customer-Related Processes, - growth projections, - preventive/corrective actions,
- area management insight, and - quality/delivery issues.
2. Informing upper management of a need is typically verbal, but may be a memo or plan (see page 1) justifying the need, if deemed necessary. The process stops here if management says "no." If considered to be a capital expenditure, executive management would validate the need.
3. CRITERIA:
- Can someone already here meet the need? - Can we afford to move someone here without sacrificing our existing process?
4. Moving internal human resources may or may not require replacement. If replacement is needed, complete the process.
5. CRITERIA:
- Are we going to use a temporary agency to fill the need?
If yes, follow the connector to Purchasing. This is where we make sure the temporary agency is an approved vendor.
6. Hired employees are located by and employed through:
- word of mouth - walk-ins - employee referrals - temp-to-hire - advertising
Once the need is met, identify and provide training per the Training procedure. This procedure also addresses responsibility and authority.
7. Purchasing activities are typically accomplished by following the Purchasing procedure. However, where arrangements exist, we may simply be invoiced by a Temp Agency based upon the terms of the contract noting the number of hours their Temporary worked. Remember to follow the Training procedure, if we are bringing in a temporary employee or implementing additional equipment.
8. Don't forget about the considerations included throughout this document when introducing new equipment, facilities, or processes.
9. All maintenance activities are facilitated by area management with schedules maintained. When service agreements are involved, make sure the service provider is listed as an approved vendor (see Purchasing) if the service affects product quality or delivery.

Virus Software and System Backup Plan:
Pi-Co has established a solid system back up and protection plan.
- Daily backups are performed on all network stored data.
- Virus software is installed on each machine to scan newly introduced files and incoming email.
- Automated network updates, with computers not currently on being updated when they connect to the network.

 

DEFINITIONS:
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.