QUALITY MANAGEMENT PLAN

KHYBER BARA HOSPITAL

Group Members:
Asma Iqbal 1684197
Neha Haider 1684122
Shahzaib Qasim 1584264
Contents
QUALITY REQUIREMENTS & EXPECTATIONS:.............................................................................. 4
What to achieve: .................................................................................................................................... 4
QUALITY MANAGEMENT & ORGANIZATION: ............................................................................... 4
DOCUMENTS AND DATA:.................................................................................................................... 4
FRAMEWORK: ........................................................................................................................................ 4
QUALITY METRICS: .............................................................................................................................. 5
QUALITY RESPONSIBLE: ..................................................................................................................... 5
CHANGE MANAGEMENT: .................................................................................................................... 5
QUALITY ASSURANCE: ........................................................................................................................ 6
PROCEDURE........................................................................................................................................ 6
Planning Internal Audit.......................................................................................................................... 6
PERIODIC AUDIT ............................................................................................................................... 6
NEED BASED AUDIT ......................................................................................................................... 6
AUDIT PROCEDURE .......................................................................................................................... 6
Closing of Non-Conformances .............................................................................................................. 7
SELECTION OF AUDITORS .............................................................................................................. 7
PREPARING FOR QUALITY AUDIT ................................................................................................ 7
CONDUCT OF QUALITY AUDIT ...................................................................................................... 8
AUDIT RECORDS: .............................................................................................................................. 8
INTERNAL AUDIT NON-CONFORMANCE REPORT .................................................................... 8
INTERNAL AUDITORS ...................................................................................................................... 8
FOLLOW-UP ........................................................................................................................................ 9
FOLLOW-UP ACTION ........................................................................................................................ 9
Purchasing: ............................................................................................................................................ 9
Product Identification and Traceability: .............................................................................................. 10
Process /Project Control ...................................................................................................................... 10
Preventive Action (PA): ...................................................................................................................... 11
QUALITY CONTROL ............................................................................................................................ 11
DELIVERY & HANDLING ............................................................................................................... 11
TESTING ............................................................................................................................................. 11
Delivery of Material and Equipment to Site ........................................................................................ 11
Delivery of Materials to FSPs Site Store/Warehouse: ......................................................................... 11
Site Works – Civil ............................................................................................................................... 11
Incoming materials: ............................................................................................................................. 12
 In-process materials: ............................................................................................................................ 12
Final Inspection: ...................................................................................................................................... 12
Control of Inspection, Measuring and Test Equipment ....................................................................... 12
Inspection and Test Plan ...................................................................................................................... 13
Recommendations: .................................................................................................................................. 14
QUALITY REQUIREMENTS & EXPECTATIONS:

What to achieve:
Project scope: Reconstruction of a hospital – Khyber Bara
Duration: 300 days
Budget: $ 602610
Constraints: Security issue as it is situated in FATA near Pak-Afghan border.
Government regulations such as curfews and ongoing military operations
against militants.
Labor: They don’t have skilled labor nearby so they hire them on fixed pay.
Stakeholders: US-Aid, Fata secretariat, IOM(international organization for migration),
Pak Army, General public, Tribal Jirga’s Masha-ran (Amman Committee)
Procurement: Raw materials: steel, aluminum, sand, pipes, bricks, concrete, tough pavers
etc.
Sponsor: US-Aid

QUALITY MANAGEMENT & ORGANIZATION:

This quality plan covers all the scopes of kbari004 in accordance with FSP standards and specifications.

DOCUMENTS AND DATA:

Document and data control shall be in accordance to integrated procedure google docs- control of IMS
documents and control of record (IP/101 & IP/102s) and the following:

1. All incoming and outgoing of documents from FSP/donor/field office shall be stamped for circulation
and passed to the project manager followed by the rest of personnel involved. If reply is required, the
respective engineer shall follow up and report to the PE/tech manager before the project manager
reply to the client.
2. A copy of all incoming and outgoing documents shall be filed in accordance to project file format.

FRAMEWORK:
FSP has developed and implemented an Integrated Management System (IMS) in accordance with the
requirements of ISO 9001, OHSAS 18001 and ISO 14001 demonstrating organizational commitment
towards incorporating quality environmental responsibility and occupational health and safety best
practices.
QUALITY METRICS:
• Control of inspection, measuring and test equipment shall be in accordance with agreed donor
QCR and site visit note SVN and calibration reports are maintained by the operation departments.
• QA & QC engineer must accompany the team during each payment and nonpayment visit where
the main focus of QA & QC in the visit will be to check the quality of material (against agreed
specification), the quality of supplies (against agreed specification), workmanship and moreover
taking random measurement where it deemed necessary.
• The detail measurements should be taken critically in 75% and 100% site visit as the projects are
on the verge of closing and need to be calculated critically.
• Based on “feedback on donor satisfaction”, corrective action is taken within a month if level of
satisfaction is less than 70% and within six months if the level is more than 70%.
• On the measurement of performance indicators, corrective action is taken by the supplier processor
if the decline is observed to be more than 10% with respect to its target.

QUALITY RESPONSIBLE:

Quality Control Agency engineer

Quality Assurance MA (management representative)

All employees are responsible to raise a CAR.

CHANGE MANAGEMENT:
The review meeting shall be chaired by GM and he shall examine if the integrated management system is
effective. Once in a year, the quality policy and objectives will be reviewed for its continued suitability.
Any change in procedure or new procedure required for effective control of integrated management
system shall be discussed.

The meeting is attended by following members who have direct responsibility in implementing and
maintaining ‘policy statement’ of the organization and the integrated system procedures. In the absence of
any member, his authorized nominee attends the review meeting. The general manager or his authorized
representative chairs the meeting. The following personnel shall be notified to attend the review meeting:

● Program manager (PM)

● Management review committee members, comprising of HOD of all available departments
● Operations and HOD- purchase.
● Any other members as GM/MR deems fit.
The agenda shall be circulated to the above attendees, at least one week in advance.
QUALITY ASSURANCE:

PROCEDURE

Planning Internal Audit

The audit may be carried out in an integrated manner comprising by comity or individually.

Internal Audit is structured in two ways:

1. Periodic Audit

2. Need based Audit

PERIODIC AUDIT
Periodic Audit is carried out at least once in three months/ six months to check the overall effectiveness of
the QMS, EMS and OH&S. MR prepares an audit plan for a year. The audit is intimated to the
auditors/auditees through Audit Schedule (IEX01/IP/106). Audit schedule shows the departments to be
audited, area to be audited, period of audit and the personnel involved in the audit. The auditors chosen
are independent of activity / area being audited. The audit plan is revised by MR as and when required.

NEED BASED AUDIT

Need based audit is conducted in the following cases

1. Increase in Customer complaints

2. System updating
3. Significant Non-conformances reported
4. External accreditation
Need based audit is carried out to evaluate the implementation status of action initiated in situation
mentioned as above.

AUDIT PROCEDURE
The Internal Audit shall be planned and organized by the Management representative.

Audit is carried out based either on the periodic audit plan or need based requirements as mentioned in
4.1 and 4.2 respectively. Audit schedule is issued at least one week in advance by MR to the auditors and
auditees. All elements of the integrated system shall be audited in accordance with a planned schedule.
The auditee is typically a HOD or Manager or Supervisor responsible for implementing the procedure
being audited. Employees directly involved with the procedure are also involved in the audit.

MR briefs the auditors about depth and specific elements of the system to be audited where required. In
order to conduct the audit effectively, appropriate Audit Check List (IEX 06 /IP/106) is used by the
auditor.

The internal audit shall be carried out once in 3 or 6 months to cover the entire organizational integrated
system. The frequency of the audit, however, shall be increased in case of a high non-conformity level
found in any particular area in the previous audit or whenever a need arises, as decided by the
management.

Audit is carried out based on the documents connected with activity / area. This is identified in the audit
schedule as area to be audited. During each audit, the auditors also verify the effectiveness and
implementation of the corrective and preventive action taken on the earlier audit findings. The auditor
indicates compliance to relevant clauses in ‘Audit Observation Report’ (IEX05/IP/106) while non-
conformances against the clause are recorded in the Non-conformance Report (IEX02/IP/106). After
completion of audit, Audit Summary Report (IEX04/IP/106) is handed over to auditee by auditor.

The non-compliance findings of the audit is recorded and handed over to auditee through Non-
conformance report (NCR) by auditor. For non-conformances, auditee identifies timely correction,
root cause and corrective & preventive action in NCR forms, retains his copy for completion and
forward another one copy to Auditor / MR. Based on completion plan of correction and the corrective
and preventive action, the auditor / representative of MR verifies the closing status of NCR and forwards
to MR for further action.

Closing of Non-Conformances
Based on the verification and the remarks of the concerned auditor/representative of MR, the non-
conformances are closed by MR. NCRs not closed within target date are reviewed and fresh dates for
closure is agreed upon.

A Non Conformance Matrix (IEX03/IP/106) is prepared for Non-conformances department/ clause-

wise by MR.

SELECTION OF AUDITORS
The internal quality auditors shall be selected based on certain personal attributes such as objectivity,
integrity, an analytical approach, tact and good inter personal relations. Such auditors shall be trained and
necessary certificates shall be available.

Responsibility: MR

PREPARING FOR QUALITY AUDIT

The internal audit shall be followed as per this procedure. The first essential requirement is a standard
checklist, titled Internal Audit Check list (IEX06 /IP/106), which will be prepared in the form of a
questionnaire for the guidance of the audit team in compliance with various clauses of the integrated
system.

For the sake of objectivity, the audit team shall be composed of personnel from departments other than
those being audited.

The ‘Internal Audit Schedule’ shall be informed to the concerned departments at least one week in
advance.

Responsibility: Management Representative

The auditor nominated shall be responsible for the preparation, coordination execution and reporting of
the audit .Collect copy of procedure /manual, unfilled forms, audit report form etc from MR to report
NCR. Checklist and audit report numbers shall be provided by the auditor.

Responsibility: MR
CONDUCT OF QUALITY AUDIT
Internal audit shall be carried out as per the internal audit schedule and as per the Audit plan
(IEX07/IP/106)

Responsibility: MR

The auditor shall conduct audit of the current operating procedure, integrated manual, and work
instruction. The auditor shall record his observation to provide objective evidence of the audit carried out.
Any non-conformance found shall be detailed in the non-conformance report at the end of the audit.

When the audit is completed, the auditor shall provide a verbal summary of the audit observation
including non-conformances. Any non-conformances raised shall be provided to the auditee for his
signature to indicate his acceptance and commitment to correct the NC within an agreed period.

Responsibility: Internal Auditor

Review the audit reports of the previous audit, if any

Study recommendations made in the previous audit and assess current operations to determine whether
the non-conformities revealed by the previous audit have been eliminated.

Carry out a check using the standard Internal Audit Checklist

As a general rule, the auditors shall also seek to:

● Determine whether the documented procedures are lacking in any areas and need to be upgraded or
modified.
● Verify whether the documented procedures are adequate to ensure that the product meets the
customer’s requirements.

Whenever an auditor observes, a non-conformity in the system, all relevant evidence shall be examined
carefully and full details of the non-compliance or deficiency shall be recorded in the ‘Non-
Conformance Report’ (IEX 02/IP/ I06).

In addition to the above the auditors responsible for the functions being audited shall prepare an Audit
Summary Report (IEX04/IP/106) indicating the non-conformances observed against the clauses. This
shall be supplemented by Audit Observation Report (IEX05/IP/106), which will indicate the
opportunities for improvements.

Responsibility: Internal Auditors

AUDIT RECORDS:
A record of all audits is maintained by MR and relevant copies are held with respective departments.
These audit records form part of the agenda for management review meeting.

INTERNAL AUDIT NON-CONFORMANCE REPORT

INTERNAL AUDITORS
The internal audit non-conformance report shall contain the following information:
1. Report title, serial number, department name, areas audited, date of audit auditor’s name, Auditee
etc.
2. Summary of findings or observations, indicating the clause number
3. Root cause analysis
4. Corrective & Preventive actions Proposed by the auditee and commitment date.
5. Verification of corrective actions taken.
6. Closing of non-conformance by the auditor/MR.

The corrective action to be taken and the target date for completion shall be agreed between MR and
auditee. Corrective action shall be verified by MR and the status shall be updated in the system.

Responsibility: Internal Auditors

FOLLOW-UP
The Management Representative is responsible for the follow-up of the Internal Audit Non-conformance
Reports.

An Internal Audit Non-conformance Report copy shall be available with the auditor, the auditee and with
MR.

A consolidated audit finding shall be made and the number of non-conformances raised during the audit
against the departments shall be summarized and a Non Conformance Matrix. (IEX03/IP/I06) shall, be
prepared.

Responsibility: MR

The internal audit findings and the corrective action taken shall be reviewed in the Management Review
Committee.

Responsibility: MR/GM/HOD’s

FOLLOW-UP ACTION
Each auditor is responsible for follow-up with the concerned auditee to ensure corrective action is
implemented.

Project Quality Planned Date Auditors Comments

Audit Review

Purchasing:
Work instruction & form
The following are work instructions and form required for purchasing in accordance with quality system
procedure (QSP 006)

Requirement:
Material/ purchasing requisition form - FM/PUR/02-/-QSP/006
Supplier evaluation - FM/PUR/04-/-QSP/006
For purchasing status
1. All technical data sheet and catalogue data for every item of civil works, building materials and
equipment to be used in works shall be submitted in material submitted form submittal for approval
of material IEX 18/IP/105 rev 0 for approval of client.
2. Vendor will be selected from clients approved vendor list. If the good are not readily obtainable
and will have adverse impact on the project schedule then variation request will be raise to client
approval.
3. Purchase requisition shall be raised with form FM/PUR/02 and be compliance to customer
requirement, product specification and works requirement. Purchasing requisition shall contain data
describing accurately and completely the product ordered by using the supplier evaluation and
supplier approval note (QSP 006).
4. Equipment, other permanent materials for the work supplied shall be in order to assure
compliance to the procurement documents. This control consists of measures such as documented
evidence of quality furnished by the supplier, inspection or audits at the source and examination the
product delivery. Receipt of purchased items shall be controlled.
5. Inspection of materials to assure they are free of damage when delivered.
6. Review to assure that purchase compliance to specifications and requirements.
7. Vendors of main materials/ equipment and major sub-contractor of works shall submit copy of
their QA system for review and record.
8. Monitoring of material/ equipment ordering shall be assisted by QSP 006/ vendor evaluation and
approval.

Product Identification and Traceability:

The product identification and traceability shall be in accordance to the design and specifications
During receipt of the raw material, the item shall be identified with MRI & supplier’s name by ‘tag’ or
marker.

Material traceability report (IEX 16//IP/105) shall be maintained for all materials which are used for
the specific job for all erection and installation works.
Traceability is to know the process history of the particular order material from cutting up to erection and
constructing. It is in which the received material used for a particular activity erection/ constructing
mainly focused on steel, aluminum other.
The traceability record evidence is BOM, job card & in process inspection report.

Process /Project Control

The following is the integrated procedure and form required for process/ project control (control of
project processes) in accordance to integrated procedure.
Requirement:
Control and monitoring of project processes.
The process control shall follow the integrated work procedure. Project planning shall be assisted with the
project planning for scope of work/ supply from integrated work procedure.
 Preventive Action (PA):
Preventive action is to eliminate potential root cause of a non-conformance before occurrence. Preventive
action is taken based on various sources of information such as data on work instructions, audit results,
inspection and test records, C&PA reply, claim note, scrap notes, vendor rating, customer complaint
investigation report, customer satisfaction analysis report and snag/ visit report.
An analysis of the above inputs enables to determine the preventive action needed to deal with any non-
conformance commensurate with the magnitude of the problem. All functions are responsible for
identifying & implementing the preventive action and the ‘corrective & preventive action report’ (IEX
01/IP/108) is generated. The above is put up in management review meeting to review the effectiveness.

QUALITY CONTROL

DELIVERY & HANDLING

TESTING
1. Prior to delivery of materials/ equipment to site, all supplier test report or delivery form and company
registration certificate executed as to the relevant codes or standards as stipulated in the contract must be
obtained from the vendor.
2. Where witness is required, client’s appointed inspecting engineer shall witness and the reports
approved by the client.
3. The test reports and third party inspection will be in accordance to the client specification.

Delivery of Material and Equipment to Site

1. All procedure of delivery must be in accordance to client’s specification.
2. All major items or equipment shipped to site, a notice of 21 days shall be given to client.
3. All material and equipment delivered to site must be inspected by agency engineer and/ or our site
supervisor and /or agency engineer and properly documented unless inspection has been waived off the
client/FSP.
4. Receipt of goods shall be controlled by inspection of components by agency engineer to ensure they
are in good quality and in accordance to purchase order/ approved vendor drawings and client
specification.
5. Receiving cum inspection report will submit to cover each shipment received and checked on site.
All receiving-cum-inspection report along with the supporting documents i.e. Delivering invoice, material
submittals, MSDs etc. shall be attached and submitted to musanada approval.
Delivery of Materials to FSPs Site Store/Warehouse:
All material/ equipment shall be inspected internally in accordance to IP/105 prior to delivery to FSP site
store.
As and when required, FSP will ask permission to donor for the usage of warehouse away from site and
inspection of all equipment and material.

Site Works – Civil

1. All construction works shall be ensure that the construction is completed to the standard of neatness,
specification, method of statement and manufacturing standards as agreed with donor.
2. FSPS engineer/contractor has to adhere to client’s in-house rule on permit-to-work system during the
construction period.
 3. Internal audit (refer IP/106)/ in process inspection (refer IP/105) activities shall be performed during
construction of the boundary wall works, so that problems are detected in a timely manner that would
permit necessary repairs or resolutions without unduly delaying the project progress schedule.
4. Any serious non-conformity or ignorance by suppliers shall be recorded in non-conformance report
(iex02/ip/106) and forwarded to the supplier. Necessary correction and prevention action shall be
carried out by the suppliers in accordance with the capa report.
5. All site construction or civil work must be inspected by our agency engineer and or site engineer and
the inspection form filled by the supervisor or engineer before final casting/ finishing works.
6. All rework, if-any, has to be re-inspected by the site engineer. In another case, another form to be
recorded.

CORRECTION:
Criteria for initiating the corrective action in various areas, is indicated hereunder. Alternatively in
general, depending upon the magnitude of the non-conformance, corrective action is taken.

Incoming materials:
Any deviation noticed on the purchased material or during the execution of the order, the QC engineer
shall prepare NC report and forward to pm for taking necessary deviation.
Responsibility: QC Engineer
Any deviation observed on the stock material (e.g. Damage, deterioration, deformation) shall be reported
by store keeper or QC engineer and forwarded to QC manager for necessary action.
Responsibility: Store Keeper/QC Engineer
All employees are authorized to raise a car, when any deviation is noticed in their area of work .the CAPA
will be forwarded to MR for necessary action.
Responsibility: All Employees
Customer complaints received at office /site shall be reviewed by gm and necessary CAPA (IEX
01/IP/I08) will be taken.
Responsibility: MR

In-process materials:
NCs noticed at in-process stage are identified by QAD and the root cause is analyzed and necessary
corrective and preventive action is initiated.
The effectiveness of corrective action is verified by QAD subsequently.

Final Inspection:
SCCs noticed at final inspection are identified by project /QAD and root cause is analyzed and necessary
CAPA is taken. The effectiveness of corrective action is verified by QAD.

Control of Inspection, Measuring and Test Equipment

Control of inspection, measuring and test equipment shall be in accordance with agreed donor QCR and
site visit note SVN and calibration reports are maintained by the operation departments.
QA & QC engineer must accompany the team during each payment and nonpayment visit where the main
focus of QA &QC in the visit will be to check the quality of material (against agreed specification), the
quality of supplies (against agreed specification), workmanship and moreover taking random
measurement where it deemed necessary.
The detail measurements should be taken critically in 75% and 100% site visit as the projects are on the
verge of closing and need to be calculated critically.

Inspection and Test Plan

Inspection and test will be traditionally served as the verification of conformance for the product to be
classified.
Inspection and test plan will be developed and submitted to the client in the acceptable manner for all
major activities required to undertake the works assure that all inspection and test are conducted to
confirm compliance with the specification.
All the major materials like steel, sand, pipes, bricks, concrete, tough paver’s etc. they Needs to be tested
in front of FSP engineer and the report to be submitted to QA & QC department.
Inspection and test status shall be in accordance to client specification/ IP/105 (control and monitoring of
project processes) whichever is applicable.
Minimum inspection time shall be in accordance to donor specifications.
Recommendations:

1. Organization’s corrective action definition is different from the standards, and they need to revise
their definitions as per the standard.

Term Incorrect Definition Correct Definition

Corrective Action taken to correct any deviations Actions taken to correct any observed
Action Observed. deviations so that they will not occur again.

2. We recommend the organization to train their employees especially regarding the training of
auditors so that they are able to collect substantial evidence in order to evaluate how well audit
criteria’s are being met.
3. As this is a government project they should conduct Desktop Audits to ensure compliance
to higher level documents and to familiarize auditor with the auditee's quality system.
4. They haven’t explained the project’s deliverables in the Quality Management Plan. They are
emphasizing on materials rather than the actual project deliverables in the Quality Control
Process. Hence we recommend that they prepare a checklist in accordance with the
requirements of the customer so that it’s easy for the Inspector to conduct the final
Inspection.