Att_0012_-_PCCI_Requirements_Clarification.doc

PROCESS CAPABILITY, CONTROL & IMPROVEMENT (PCCI) REQUIREMENTS CLARIFICATION

NOTE: This PCCI document’s content, in its entirety, is provided solely for REFERENCE and CLARIFICATION PURPOSES ONLY - it is not, nor is it intended to be, contractually binding. Accordingly, the information contained within the PCCI Clarification document is expressly not, nor shall it be construed to be, incorporated either directly or by reference into the terms of the PCCI Requirements itself nor into the terms and conditions of any underlying contract which contains the PCCI Requirement. This document is arranged in a manner such that the language of the requirement is enclosed in a box underneath the paragraph reference, followed by the clarifying narrative directly below.

Paragraph a.

Process Control involves ensuring a process is predictable, stable, and consistently operating at the target level of performance with only normal variation to maintain the desired output. Types of process control systems may include, but not limited to, Statistical Process Control (SPC) (such as x bar & r, run charts, etc.); visual, optical, camera or laser control sensors; specialized/built-in manufacturing/machining controls (e.g., CNC and robotic); instrumentation control systems (e.g., temperature and humidity controls), mistake proofing (e.g., hard stops), and many other numerous systems.

PCCI requirements does not mandate the use of SPC unless specifically stated in paragraph g of the requirement. Statistical methods are the preferred method of process control and is considered a best practice; however, there are many methods to monitor and control a process and these requirements were developed to allow use of any method that can be supported by objective evidence.

The Contractor will submit a Process Control Plan (PCP) as stipulated in DD1423. Once approved, the Government expects the Contractor to follow their own PCP – the Government may elect to withhold acceptance of product if there is evidence of noncompliance with the approved PCP.

Paragraph b.

This paragraph provides three (3) mutually exclusive options for the required Characteristics for Process Control (CFPC) that need to be addressed by the Contractor. One of these options will be selected by the Government and provided to the Contractor as part of the tailored requirements.

Option b(1)

In general, this option is selected when the Government has a high degree of confidence in the accuracy and completeness of the TDP such as firm fixed price contracts. The Contractor is expected to accept the Government selected characteristics in total when planning and implementing the requirements of PCCI. Either sub-option (1.1) or (1.2) will be selected by the Government, depending on where the CFPCs can be found.

Option b(2)

In general, this option is selected when the Government does not own or maintain the entire TDP. This can include performance based contracts where the specification is owned by the Government while the drawing package is owned by the Contractor. In such a case, it is assumed the Contractor has greater knowledge of their CFPCs. If option b(2) is checked, the Contractor must determine the CFPCs using an in-depth review and analysis. The Contractor will fulfill this requirement by providing all of the CFPC with objective evidence to the Government for review and acceptance. Each CFPC will be clearly identified and explained. The Government may identify additional CFPCs deemed necessary in paragraph g (e.g. interface control features, etc.).

Option b(3)

This option is selected when the Government wants to partner with the Contractor to identify the optimal set of CFPCs. This set of CFPC is specific for the procured item as well as the manufacturing system used. The focus of the analysis is safety, performance in terms of customer’s requirements and final cost impact of the features and processes. The basis for the analysis will be a systematic approach connecting Warfighter requirements to design features and process capabilities. In paragraph g, the Government will provide a set of requirements to allow Contractors to bid the tasks therein as part of the proposal process.

Paragraph c.

These requirements are applicable to the prime Contractor. It is the responsibility of the prime Contractor to apply these requirements to sub-Contractors at any and all levels of manufacturing processes that affect CFPCs. The application of these requirements is subject to Government review. It is important to note that all of the stated requirements, with the exception of the process flow chart, only apply to those processes that affect the identified CFPCs.

Process flow charts of the production process begin with the receiving of components or materials from Contractors and continues until the final product is packaged, labeled and shipped. The flow chart should incorporate every process and action which is directly or indirectly a part of producing the product. The more detailed the flow chart, the more likely potential failures in the process can be captured and prevented. The flow chart submission must be clear, complete and understandable to someone not familiar with the product or process. The use of industry standard flow charting techniques is recommended. All non-standard symbology should be clearly defined.

A PFMEA assists in the analysis of manufacturing and assembly processes. PFMEAs focus on potential product failure modes that result from manufacturing or assembly process deficiencies and the ability to detect the deficiencies prior to product delivery. Outputs from a PFMEA include recommended corrective actions and process modifications to eliminate the causes of process failures, or reduce the frequency of their occurrence to an acceptable level, and improve the defect detection capability of the manufacturing process. The PFMEA should be created using the flow chart to capture all processes involved that affect CFPCs. The PFMEA can be used to down-select those top few processes to be placed under process control by ranking using the calculated RPN values. The ones with the highest RPNs will pose the most amount of risk to a particular CFPC.

Process capability studies are fundamental to the understanding and control of all processes creating the product. Every process that affects CFPCs should attain acceptable levels of control. The level of control should be ascertained initially by careful measurement and analysis of the data to establish acceptable process capability (Cpk) levels. A good understanding of all possible influences should be considered and included in the PFMEA and control plan Measurement System Analysis (MSA) should be conducted on appropriate manufacturing and inspection processes where bias, linearity, stability, repeatability and reproducibility is suspected to be major factor in the accuracy or precision of the measurements. It is important to determine the possible individual effects due to variability in measurement equipment, methods, operators and other factors with potential to affect the outcome of any identified CFPC. The results of the MSA studies can impact process capability or detection levels especially in highly operator dependent processes. Operator dependent processes should be given special attention in detailing procedures and standards to minimize variation and increase control. Operator dependent processes should be eliminated where possible and tightly monitored and controlled when other alternatives are not practical.

Paragraph d.

The PCP is intended to be the unifying document that contain all of the process control activities and elements outlined in the PCCI requirements. All aspects controlling the production processes (as related to CFPCs) should be addressed in this document. The PCP is to be created by incorporation of the results of the in depth analyses required by paragraph c and all potential actions that affect product realization to be taken during the production of the product including:

· Process flow charts

· PFMEAs

· Process capability studies

· MSA studies

· Process control methods and tools:

· Process and inspection equipment

· Process Plan of Action (PPOA) for out of control conditions

· Process capability at Contractor stated production rate

Unless tailored, the acceptable (and capable) Cpk is as stated in para d. is at least 2.00 for Critical characteristics, 1.33 for all other CFPCs. If these stated values are not met and no longer being maintained, the Contractor should notify the Government. Any other actions / steps should be taken as necessary as stated in the approved PCP.

Paragraph e.

d

Application of this requirement is intended to support the implementation of MIL-STD-1916. Alternate methods of acceptance inspection and test requirements, including but not limited to reduction in sample sizes, may be proposed in accordance with MIL-STD-1916 as stated in the Foreword, paragraph 4.1 (general) and 5.1 (detail) of MIL-STD-1916. The data resulting from implementation of PCCI may be used to demonstrate the stability and capability requirements for alternate methods of acceptance inspection and test under the provisions of MIL-STD-1916.

Paragraph f.

Application of the above paragraph is intended to support and complement ISO 9001 and MIL-STD-1916. Corrective Action Requests (CAR) and Requests for Variance (RFV) should be looked at as opportunities for continuous improvement. The objective of the requirements in this paragraph is to ensure when opportunities for continuous improvement are identified they are documented, the PCP is reviewed for the potential addition of new CFPC, and process control techniques are applied that addresses how the Contractor will prevent future product non-conformances. These non-conformances may result from new failure modes or currently identified ones with CFPC that lack the appropriate process control once highlighted by a CAR or RFV. CARs written by Prime Contractors against their sub-Contractors for product non-conformance or RFVs are of interest as well. The Contractor’s PCP should be updated with the findings associated with the CAR or RFV (e.g. root cause analysis, corrective actions taken, etc.) and submitted to the Government. If updated PCPs submitted to the Government for review do not adequately address the CAR and/or RFV, the Government reserves the right to withhold acceptance of product until the plan is approved.

Paragraph g.

Detailed information is added to this paragraph only when box (1.1), (2) or (3) in paragraph b is checked. Listing of CFPCs and/or any additional requirements and remarks can be added in the section by the Government. All information added to this section is considered an official part of the PCCI requirements and should be construed as contractually binding.

a. The Contractor shall establish a Process Control System that includes, but is not limited to, procedures, systems and software. This Process Control System shall complement the requirements of an ISO 9001 or equivalent Quality Management System as well as all contract quality requirements. Statistical Process Control (SPC), when utilized, shall be implemented in accordance with ISO 11462-1 and ANSI/ASQC B1, B2, and B3 or equivalent. A Process Control Plan (PCP), which describes actions and methods to assure production processes are in a state of control, shall be submitted to the Government for review and approval as stipulated on DD Form 1423. Demonstration of process capability in accordance with the approved PCP shall be accomplished prior to or at first article (if required) or prior to start of production. The Government reserves the right to withhold acceptance of product when there is evidence of noncompliance to the PCP. Should a finding of noncompliance to the PCP be made, a corrective action plan shall be submitted to the Government for approval.

b. Characteristics for process control (CFPC) are as follows:

(1) CFPCs are features whose variation have a significant effect on product fit, form, function, performance, service life or producibility, that require specific actions for the purpose of controlling variation. CFPCs result from an in depth Government-only review and analysis as specified in Technical Data Package (TDP) documentation as required below:

[ ] (1.1) Government selected list, see paragraph g below

[ ] (1.2) As listed key characteristics

[ ] (2) CFPCs are features whose variation have a significant effect on product fit, form, function, performance, service life or producibility, that require specific actions for the purpose of controlling variation. CFPCs shall be determined using an in-depth Contractor review and analysis as specified in the PCP documentation. The Government reserves the right to identify any CFPCs as well as any additional characteristics identified in paragraph g.

[ ] (3) CFPCs are features within a product, subassembly, part and process whose variation from nominal (i.e., target value) significantly impacts safety, performance in terms of customer’s requirements, or final cost of a product. Special controls should be applied where the cost of variation justifies the cost of control. These shall be developed from an in depth Government-Contractor review and analysis of design as specified in paragraph g below.

c. The Contractor’s analysis shall include processes and operations under the control of the prime Contractor and those under the control of sub-Contractor including subtier suppliers. The Contractor shall create a process flow chart for the entire process (including manufacturing, inspection and material handling) and also perform a Process Failure Modes and Effects Analysis (PFMEA) for processes identified on the process flow chart affecting CFPCs. The Contractor shall identify, define and document specific controls applicable for each process and operation that affects all CFPCs. The Contractor shall: (a) conduct process capability studies on all process and operation parameters affecting CFPCs; (b) verify that all automated inspection equipment used to validate process capability has been properly calibrated and certified; and (c) conduct Measurement System Analysis (MSA) studies on all applicable corresponding measurement systems utilized to monitor process capability.

d. The Contractor shall prepare and implement a PCP. The PCP shall be based upon and include the process flow chart, PFMEA, process capability studies and MSA studies for all process and operation parameters affecting CFPCs. For each CFPC, the PCP shall describe the entire process (including manufacturing, inspection and material handling), control methods and action plans for all out of control conditions and process capability at the stated production rates. When utilizing statistical methods, a process capability index such as Cpk shall be calculated. A CFPC shall be considered to have an acceptable (and capable) process if it has a Cpk of at least 2.00 for Critical characteristics, 1.33 for all other CFPCs, or as stated as follows: _______. The Contractor shall notify the Government when the minimum process capability values (Cpk) of 2.00 for Critical characteristics and 1.33 for all other CFPCs, or the alternative established minimum Cpk values, are no longer being maintained.

e. In accordance with MIL-STD-1916 the Contractor may request, in writing, that alternate methods of acceptance be evaluated once the processes and applicable operation parameters have been demonstrated to be both stable and capable. Any alternate methods may not be implemented until approved by the Contracting Officer.

f. Corrective Action Requests (CAR) and Requests for Variance (RFV) generated for identification of product nonconformances shall result in an evaluation of the PCP. The evaluation shall consider addition of new CFPCs to the contractually required process control list and require implementation of actions per paragraphs (c) and (d) above with submittal to the Contracting Officer for Government approval. If the CARs and RFVs are related to characteristics, processes and / or operations already identified in the PCP, then those actions required by paragraphs (c) and (d) shall be reassessed and submitted to the Contracting Officer for Government approval. The Government reserves the right to withhold acceptance of product until the revised PCP is approved by the Government.

g. If box b (1.1), b(2) or b(3) are checked above, the selected characteristics and applicable tools, techniques, control methods or method of analysis to obtain these are specified as follows: