NQA MANAGEMENT SYSTEMS RECERTIFICATION (TRANSITION ...€¦ · John Early. Process Owner(s): NQA...

NQA MANAGEMENT SYSTEMS

RECERTIFICATION (TRANSITION)

PROCESS AUDIT REPORT

National Flexible Ltd

238615

24 October 2017

ISO 9001:2015

John Early

0797 401 4166

[email protected]

Version 18 of 22 September 2017

Audit Report Part A - Executive Summary

Client Information

Primary

Contact:

Caroline Clay Contact Tel: 01274 685 566

Address: 2 Battlefield View, Birkenshaw

Bradford, West Yorkshire

BD11 2PT

Contact E-Mail: [email protected]

Billing Contact: Carol Burdett Billing Tel: 01274 685 566

Billing E-Mail: [email protected]

System integration (integrated audits only): None

Additional information on integration if

required:

Certificate Valid Until Date(s): 14 September 2018

Required changes to EAC or NQA Codes

applied:

(See NQA Certificate of EQM for details)

No Changes Required

At this location Across all locations (Multisite)

Total Employees 46

Repetitive or parallel workers

Energy Engaged Employees

Energy Consumption

Number of Energy Uses

Number of Energy Sources

Energy data only applicable for ISO 50001 audits. Further guidance available in ASR 47 : 2.1

The date of the next audit is: To be confirmed



Audit Information

Audit Duration (in person-days): 1½

This visit was: Satisfactory. Registration to ISO 9001:2015 is recommended.

Scope of certification:

The supply and conversion of food grade packaging, films and sacks to the food and packaging industry.

As certificate 9255, valid until 14 September 2018.

This scope is confirmed as appropriate.

Confirmation that audit objectives have been fulfilled: All objectives met

If no, which objectives have not been met:

NQA Audit Team Client Position Attendance

Lead Assessor John Early Barry Twigg CEO Opening and Closing

NQA Observer Carol Burdett Commercial Director Opening and Closing

Caroline Clay QA Manager Opening and Closing

Scott McEvoy Technical Engineer Opening and Closing

Toni Leach QA Assistant Opening and Closing

Details of Changes

Type of action or change required Action Required Notes

Client Name Change

Change of Address

Scope Change

Contact Change

Number of Employees Change X Employees now 46

Major NCs Raised

Special Visit Recommended

Other



Executive Summary

Scope of registration

The supply and conversion of food grade packaging, films and sacks to the food and packaging industry.

As certificate 9255, valid until 14 September 2017.

Description of the organisation, its context, leadership and commitment

The company is a specialist supplier and converter of food grade packaging.

It defines its: Business environment: UK Mainland.

Markets: Food manufacturers and contract packagers.

Suppliers: Specialist polymer film manufacturers and printers.

Competitors: Board review (commercially confidential).

Leadership and commitment are demonstrated through the provision of resources for the NQA audit.

Positive observations and details of improvements noted

Very focused effort in upgrading the quality system to ISO 9001:2015.

The personal involvement of the company executive in the audit proceedings was commendable.

Excellent customer emphasis evident.

Customer commendations and repeat orders are the norm.

Minimal customer complaints evident in last twelve-months.

Brief details of any nonconformities, particularly any trends detected

No findings have been raised at this visit.

No trends are apparent over the last three year period.

Controls in respect of the processes sampled

Operational process controls provide for integrity and accuracy of service to customer requirements.

Conclusion as to the extent of conformity with the audit standard

As observed, the quality management system can be considered to be compliant with ISO 9001:2015.

Overall effectiveness of the management system

The quality management system is effective and supports the business activity of the organization.

Capability of the management system to meet applicable requirements and expected outcomes

The organization’s quality management system is configured to offer continual operational control in

achieving the business objectives.

Statutory and legal requirements are considered met.

Internal audit

Internal quality audits are aligned to the requirement of the organization and are effective.

Continued overleaf



Executive summary (continued)

Management review

Management review is aligned to the requirements of ISO 9001:2015 and the organization. It is addressed

by senior management.

Conclusion

Satisfactory ISO 9001:2015 recertification / transition visit.

No concerns.

No additional reassessment visit is required.

Registration to ISO 9001:2015 is recommended.

The date of the next visit

Has not been agreed.

No findings were raised.

The following action should be taken by the client:

No action required.

Major

NCs 0 Minor NCs 0 OFIs 0 AoCs 0

No conflict of interest exists between the Auditor(s) and the client, and there is no situation known to

them that presents themselves, or NQA, with a potential conflict of interest in respect to the audit

undertaken.

Confirmed


Audit Report Part B – Audit Report

Audit Findings

Ref

No.

Clause

No.

Details of finding(s) raised.

Reference documents, records, etc. as applicable

Type (Major NC, Minor

NC, OFI or AoC)

Intentionally blank

Note: Responses to findings must be sent to [email protected] within the stated timeframes

Management system performance; such as trends in audit findings that require further investigation at

the next recertification audit

Mandatory completion at the Head Office Audit of Surveillance Year 2

A very focused and carefully applied quality management system.

No negative trends are apparent over the last three year period.

Closure of Findings from Previous Audits

Ref

No. Detail of finding and client action

Outcome (Closed or

Escalated)

The single finding (administrative NC) raised in the last report relating to ISO

9001:2015 has been fully resolved through this recertification / transition visit.

Closed



Opening/Closing Meetings:

Opening and closing meetings were performed in accordance with NQA Form 335. The objective of the audit

was to confirm that the management system had been established and implemented in accordance with the

requirements of the audit standard.



Process/audit area: (QMS) Context of the organization 4

Auditee(s): Caroline Clay. Carol Burdett. Scott McEvoy. Toni Leach.

Caroline Clay.

John Early.

Process Owner(s):

NQA Assessor:

Evidence to support audit conclusion:

Empirical process requirements:

• Determination of the business environment and opportunity.

• Determination of customer requirements.

• Establishment of business scope.

• Generation of a quality management system to support the business activity.

Process compliance detail:

The organizational framework has been established to serve the business activity:

The company is a specialist engineering company.

It defines its:

Business environment: UK Mainland.

Markets: Food manufacturers and contract packagers.

Suppliers: Specialist polymer film manufacturers and printers.

Competitors: Board review (commercially confidential).

Customer requirements have been determined as:

Requirement for safe, legal food contact packaging to BRC standard.

This concurs with the scope of registration.

The scope of registration of the quality management system is specified as:

The supply and conversion of food grade packaging, films and sacks to the food and packaging

industry.

As certificate 9255.

This concurs with the scope stated in the Quality Manual, section Scope.

Quality management system comprises:

Documented quality policy.

Documented quality objectives.

Documented quality manual.

Documented quality procedures.

Process maps. For example:

HACCP Plan, section 5.3 ‘Process Flow Chart’.

Technical support documentation, including supplier’s technical data.

Other documented information, including records.

Conclusion of the overall effectiveness of the process:

Process / audit area satisfactory.

The context of the organization has been suitably established and adequately defined.



Process/audit area: (QMS) Leadership 5


Caroline Clay.

John Early.

Process Owner(s):

NQA Assessor:



• Demonstration of leadership and commitment by the executive.

• Determination of risk.

• Provision of means to determine the applicable legislation.

• Establishment of a defined quality policy.

• Determination of organizational roles, responsibilities and authorities.

• Appointment of quality management system facilitator(s).


Leadership and commitment by top management demonstrated by:

Authorization et cetera of the quality management system by:

George Slack, Managing Director.

Attendance at the visit opening and closing meetings by:

Company executive and senior management.

Involvement in management review by George Slack, Managing Director.

Promotion of the process approach and risk-based thinking, as detailed herein.

Issue of new documented risk based SWOT assessment process format.

Provision of resource for the QMS as detailed herein.

Effective internal communication of the importance of effective quality management.

Provision for improvement.

Meeting customer, statutory and regulatory requirements. Examples:

Customer requirements: See (QMS) Context of the organization 4.

Computer based legislation and industry requirement listing including:

Food Safety Act 1990, SI 16. (Plus amendments.)

The Food Safety and Hygiene (England) Regulations 2013, SI 2996.

The Food Safety and Hygiene (England) (Amendment) Regulations 2016, SI 868.

Determination and resolution of risks and opportunities relating to product (service) conformity:

Addressed via ‘SWOT Analyses’.

See also (QMS) Planning 6 - Risk analysis.

Customer satisfaction review: See (QMS) Performance evaluation 9.

Establishment and dissemination of a defined quality policy:

Documented quality policy, issue 6, 12 September 2017.

Structure and content confirmed re:

Suitability to the purpose, context and strategic direction of the organization.

Provision of framework for setting quality objectives (Para 4).

Commits to: Satisfying applicable requirements (Para 7);

Continual improvement of the QMS (Para 7).

Authorisation by: George Slack, Managing Director.

Dissemination confirmed via:

Displayed on notice boards.

New employee induction.

Continued overleaf:



Process / Audit area: (QMS) Leadership 5 (continued)

Evidence to support the audit conclusion (continued):

Process compliance detail (continued):

Organizational roles, responsibilities and authorities:

Organization structure as depicted by SOP 016.1 ‘Organogram’, issue 14.

Responsibility & authority defined by reference to job descriptions & contracts of employment, as

maintained by the HR function.

Dissemination of same is by management with provision for induction for new starters.

Management system facilitators (internally termed Quality Assurance Manager):

Principal: Caroline Clay, Quality Assurance Manager.

Supported by: Toni Leach, Quality Assurance Assistant.



Leadership is established and demonstrated.



Process/audit area: (QMS) Planning 6


Caroline Clay.

John Early.

Process Owner(s):

NQA Assessor:



• Execution of an business risk analysis relating to business characteristics.

• Establishment of quality objectives.

• Provision for future review of the established quality objectives.

• Management of the planning of change.


Risk analysis - See also (QMS) Leadership 5:

On-going SWOT analyses. Last: 29 July 2017 (weekend meeting).

Next due: End of October 2017.

Strengths: Examples: Detailed Food Hygiene technical knowledge.

Commercially aware team

Provision of small scale training for customers.

Provision of business tours to customers.

Weaknesses: Example: Computer system conflicts. (Two systems in use.)

Opportunities: Example: Appointment of key customer champions.

(Top 60 customers now have customer champions.)

Threats: Example: Price fluctuations.

Brexit.

Quality objectives:

Setting of six KPI based quality objectives at management review.

Customer complaints. Target < 1.2 % of sales orders.

Maintain AA grade BRC certification.

Internal audits, on time to schedule.

Customer returns / rejections to be closed out within 28 days.

Workforce to be trained to level 2 food safety and HACCP fundamentals.

Zero product recalls.

Provision for consideration of quality objectives, at subsequent management review.

Planning of changes:

Changes to the QMS will be carried out in an appropriate and controlled manner.

ISO 9001:2015 system initiation originated at management meeting November 2016.

ISO 9001:2015 system completed July 2017.

Any future changes will be planned during management review.



Risk analysis is focused.

Quality objectives have been established.

Provision for planning of change is logical.



Process/audit area: (QMS) Support 7


Caroline Clay.

John Early.

Process Owner(s):

NQA Assessor:



• Determination and provision of adequate staffing level.

• Determination and provision of adequate infrastructure.

• Determination and provision of adequate environment for the business processes..

• Provision of suitable controls for quality monitoring and measuring equipment.

• Maintenance of the business knowledge management base.

• Provision of competent employees with suitable awareness and skills.

• Provide to the control of documented information, with specific reference to the:

Operation of an internal communication system.

Operation of an external communication system.


Staffing level determination:

Core workforce based on anticipated and actual production requirement.

Short term fluctuation managed via overtime.

Infrastructure needs are identified, provided and maintained on a cost effective basis.

These include buildings, workspace, associated utilities, process equipment,

warehouse space, hardware, software, and support services.

Close access to the motorway network.

Infrastructure improvements:

New office extension planned.

New storage extension planned.

Environment for the operation of processes:

The work environment is determined and managed in order to ensure products meet process

requirements.

Control of quality monitoring and measurement equipment:

Computer based calibration register, examples

Calibration record for: Lucid Scales.

Model: Lucid.

Serial number: 81784.

Cert: 25992.

Valid until: October 2017.

Calibrated 23 October 2017 (yesterday) awaiting certificate.

Calibration record for: Apex Scales.

Model: Apex Junior.

Serial number: 1126093.

Cert: 25996.

Valid until: October 2017.

Calibrated 23 October 2017 (yesterday) awaiting certificate.

(continued overleaf):



(QMS) Support 7

Evidence to support audit conclusion (continued):


Maintenance of the engineering knowledge management base supported by specialist skills sets.

Specialist skills:

Employee competency in food safety and BRC requirements.

Employee competence:

Training records for employees determining skills and competencies for:

Barry Twigg: CEO.

George Slack: Managing Director.

Carol Burdett: Commercial Director.

Caroline Clay: Quality Assurance Manager.

Toni Leach: Quality Assurance Assistant.

Scott McEvoy: Technical Engineer.

Kim Hartley: Area Sales Manager.

Jonathan Joy: Customer Champion.

Simon Bortoft: Production Supervisor.

Dave Harland: Production Operator.

Martin Taylor: Production Operator.

Tony Barker: Production Operator.

Showing competence, education, training, skills and experience.

Staff training plans as required (subject to annual review).

Dissemination and application of the quality policy - See (QMS) Leadership 5.

Dissemination and application of the quality objectives - See (QMS) Planning 6.

Internal communication:

Internal communications pathways established via the organisation chart.

External communication from interested parties:

Establishment, authorisation and application of an external communications system.

Controlled by: George Slack, Managing Director.

Example: No relevant external communications in last twelve-months.



Support is established and demonstrated.



Process/audit area: (QMS) Operation 8


Caroline Clay.

John Early.

Process Owner(s):

NQA Assessor:



• Establishment of process operation criteria re:

• Operational planning control.

• Sales order control.

• Design and development control.

• Outsourced process control.

• Procurement control.

• Production and service provision control.

• Release control.

• Nonconforming product / service control.


Operational planning and controls exercised over the product (service) activities are detailed in:

Process procedures:

SOP 05: Order Processing and Contract Review.

SOP 13: Customer Complaints and Control of Non-conformance.

Which in turn are supported by job specific work instructions (SOP 10 series). Together with

job specifications derived from risk assessments.

Customer communication:

Sales process:

Enquiry / quote / order system reviewed.

Discrete orders from established customers:

Customer: Bells of Lazonby Ltd.

Customer’s order: S006455.

Pick number: 1711010009.

Customer: Border Buscuits Ltd.

Customer’s order: 24425.


Customer: Park Cakes Ltd.

Customer’s order: 450039771.


Pick number format: YY MM DD plus 4 digit number.

There are no contractual post deliver activities.

Product is sold under the current conditions of sale.

Requirements for product:

Statutory / regulatory requirement to be fit for purpose and safe:

Determination of applicable customer, industry, legislative and BRC requirements.

Review of the requirements for products and services:

Changes to the requirements for products, subject to review of customer provided information.




(QMS) Operation 8



Design and development:

Layout generation is by skilled graphic designers. Note that the term ‘Design’ activity relates to Mac

based graphic design. Such is not formal design / development. It is an industry term for the

realisation and imposition of customer supplied artwork, concept or copy.

Graphic design activity:

Job number: 001_CW_PeanutBagsHelloFresh_C1. (Concept 1.)

Artwork code: 001_CW_PeanutBagsHelloFresh_V1. (Version 1.)

Customer: Chilli Wizards.

Product: Insane Ghost Pepper Peanuts.

Concept supply: Chilli Wizards.

Concept interpretation: National Flexible Graphic Designer.

Equipment used: Mac computers.

Control of externally provided processes, products and services:

External provider evaluation, selection and re-evaluation is by senior management.

Computer maintained approved supplier database. On-going maintenance.

Purchasing information:

Purchase order 4009729 to EK Pack GmbH for printed laminate film.

Corresponding PoD (delivery note): 61707623. GRN 4009729. (GRN = PO No).

Purchase order 4009674 to Mercury Packaging Ltd for printing and laminating of OPP film.

Corresponding PoD (delivery note): 121504. GRN 4009674. (GRN = PO No).

Purchase order 4009727 to Hatzopoulos SA for printed laminate film.

Corresponding PoD (delivery note): 59037139.1. GRN 4009727. (GRN = PO No).

Verification of purchased product:

GII consists of inspection for type, quantity and integrity, together with office reconciliation of PoD

with PO and issue of GRN (Goods Received Note).




(QMS) Operation 8



Core process: Film conversion.

Forward workload (commercially confidential).

Review of current production of cardboard boxes:

Recent activity:

Pick number: PO 1709050004.

Customer: Park Cakes Ltd.

Product: S2G245460PC oriented poly propylene film.

Batch No: 002103082.

Quantity: 550 kg (by weight).

To: Benchmark sample.

Operator: Tony Barker.

Pick number: PO 1709150014.

Customer: Border Biscuits Ltd.

Product: S2G25340BBS oriented poly propylene film.

Batch No: 002114817.

Quantity: 511.8 kg (by weight).

To: Benchmark sample.

Operator: Tony Barker.

General:

Property belonging to customers or external providers: Intellectual property and benchmark samples.

Preservation: Industry, customer, legislative and BRC standards apply.

Control of changes: By job specification issue, version, revision number as applicable.

Release of product: By final inspection by Production Management.

Control of nonconforming outputs:

Identification of NC.

C /A / Disposition: System is re-grade for another customer.


Operational process controls provide for:

Integrity and accuracy of technically and aesthetically excellent and product / service to customer

requirements.



Process/audit area: (QMS) Performance evaluation 9


Caroline Clay.

John Early.

Process Owner(s):

NQA Assessor:



• Monitoring, measurement, analysis and evaluation: Data acquisition and manipulation.

• Evaluation of Compliance.

• Internal audit.

• Management review.


Monitoring, measurement, analysis and evaluation:

MMAE data demonstrating conformity of product to requirements.

Example: Generation of MMAE data derived from sales.

KPIs are established.

Customer satisfaction:

National Flexible Customer Survey 2016.

Analysis and customer response: 97% achieved (94% in 2015).

Internal audits:

Internal audit programme 2017 completed.

Full system audit, 24 July 2017.

To requirement of ISO 9001:2015.

QMS audited.

Audit objectivity confirmed. Three findings (1 minor NC, 2 OFIs) raised.

Corrective actions: Two closed, one pending as per programme.

Auditor independence achieved. Three internal auditors utilized.

Corrective actions - See (QMS) Improvement 10

.

Management review:

Minutes of annual management review 22 August 2017.

QMS management review, carried out against ISO 9001:2015 (agenda items numbered).

Status of actions from previous MR 1 Monitoring and measurement results 7

Changes in external & internal issues 2 Audit results 8

Customer satisfaction and feedback 3 Performance of external providers 9

Quality objectives achievement 4 Adequacy of resources 10

Process performance and product conformity 5 Actions re risks and opportunities 11

NCs and corrective actions 6 Opportunities for improvement 12

Chaired by George Slack, Managing Director and attended by senior functionaries.

Next management review due 2018, Q3.



Performance evaluation is effective and facilitates continual improvement.



Process/audit area: (QMS) Improvement 10


Caroline Clay.

John Early.

Process Owner(s):

NQA Assessor:



• Control of quality nonconformities.

• Application of continual improvement.


Control of quality nonconformity and corrective action:

Identified by internal audit. Three findings (1 minor NC, 2 OFIs) raised.

Corrective actions: Two closed, one pending as per programme.

Product related. None in last twelve-months.

Corrective actions: Not applicable.

Customer complaints. Minimal complaints evident in the last twelve-months.

170 complaints evident, 99 are invalid.

This equals < 1.11% against orders, with Cost-of-Quality determined.

Corrective actions: 6 outstanding, remainder resolver.

Provision for annual review of nonconformities and corrective action, at management review.

Appraisal of corrective actions. As identified.

Continual improvement:

Risk / opportunity update:

Progressing at this stage in the recent update to ISO 9001:2105.

Note: SWOT analysis as part of the risk analysis strategy.

(See (QMS) Planning 6).

QMS modification / improvement.

Determined as suitable following the recent full alignment to ISO 9001:2015.



Quality findings identified with appropriate corrective action applied.

Quality management system modification to ISO 9001:2015 has been successfully achieved.



Use of Registration Marks and Logos

Use of Registration Mark (if used) is in accordance with the Rules of Registration N/A

NQA ISO 9001 logo utilised on website.

UKAS mark employed on website.

Note that the NQA / UKAS device is a superseded version.

Examples of the current NQA logos:

ISO 9001

ISO 9001 (UKAS Accredited) with ‘UKAS Tick and

Crown’

More information can be found at: https://www.nqa.com/en-gb/clients/logo-library

Our logos have recently been refreshed with a new design. This does NOT mean you need to change them, but

bear in mind for next time a change is due. The new designs can be downloaded from our website.

If there are inaccuracies, errors or queries regarding this report or audit findings, please

contact NQA Head Office on 0800 052 2424 within 5 working days of the closing meeting.

End of Audit


Audit Report Part C – Audit Plan

Client: National Flexible Ltd Audit Date/s:

To be confirmed

Audit Start Time:

As below Lead Assessor:

Team Member/s

John Early - TBC

Standard/s ISO 9001:2015 This plan relates to the

next: (audit type)

SURVEILLANCE

Date Time Location/Department/Function Auditor

TBC 9.00 am Opening meeting As above

Executive interface

Review of NQA reports

Admin

10.00 am 4 - Context of the organization. All parts 4.1 to 4.4.

5 - Leadership. All parts 5.1 to 5.3.

11.00 am 6 - Planning. All parts 6.1 to 6.2.

7 – Support. All parts 7.1 to 7.5.

Noon 8 – Operation. All parts 8.1 to 8.7.

Functional areas:

Commercial office.

Graphic design office.

Production area – Film conversion.

3.00 pm 9 - Performance evaluation. All parts 9.1 to 9.3.

10 – Improvement. All parts 10.1 to 10.3.

On-going report generation.

4.00 pm Closing meeting.

End of visit.

The objectives of the audit will be:

• To confirm that the management system had been established implemented and maintained in accordance with the

requirements of the audit standard.

• To evaluate the ability of the management system to ensure the client organisation meets applicable statutory, regulatory and

contractual requirements. Note: A management system certification audit is not a legal compliance audit.

• To evaluate the effectiveness of the management system to ensure it is continually meeting its specified objectives

• To identify as applicable, areas of the management system for potential improvement.

The audit scope describes the extent and boundaries of the audit, such as physical locations, organisational units, activities and processes to be audited.

Where the initial or re-certification process consists of more than one audit (e.g. covering different locations), the scope of an individual audit may

not cover the full certification scope, but the totality of audits shall be consistent with the scope in the certification document.


Audit Report Part D – Audit Matrix

Relevant Standard/Supporting Documentation: ISO 9001:2015

o This audit programme is to be prepared by the Lead Auditor at the completion of the Stage 2 audit or the Recertification audit. It

should be replicated in all subsequent surveillance visit reports.

o Where an element(s) of the programme cannot be completed at a given visit the programme shall be amended and up-issued

accordingly to ensure coverage at the following visit.

o Site visits are to be included in the programme with a clear indication as to the processes intended to be sampled.

Next visit is indicated in RED

Type of visit Stage 1 Stage 2 Surveillance 1 Surveillance 2 Recertification

Visit Due Date (MM/YY) 10/18 10/19 10/20

Mandatory Elements/Selected Processes

Processes to be audited during visits are to be indicated with a cross (X).

All processes are to be audited during a three year certification cycle excluding the re-

certification visit.

Context of the organization: Understanding the

organisation / Needs and expectations / Scope of

operations / Management System

X X X

Leadership: Focus / Policy / Roles and organisation X X X

Planning: Risks and opportunities / Objectives and

planning / Planning of changes X X X

Support: Resources / Competence / Awareness /

Communication / Documented information X X X

Performance evaluation: Internal audits /

Management review / Customer satisfaction X X X

Improvement: Nonconformity / Corrective action /

Continual improvement X X X

Use of marks and references to certification /

Client website X X X

Site Walk X X X

Operations Processes (specify)

Graphic design activity X X X

Film conversion activity X X X

Off Site Processes for review at Site Visits

(list below all areas requiring site visits)

Client Locations to be visited

(list below all client location to be visited)

Facility @ BD11 2PT X X X

Audit trails will be developed based upon identified risk throughout the audit and as such timings and content may be subject to change.

Where the client operates shifts, the activities that take place during shift working

shall be considered when developing the audit programme.

NQA MANAGEMENT SYSTEMS RECERTIFICATION (TRANSITION ...€¦ · John Early. Process Owner(s): NQA...

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