PRODUCT / PROCESS VALIDATION

1.0 SCOPE & RESPONSIBILITIES

1.1 The purpose of this procedure is to provide instructions / requirements for performing product / process
validations.

1.2 This procedure applies to all new products, special manufacturing processes where the output cannot
be fully verified by subsequent inspection and test and equipment relocation. Normal manufacturing
processes where verification is not included in routine processing also require validation.

1.3 The Senior Quality Engineer has overall responsibility for this procedure.

2.0 DEFINITIONS

2.1 Process – A process is defined as any distinct operation that receives input and results in an output at
any stage of the overall manufacturing process for producing a finished device or component.

2.2 Process Validation – Process Validation establishes by objective evidence that a process will
consistently produces a result or product meeting its predetermined specifications.

2.3 Process Verification (PVE) – Process verification (PVE) establishes by the use of statistical tools to
estimate process stability & consistency to show that a process will consistently produced a result or
product meeting its predetermined specifications.

2.4 Verification – the act of reviewing, inspecting, testing, etc. to establish and document that a product,
service, or system meets the regulatory, standard, or specification requirements.

3.0 CUSTOMER REQUIREMENTS

3.1 Should the validation requirements be specified by the customer, these requirements shall be
reviewed & taken into consideration when process validation / PVE requirements are decided.

3.2 As a minimum, the validation / PVE process carried out shall satisfy the regulatory requirements for the
target market.

4.0 DOCUMENT CONTROL

4.1 All documents related to validation activities that require signed approval (e.g. protocols, close out
reports, IQ reports etc) shall be controlled by issue level, dated & approved accordingly.

5.0 PROTOCOLS

5.1 For any validation activity, a protocol shall be raised detailing the method of validation, including all
requirements and acceptance criteria for each stage.

5.2 Validation protocols must be approved by a minimum of the Quality Engineer, Business Unit Manager,
Engineering department and / or the Project Leader. Further approvals may be required including
customer representative(s) where appropriate.

5.3 Protocols must be fully approved prior to the commencement of any validation activity.

5.4 Where required, Regulatory Affairs shall review the validation protocols to ensure they meet the
required standard.

6.0 GENERIC DOCUMENTS

6.1 Prior to commencement of any validation activity, the following activities shall be carried out, recorded,
reviewed & approved and completed documentation will be included with the closeout reports:

6.1.1 Failure Modes & Effects analysis (FMEA)

6.1.1.1 Identify potential failures at each operation as recorded on the route card / process
instructions, potential root causes and numerical risk assessments (RPN)
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 6.1.1.2 The FMEA shall include a key showing which potential failure modes require action
as per their individual RPN scores.

6.1.1.3 All required actions shall be closed out or remedial action plans put in place prior to
proceeding with validation activities.

6.1.2 Process control Plan

6.1.2.1 Each operation shall be identified separately as recorded on the route card / process
instructions.

6.1.2.2 For each operation, every product feature / process characteristic that is measured
during operation shall be identified along with methods of inspection and sample
plan.

6.1.2.3 Rework / rectification requirements shall be documented for each control item.

6.1.3 Process Flow

6.1.3.1 The process flow shall be documented, including all applicable rectification / rework
cycles, identifying each process as identified on the route card / process
instructions.

6.1.4 Contact Materials

6.1.4.1 All contact materials shall be recorded & copies of data cards taken for inclusion
with the final close out report.

7.0 METHODS

7.1 Dependent on product configuration, order forecasts, engineering requirements or other

considerations, the quality department shall determine the validation method to be used and the
requirements thereof.

7.2 There are 3 methods of product / process validation typically used; IQ/OQ/PQ (FDA standard),
Process Verification (PVE) or Sample Submission (product validation only).

7.3 IQ OQ PQ

7.3.1 ‘IQ OQ PQ’ consists of three related stages of validation; Installation Qualification (IQ),
Operational Qualification (OQ) and Performance Qualification (PQ)

7.3.2 Installation Qualification (IQ) – Establishing by objective evidence that all key aspects of the
process, process equipment and ancillary system installation adhere to the approved design
criteria and that the recommendations of the manufacturer of the equipment are suitably
considered.
7.3.2.1 Each piece of equipment used in the product manufacture / process shall be
identified & installation qualification performed.

7.3.2.2 Installation qualification shall include as a minimum, a review of the following

aspects: process risk assessments, calibration, standard operating procedures,
preventive maintenance, environmental / H&S factors and operator training. Other
requirements will also be listed in the validation protocol if appropriate.

7.3.2.3 Results of the installation qualification shall be recorded along with appropriate
objective evidence in the IQ report. Reference shall be made to individual IQ reports
in the final validation close out report.

7.3.3 Operational Qualification (OQ) – Establishing by objective evidence, parameters which

result in product that meets all predetermined requirements, including worst case conditions.

7.3.3.1 Prior to OQ stage of validation, the following must be completed / verified:

 Approved Installation Qualification (IQ) report(s)
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  Equipment calibration
 Quality Systems Procedures / SOPs
 Raw material specifications
 Product specifications
 Verification of approved supplier (s) for key materials
 Environmental requirements or specifications

7.3.3.2 The protocol develops a detailed description of the tasks to be performed and the
expected outputs to include the following, as a minimum. The description identifies,
“who does what” and, “How it will be done” with sufficient detail to ensure
consistency of execution. It includes the following:

7.3.3.3 Describes production runs; nominal and “worst case” conditions, or production runs
for each size of product family to be manufactured.

7.3.3.4 Develops the required form for data collection, to include, what is measured and
recorded with respect to the process parameters and product characteristics.

7.3.3.5 The following criteria are to be met for acceptance:

7.3.3.5.1 The protocol states the acceptance criteria for the successful
completion of the OQ.

7.3.3.5.2 Records must be complete, accurate and reviewed.

7.3.3.5.3 Product specifications are met, at worst case conditions, in accordance

with the specified acceptance – sampling plan.

7.3.4 Performance Qualification (PQ) – Establishing by objective evidence that the process, under
anticipated conditions, consistently produces a product which meets all predetermined
requirements.

7.3.4.1 The purpose of this activity is to establish confidence through appropriate testing
that the finished product produced by a process meets all release requirements for
functionality and safety. The protocol shall define the products, equipment, and
processes involved in the Performance Qualification (PQ)

7.3.4.2 Installation Qualification and Operational Qualification activities must be completed

& approved prior to commencement of PQ activities.
7.3.4.3 PQ batches must be representative of planned production conditions, including
inspection sampling, operation instructions etc.

7.3.4.4 3 batches of “challenge sizes” (typically largest & smallest sizes in product range or
products whose configuration presents the worst conditions for the process) shall be
manufactured on separate production shifts.

7.3.4.5 The following criteria is to be met for acceptance:

7.3.4.5.1 The protocol states the acceptance criteria for the successful
completion of the PQ.

7.3.4.5.2 Records must be complete, accurate and reviewed.

7.3.4.5.3 Product specifications are met in accordance with the specified

acceptance – sampling plan.

7.3.5 IQ OQ PQ Close Out

7.3.5.1 Reference shall be made to IQ reports, OQ & PQ results and acceptance criteria in
the IQ OQ PQ close out report.

7.3.5.2 Close out reports shall be reviewed & signed by a minimum of quality engineer,
business unit manager & engineering and/or project leader. Other signatories may
be required such as customer representative etc.
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 7.3.5.3 Copies of all reports, objective evidence etc shall be kept on file by the quality
department in line with current document retention policies.

7.4 Process Verification (PVE)

7.4.1 Process verification demonstrates process stability / repeatability through the used of
statistical techniques.

7.4.2 Prior to commencement of PVE activities, the process flow, contact materials, FMEA & control
plan documents must be assembled & reviewed for acceptance.

7.4.3 Measurement systems analysis (MSA)

7.4.3.1 Measurement systems analysis shall be performed on all critical features where
variable gauging is used at any point in the manufacturing process.

7.4.3.2 MSA shall be conducted by the use of Gauge Repeatability & Reproducibility studies
(Gauge R&R).

7.4.3.3 Gauge R&R shall be performed on a minimum of 5 parts, measured 3 times over by
3 separate operators & the results processed using an appropriate statistical
analysis package.

7.4.3.4 The resulting Gauge R&R % (of total tolerance) shall be no greater than 30% (target
ideal <10%).
7.4.3.5 Any gauge method that gives unacceptable results must be changed / modified and
the Gauge R&R study for that feature re-started.

7.4.4 Sample Manufacturing

7.4.4.1 A minimum of 40 off pieces shall be manufactured / processed for a mid-range

product.

7.4.4.2 Sample batches (typically 10 off) of every other size in the product range shall be
manufactured / processed.

7.4.4.3 All parts shall be subjected to 100% dimensional inspection.

7.4.5 Process capability analysis

7.4.5.1 The dimensional results for the 40 off batch shall be analysed for process capability
on critical features (Cpk)
7.4.5.2 The Cpk value for every feature must be a minimum of 1.33.

7.4.5.3 If the Cpk results of any feature fall in the range 1.00 – 1.32, validation may continue
however these features must be 100% inspected on all subsequent batches until
process changes are made and shown to achieve the minimum 1.33 Cpk.

7.4.5.4 Should any features fail process capability (<1.00 Cpk), the root cause shall be
determined, the process shall be improved and a further 40 off batch launched to
prove out process capability using the method described above.

7.4.6 PVE / PPAP Close out

7.4.6.1 Process flow, contact materials listing, FMEA, Control Plan, MSA results,
Dimensional inspection results, and process capability analysis shall all be reviewed
and signed off by a minimum of the quality department and engineering.

7.4.6.2 Copies of all reports, objective evidence etc shall be kept on file by the quality
department in line with current document retention policies.

7.5 Sample Submission (Product verification)

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 7.5.1 In the case of very low production forecasts, product validation along IQ OQ PQ or PVE routes
may not be required or may not be feasible, sample submission may be used in its place.

7.5.2 The customer must give written approval to use sample submission to show process produces
confirming product.

7.5.3 Proof batches shall be manufactured for each size in the product range.

7.5.4 Each batch shall have at least one piece measured 100% on all features shown on the
drawing print.

7.5.5 All other pieces shall be 100% inspected on critical features.

7.5.6 The results of all dimensional results shall be reviewed internally & sent to the customer for
approval. Only with written customer approval shall the product range be released for
manufacture.

8.0 DEVIATIONS

8.1 Deviations from the validation protocol and/or discrepancies related to the product / process validation
which occur during the execution of the validation activities, will be documented on individual deviation
forms as part of final report appendices.

8.2 Errors or failures (including dimensional failures) must also be documented on individual deviation
forms and must undergo the formal corrective action process. All deviations will be summarised in the
final report. Deviations raised must be closed with all required signatures before any actions are
carried out.

8.3 If a deviation from the protocol occurs, if information or part of the equipment/system is missing, a
deviation must be generated. The deviation number assigned can be referenced in the relevant check
box or report section.

8.4 Any deviations noted will be assessed for potential impact on the validation study.

8.5 Any deviations that occur must be addressed at the time of occurrence and not at the time of writing
the report.

8.6 All critical deviations must be satisfactorily closed out prior to proceeding to any subsequent stages of
validation.

9.0 PROCESS EQUIVALENCE

9.1 Where a product validation exists for an equivalent or similar type of part and process equivalency can
be proved, reduced validation requirements may be permitted.

9.2 In order to show process equivalency a rationale must be drawn up giving objective evidence for
process equivalency and proposals for reduced validation requirements. The rationale must be
approved by a minimum of quality dept, business unit manager and engineering. Regulatory affairs
and / or customer representative may be required to review & approve also.

9.3 A copy of the process equivalency rationale must be included in the validation close out report and
referenced in the validation protocol.

10.0 SAMPLE SIZES

10.1 Where applicable, sample sizes used for product & process validations should be derived from
standard sampling / test plans such as BS6001 / BS6002 / ISO2859. Where sample sizes deviate from
such standards, note should be made in the validation protocol and approved accordingly.

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